OBG Management

The world of minimally invasive gynecologic surgery has been transformed over the past 10 months—specifically in regard to the option of open power morcellation. From individual hospital bans of the procedure to an official warning from the US Food and Drug Administration (FDA)¹ and the potential for further government action, the change has been swift and certain. ­Johnson & Johnson has recalled all power morcellators, many institutions now have bans in place, and one major insurer has announced its plan to discontinue coverage of power morcellation in three states.

What effect have these actions had on the availability of minimally invasive approaches to benign hysterectomy and myomectomy? And given new information on the risk of occult malignancy during these surgeries, how has patient selection and preoperative assessment changed? To address these and other questions, OBG ­ Management convened a panel of experts in minimally invasive gynecology and asked them to share their perspective. In this case-based discussion, they offer their views on the morcellation controversy and their current approach to hysterectomy, myomectomy, and tissue extraction. Next month, in Part 2 of their discussion, they address patient counseling and FDA actions.

What is your preferred approach?

OBG Management: In light of the morcellation controversy, what is your preferred approach for benign hysterectomy?

Kimberly Kho, MD, MPH: Whenever possible and appropriate, vaginal hysterectomy is my preferred route. However, many surgical cases require evaluation of the abdominal cavity for pain, endometriosis, or a concerning adnexal mass. In such cases, and in cases involving a very large uterus, I prefer laparoscopic hysterectomy—either laparoscopic-assisted vaginal hysterectomy or total laparoscopic hysterectomy (TLH). I tend to perform TLH more frequently in these cases if the uterus lacks descent or the patient’s anatomy restricts vaginal access. Even in these cases, and with very large myomas and uteri, I have been successful removing the uterus vaginally, although this approach frequently involves vaginal morcellation with a scalpel.

Arnold P. Advincula, MD: My preferred approach for both benign hysterectomy and myomectomy is robot-assisted laparoscopy. I have used this approach over the past 13 years. In my hands, it is reproducible, safe, efficient, and cost-effective and affords me the ability to tackle a wide range of complex cases.

Cheryl Iglesia, MD: Like Dr. Kho, I prefer vaginal hysterectomy.

Jason D. Wright, MD: I also prefer the vaginal approach. In fact, I believe it should be the preferred approach for hysterectomy for benign gynecologic disease whenever it is feasible. And the laparoscopic and robot-assisted approaches carry less perioperative morbidity than abdominal hysterectomy.

Given the recent concerns about open power morcellation, I prefer to perform either vaginal hysterectomy or minimally invasive hysterectomy without morcellation. If neither approach is feasible, given anatomic considerations, I counsel the patient about the risks and benefits of abdominal hysterectomy, compared with minimally invasive hysterectomy with morcellation.

Linda D. Bradley, MD: For women who meet minimally invasive surgical criteria, I prefer the laparoscopic approach because of its many benefits, including a shorter hospital stay (which reduces the risk of ­hospital-acquired infection and iatrogenic complications of hospitalization), lower risk of incisional infection, lower requirement for pain medications, and faster return to work.

OBG Management: What about myomectomy? Would your approach be different?

Dr. Bradley: Many myomectomy cases can be done hysteroscopically. I would like to point out, however, that when we talk about hysteroscopy, the morcellation issue is moot. Although there are hysteroscopic surgical devices that have used the word “morcellator” in their names, hysteroscopic morcellation is performed within a closed system—the uterine cavity—and so carries none of the risks of laparoscopic morcellation.

I prefer to perform nonhysteroscopic cases using a laparoscopic approach, creating a small mini-laparotomy to remove the fibroid intact or using a knife to morcellate the tissue outside of the peritoneal cavity.

Dr. Kho: I use a similar laparoscopic approach for myomectomy, using laparoscopy to assess the uterus and fibroids, enucleate the fibroid and remove it from the uterus, and then creating a mini-laparotomy incision
3 cm to 4 cm in length to manually remove or morcellate the fibroid and reapproximate the myometrium.

Dr. Iglesia: I rarely perform myomectomy but would likely do it laparoscopically or robotically to achieve minimally invasive benefits such as fewer adhesions and less postoperative pain.

How do you manage tissue extraction?

OBG Management: What methods of tissue extraction do you currently use during hysterectomy and myomectomy?

Dr. Advincula: I currently utilize a contained, extracorporeal, transumbilical, manual ­scalpel-morcellation technique for all myomectomy cases, as well as hysterectomy cases not amenable to transvaginal extraction.

Dr. Iglesia: I rely on vaginal removal of tissue and vaginal morcellation.

Dr. Kho: I infrequently perform supracervical hysterectomy, so almost all the hysterectomies I do are total hysterectomies. I remove the uterus through the vagina. In addition, because the size of the specimen frequently is too large to remove through a colpotomy intact, I morcellate the uterus manually with a scalpel using coring, wedge resection, and myomectomy. I find this to be an efficient and controlled method for tissue removal, with minimal tissue scattering. I also have begun to perform the same type of vaginal morcellation with the specimen enclosed in a bag.

That being said, the spread of occult malignancy has been reported after all types of morcellation—not just with power morcellation but also with vaginal and abdominal morcellation. So we are increasingly performing tissue extraction in an enclosed fashion using manual morcellation in a containment bag through a mini-laparotomy or posterior colpotomy to minimize the risk of leaving tissue fragments behind.

Dr. Wright: Although different methods of tissue extraction, including morcellation within a bag, are commonly discussed, data documenting the safety of these methods are extremely limited and patients should be counseled accordingly.

Similarly, the risk of adverse pathology increases substantially with age, and morcellation should be considered with great caution—if at all—in older women.

Given the risks associated with power morcellation, I try to avoid uterine disruption at the time of hysterectomy and perform either vaginal or minimally invasive total hysterectomy. In older women, because of the higher risk of underlying pathology, I prefer laparotomy if anatomic considerations preclude a vaginal or minimally invasive total hysterectomy. Younger women can be counseled about the risks and benefits of various routes of extraction. Patients with any suspicious findings during preoperative evaluation or surgery itself should have their uterus removed without disruption or fragmentation.

In regard to myomectomy specifically, a significant portion of the data we have on the risks of power morcellation derives from studies of hysterectomy. There are minimal data describing the risk of occult pathology at the time of minimally invasive myomectomy. Although younger patients likely are at relatively low risk for occult malignancy, they should be counseled that population-based estimates of cancer at the time of myomectomy are lacking.

Dr. Bradley: Since the controversy over morcellation arose, the Cleveland Clinic not only has banned the procedure but also removed all morcellators from its shelves, and it is unclear whether the option will be revisited after the FDA renders its final verdict. So my approach to tissue extraction is either vaginal morcellation or using a mini-laparotomy to remove the whole specimen intact or put it in a bag and morcellate it with a knife.

Case 1: A premenopausal patient scheduled for myomectomy

OBG Management: Let’s move on to a specific case. Let’s say the patient is a 35-year-old woman with a large fibroid, to be removed by myomectomy. How would you quantify her risk of occult malignancy? And what would preoperative assessment entail?

Dr. Iglesia: This patient’s risk of occult malignancy is low. I would obtain pelvic ultrasonography and endometrial biopsy, with cervical cytology included. Preoperative magnetic resonance imaging (MRI) would be indicated if there is a possibility that power morcellation will be performed. If power morcellation were selected, I would perform it using a bag.

Dr. Bradley: At the Cleveland Clinic, we now utilize the FDA risk estimates for occult malignancy of 1 in 300 to 1 in 350 women,¹ and I counsel patients using these figures. In the past several years, we have begun to use MRI with and without contrast to determine the size, number, and location of the fibroids, to determine our surgical approach, and to guide our discussion with the patient of what we will be able to do—for example, laparoscopy versus laparotomy.

OBG Management: Would the FDA figures you give be applicable to a young woman such as this 35-year-old?

Dr. Bradley: We’re using those figures with all of our premenopausal patients.

OBG Management: And does the MRI pick up sarcomas?

Dr. Bradley: No imaging is 100% sensitive in detecting sarcoma. We do MRI, and if the fibroid has any areas of necrosis, irregularity, or poor tissue planes that would arouse our suspicion of adenomyoma or sarcoma, we perform the myomectomy via laparotomy. But as I mentioned earlier, we don’t use power morcellation at all anymore—so this patient you describe would likely undergo laparoscopic removal using a bag and a knife to extract it to the skin level.

Although every patient is different, in general, if we have a patient with a single large fibroid 10 cm or less in size, we try to remove it laparoscopically or with robot ­assistance rather than via laparotomy. We also perform endometrial biopsy.

Dr. Advincula: First, it’s important to define prevalence and incidence when discussing risks. Prevalence would be the number of patients with a leiomyosarcoma per 100,000 women, whereas incidence is the number of patients given a diagnosis of leiomyosarcoma within a year per 100,000 women. In this case, a 35-year-old woman would have a prevalence of leiomyosarcoma, in the general population, of 3 to 7 per 100,000 women and an incidence of less than 1%.

My preoperative assessment would involve MRI of the pelvis with T2 weighted images to better characterize her uterus. Although there has been much discussion lately about the use of lactate dehydrogenase (LDH) isoenzyme panels in combination with MRI to detect occult leiomyosarcoma, the reliability and reproducibility of that combined approach are not fully vetted and, as yet, are not a standard part of my workup. Endometrial sampling would certainly be warranted with any associated history of abnormal uterine bleeding.

Dr. Wright: As I mentioned earlier, most data on power morcellation have been derived from studies of women undergoing hysterectomy. To date, accurate estimates to predict the risk of occult cancer in this patient planning to undergo myomectomy are largely lacking. For women undergoing hysterectomy using power morcellation, advanced age is the strongest risk factor for occult malignancy. Although this patient’s risk of cancer likely is relatively low, she should be counseled that precise estimates are lacking.

Preoperatively, she should undergo endometrial sampling if she has abnormal bleeding. However, the reliability of endometrial sampling, as well as imaging, is limited in the detection of uterine sarcomas.

Case 2: Perimenopausal patient undergoing hysterectomy

OBG Management: How would your approach to preoperative assessment change if this patient were a 47-year-old ­perimenopausal woman with a single large fibroid to be removed by hysterectomy?

Dr. Bradley: It would be the same preoperative assessment—an MRI and an endometrial biopsy.

Dr. Iglesia: The risk of occult malignancy would be greater than with the first patient. Again, I would use pelvic ultrasound, endometrial biopsy, and cervical cytology to assess her, and I would perform vaginal or TLH. MRI would be indicated if there is a possibility of performing intraperitoneal morcellation. I would prefer doing any morcellation in a bag or via laparotomy.

Dr. Wright: Based on age alone, this perimenopausal patient’s risk for an underlying cancer is 0.2%.² If the patient has any abnormal bleeding, she should undergo endometrial sampling preoperatively. The diagnostic modalities currently available—which include endometrial sampling as well as imaging, even MRI—are unreliable in the diagnosis of uterine sarcomas, and the patient should be counseled accordingly if she is considering power morcellation.

If it is technically feasible, vaginal hysterectomy or a minimally invasive hysterectomy without power morcellation are preferred. If neither modality is feasible and the patient is considering power morcellation, she should be carefully counseled about the underlying risk not only of uterine cancer but also of other adverse pathologic abnormalities.

Case 3: Postmenopausal woman scheduled for hysterectomy

OBG Management: Let’s change the details of the case again. This time she’s 55 years old and postmenopausal. She, too, has a large fibroid to be removed via hysterectomy. What is her risk of occult cancer? How would you assess her preoperatively?

Dr. Bradley: My approach would be the same as in the first two cases. However, because this patient is menopausal, morcellation would be off the table. (And it already is off the table—for any patient—at the ­Cleveland Clinic.) I usually prefer open hysterectomy for these patients, which is very different from what we were doing 1 year ago.

I want to expand on Dr. Wright’s comments about other pathologic abnormalities. As a woman ages, her cancer risk becomes greatest for malignancy of the endometrium rather than cancer in a fibroid. If this were my 55-year-old patient, and I had been seeing her for 20 years, and her fibroids had remained the same size but she was now having bleeding, I’d be more concerned about an endometrial problem—hyperplasia, a polyp, or cancer.

If the patient were having bulk symptoms, new pain, and imaging that shows, over 10 years between perimenopause and postmenopause, that there has been growth of the fibroids, I would be concerned about a sarcoma.

Some women who present with postmenopausal bleeding have ovarian cancer, and some studies show that a significant percentage of women with ovarian cancer present with bleeding as a primary symptom.³ So in a postmenopausal patient, I really want to know about the health of the ovaries. Are they enlarged on imaging?

There is also a bimodal distribution of human papillomavirus (HPV) infection and cervical cancer, with peaks of infection at ages 26 to 30 years and again at 46 to 50 years in some populations. The second age peak is followed by an increase in cervical intraepithelial neoplasia (CIN) 2 and 3 and invasive cervical cancer 20 years later.⁴ So I also want to consider the possibility of cervical cancer in this population.

I tell my patients that pretty much everybody has fibroids. Because they are so common, I need to look at the whole picture.

Dr. Wright: For the perimenopausal and postmenopausal patients we are discussing, preoperative evaluation and counseling would be similar to that for the premenopausal woman. However, given recent data, it is important to note that the prevalence ratio for a uterine malignancy increases with increasing age.² Clinicians need to be mindful of red flags in perimenopausal and postmenopausal women.

Dr. Kho: I agree that, for each of the cases we have discussed, we need to consider more than just the presence of the fibroid. Risk stratification based on clinical factors like age, menopausal status, BMI, the indication for surgery, and response to any other therapy is extremely important and should guide decision-making regarding the surgical approach.

Although we lack reliable methods to differentiate fibroids from leiomyosarcomas, there are other malignant conditions of the uterus, as Dr. Bradley pointed out. Premalignant conditions of the uterus and cervix and endometrial adenocarcinomas occur far more frequently in the population than sarcomas, and we may be increasing risks by morcellating unsuspected cancers of any type.

At this time, whenever I am considering morcellation in any patient, I obtain pelvic imaging, endometrial biopsy, and current cervical cancer screening. If any of these studies suggest a malignant or premalignant condition, I avoid morcellation. Similarly, if a patient’s clinical history raises suspicion of a potential underlying malignant process, such as new symptoms of an enlarging myoma in a postmenopausal woman, I will try to find an alternative to morcellation.

Why we need a national surgery registry
The controversy surrounding open power morcellation was precipitated by the reporting of a single case—that of a prominent physician who had an unsuspected cancer morcellated during the course of a hysterectomy and was later upgraded to Stage 4 leiomyosarcoma as a result. But it wasn’t a gynecologic surgeon who reported the case—it was the patient herself. And we all know she was by no means the first case of an inadvertently morcellated sarcoma.

I would wager that few physicians are well versed in how to contact the FDA’s Manufacturer and User Facility Device Experience (MAUDE) database. And not many are familiar with the other specialized registries in the United States, let alone know how to report to them. Another important but often unaddressed issue: Is it hassle-free to make a report? The answer: A resounding “No.”

Who do we inform about our experiences—successful or not—in the operating room? And who pays for data collection? At present, the system is piecemeal or scattershot at best.

Sorely needed is a system for reporting that is easy to use, broad, and deep. A nationally funded system would be best. Otherwise, who is going to maintain the database? Who will filter the data? Who will ensure that the information that is entered is correct so that outcomes can be followed accurately?

For those of us employed by a hospital or other institution, it tends to be the institution itself that gathers the data—when it is gathered. But what about surgeons in private practice? How do they monitor themselves? And what about privately owned outpatient surgery centers, where patients sojourn no longer than 23 hours? Is it reasonable to expect them to add the burden and expense of data collection without a national mandate?

I know firsthand some of the skewed information that results when reporting is piecemeal or manipulated. When I was a resident, for example, in some localities, it was not uncommon for sexually transmitted diseases to go unreported when the patient had private insurance. The result: Only those in the lower socioeconomic ranks appeared to experience this problem.

Clearly, we need national standards and a national protocol. And to achieve that we need leaders strong enough to argue that the expense represents dollars well spent.
                                                                                                                                                  - Linda D. Bradley, MD                                                                                                    

Quick Poll:
If you are using, plan to use, or anticipate the possibility of using power morcellation during minimally invasive gynecologic surgery, does your consent process include a separate form specific to power morcellation?
Please provide your answer to this question in the Quick Poll on the OBG Management home page and then see how your peers have voted.

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The world of minimally invasive gynecologic surgery has been transformed over the past 10 months—specifically in regard to the option of open power morcellation. From individual hospital bans of the procedure to an official warning from the US Food and Drug Administration (FDA)¹ and the potential for further government action, the change has been swift and certain. ­Johnson & Johnson has recalled all power morcellators, many institutions now have bans in place, and one major insurer has announced its plan to discontinue coverage of power morcellation in three states.

What effect have these actions had on the availability of minimally invasive approaches to benign hysterectomy and myomectomy? And given new information on the risk of occult malignancy during these surgeries, how has patient selection and preoperative assessment changed? To address these and other questions, OBG ­ Management convened a panel of experts in minimally invasive gynecology and asked them to share their perspective. In this case-based discussion, they offer their views on the morcellation controversy and their current approach to hysterectomy, myomectomy, and tissue extraction. Next month, in Part 2 of their discussion, they address patient counseling and FDA actions.

What is your preferred approach?

OBG Management: In light of the morcellation controversy, what is your preferred approach for benign hysterectomy?

Kimberly Kho, MD, MPH: Whenever possible and appropriate, vaginal hysterectomy is my preferred route. However, many surgical cases require evaluation of the abdominal cavity for pain, endometriosis, or a concerning adnexal mass. In such cases, and in cases involving a very large uterus, I prefer laparoscopic hysterectomy—either laparoscopic-assisted vaginal hysterectomy or total laparoscopic hysterectomy (TLH). I tend to perform TLH more frequently in these cases if the uterus lacks descent or the patient’s anatomy restricts vaginal access. Even in these cases, and with very large myomas and uteri, I have been successful removing the uterus vaginally, although this approach frequently involves vaginal morcellation with a scalpel.

Arnold P. Advincula, MD: My preferred approach for both benign hysterectomy and myomectomy is robot-assisted laparoscopy. I have used this approach over the past 13 years. In my hands, it is reproducible, safe, efficient, and cost-effective and affords me the ability to tackle a wide range of complex cases.

Cheryl Iglesia, MD: Like Dr. Kho, I prefer vaginal hysterectomy.

Jason D. Wright, MD: I also prefer the vaginal approach. In fact, I believe it should be the preferred approach for hysterectomy for benign gynecologic disease whenever it is feasible. And the laparoscopic and robot-assisted approaches carry less perioperative morbidity than abdominal hysterectomy.

Given the recent concerns about open power morcellation, I prefer to perform either vaginal hysterectomy or minimally invasive hysterectomy without morcellation. If neither approach is feasible, given anatomic considerations, I counsel the patient about the risks and benefits of abdominal hysterectomy, compared with minimally invasive hysterectomy with morcellation.

Linda D. Bradley, MD: For women who meet minimally invasive surgical criteria, I prefer the laparoscopic approach because of its many benefits, including a shorter hospital stay (which reduces the risk of ­hospital-acquired infection and iatrogenic complications of hospitalization), lower risk of incisional infection, lower requirement for pain medications, and faster return to work.

OBG Management: What about myomectomy? Would your approach be different?

Dr. Bradley: Many myomectomy cases can be done hysteroscopically. I would like to point out, however, that when we talk about hysteroscopy, the morcellation issue is moot. Although there are hysteroscopic surgical devices that have used the word “morcellator” in their names, hysteroscopic morcellation is performed within a closed system—the uterine cavity—and so carries none of the risks of laparoscopic morcellation.

I prefer to perform nonhysteroscopic cases using a laparoscopic approach, creating a small mini-laparotomy to remove the fibroid intact or using a knife to morcellate the tissue outside of the peritoneal cavity.

Dr. Kho: I use a similar laparoscopic approach for myomectomy, using laparoscopy to assess the uterus and fibroids, enucleate the fibroid and remove it from the uterus, and then creating a mini-laparotomy incision
3 cm to 4 cm in length to manually remove or morcellate the fibroid and reapproximate the myometrium.

Dr. Iglesia: I rarely perform myomectomy but would likely do it laparoscopically or robotically to achieve minimally invasive benefits such as fewer adhesions and less postoperative pain.

How do you manage tissue extraction?

OBG Management: What methods of tissue extraction do you currently use during hysterectomy and myomectomy?

Dr. Advincula: I currently utilize a contained, extracorporeal, transumbilical, manual ­scalpel-morcellation technique for all myomectomy cases, as well as hysterectomy cases not amenable to transvaginal extraction.

Dr. Iglesia: I rely on vaginal removal of tissue and vaginal morcellation.

Dr. Kho: I infrequently perform supracervical hysterectomy, so almost all the hysterectomies I do are total hysterectomies. I remove the uterus through the vagina. In addition, because the size of the specimen frequently is too large to remove through a colpotomy intact, I morcellate the uterus manually with a scalpel using coring, wedge resection, and myomectomy. I find this to be an efficient and controlled method for tissue removal, with minimal tissue scattering. I also have begun to perform the same type of vaginal morcellation with the specimen enclosed in a bag.

That being said, the spread of occult malignancy has been reported after all types of morcellation—not just with power morcellation but also with vaginal and abdominal morcellation. So we are increasingly performing tissue extraction in an enclosed fashion using manual morcellation in a containment bag through a mini-laparotomy or posterior colpotomy to minimize the risk of leaving tissue fragments behind.

Dr. Wright: Although different methods of tissue extraction, including morcellation within a bag, are commonly discussed, data documenting the safety of these methods are extremely limited and patients should be counseled accordingly.

Similarly, the risk of adverse pathology increases substantially with age, and morcellation should be considered with great caution—if at all—in older women.

Given the risks associated with power morcellation, I try to avoid uterine disruption at the time of hysterectomy and perform either vaginal or minimally invasive total hysterectomy. In older women, because of the higher risk of underlying pathology, I prefer laparotomy if anatomic considerations preclude a vaginal or minimally invasive total hysterectomy. Younger women can be counseled about the risks and benefits of various routes of extraction. Patients with any suspicious findings during preoperative evaluation or surgery itself should have their uterus removed without disruption or fragmentation.

In regard to myomectomy specifically, a significant portion of the data we have on the risks of power morcellation derives from studies of hysterectomy. There are minimal data describing the risk of occult pathology at the time of minimally invasive myomectomy. Although younger patients likely are at relatively low risk for occult malignancy, they should be counseled that population-based estimates of cancer at the time of myomectomy are lacking.

Dr. Bradley: Since the controversy over morcellation arose, the Cleveland Clinic not only has banned the procedure but also removed all morcellators from its shelves, and it is unclear whether the option will be revisited after the FDA renders its final verdict. So my approach to tissue extraction is either vaginal morcellation or using a mini-laparotomy to remove the whole specimen intact or put it in a bag and morcellate it with a knife.

Case 1: A premenopausal patient scheduled for myomectomy

OBG Management: Let’s move on to a specific case. Let’s say the patient is a 35-year-old woman with a large fibroid, to be removed by myomectomy. How would you quantify her risk of occult malignancy? And what would preoperative assessment entail?

Dr. Iglesia: This patient’s risk of occult malignancy is low. I would obtain pelvic ultrasonography and endometrial biopsy, with cervical cytology included. Preoperative magnetic resonance imaging (MRI) would be indicated if there is a possibility that power morcellation will be performed. If power morcellation were selected, I would perform it using a bag.

Dr. Bradley: At the Cleveland Clinic, we now utilize the FDA risk estimates for occult malignancy of 1 in 300 to 1 in 350 women,¹ and I counsel patients using these figures. In the past several years, we have begun to use MRI with and without contrast to determine the size, number, and location of the fibroids, to determine our surgical approach, and to guide our discussion with the patient of what we will be able to do—for example, laparoscopy versus laparotomy.

OBG Management: Would the FDA figures you give be applicable to a young woman such as this 35-year-old?

Dr. Bradley: We’re using those figures with all of our premenopausal patients.

OBG Management: And does the MRI pick up sarcomas?

Dr. Bradley: No imaging is 100% sensitive in detecting sarcoma. We do MRI, and if the fibroid has any areas of necrosis, irregularity, or poor tissue planes that would arouse our suspicion of adenomyoma or sarcoma, we perform the myomectomy via laparotomy. But as I mentioned earlier, we don’t use power morcellation at all anymore—so this patient you describe would likely undergo laparoscopic removal using a bag and a knife to extract it to the skin level.

Although every patient is different, in general, if we have a patient with a single large fibroid 10 cm or less in size, we try to remove it laparoscopically or with robot ­assistance rather than via laparotomy. We also perform endometrial biopsy.

Dr. Advincula: First, it’s important to define prevalence and incidence when discussing risks. Prevalence would be the number of patients with a leiomyosarcoma per 100,000 women, whereas incidence is the number of patients given a diagnosis of leiomyosarcoma within a year per 100,000 women. In this case, a 35-year-old woman would have a prevalence of leiomyosarcoma, in the general population, of 3 to 7 per 100,000 women and an incidence of less than 1%.

My preoperative assessment would involve MRI of the pelvis with T2 weighted images to better characterize her uterus. Although there has been much discussion lately about the use of lactate dehydrogenase (LDH) isoenzyme panels in combination with MRI to detect occult leiomyosarcoma, the reliability and reproducibility of that combined approach are not fully vetted and, as yet, are not a standard part of my workup. Endometrial sampling would certainly be warranted with any associated history of abnormal uterine bleeding.

Dr. Wright: As I mentioned earlier, most data on power morcellation have been derived from studies of women undergoing hysterectomy. To date, accurate estimates to predict the risk of occult cancer in this patient planning to undergo myomectomy are largely lacking. For women undergoing hysterectomy using power morcellation, advanced age is the strongest risk factor for occult malignancy. Although this patient’s risk of cancer likely is relatively low, she should be counseled that precise estimates are lacking.

Preoperatively, she should undergo endometrial sampling if she has abnormal bleeding. However, the reliability of endometrial sampling, as well as imaging, is limited in the detection of uterine sarcomas.

Case 2: Perimenopausal patient undergoing hysterectomy

OBG Management: How would your approach to preoperative assessment change if this patient were a 47-year-old ­perimenopausal woman with a single large fibroid to be removed by hysterectomy?

Dr. Bradley: It would be the same preoperative assessment—an MRI and an endometrial biopsy.

Dr. Iglesia: The risk of occult malignancy would be greater than with the first patient. Again, I would use pelvic ultrasound, endometrial biopsy, and cervical cytology to assess her, and I would perform vaginal or TLH. MRI would be indicated if there is a possibility of performing intraperitoneal morcellation. I would prefer doing any morcellation in a bag or via laparotomy.

Dr. Wright: Based on age alone, this perimenopausal patient’s risk for an underlying cancer is 0.2%.² If the patient has any abnormal bleeding, she should undergo endometrial sampling preoperatively. The diagnostic modalities currently available—which include endometrial sampling as well as imaging, even MRI—are unreliable in the diagnosis of uterine sarcomas, and the patient should be counseled accordingly if she is considering power morcellation.

If it is technically feasible, vaginal hysterectomy or a minimally invasive hysterectomy without power morcellation are preferred. If neither modality is feasible and the patient is considering power morcellation, she should be carefully counseled about the underlying risk not only of uterine cancer but also of other adverse pathologic abnormalities.

Case 3: Postmenopausal woman scheduled for hysterectomy

OBG Management: Let’s change the details of the case again. This time she’s 55 years old and postmenopausal. She, too, has a large fibroid to be removed via hysterectomy. What is her risk of occult cancer? How would you assess her preoperatively?

Dr. Bradley: My approach would be the same as in the first two cases. However, because this patient is menopausal, morcellation would be off the table. (And it already is off the table—for any patient—at the ­Cleveland Clinic.) I usually prefer open hysterectomy for these patients, which is very different from what we were doing 1 year ago.

I want to expand on Dr. Wright’s comments about other pathologic abnormalities. As a woman ages, her cancer risk becomes greatest for malignancy of the endometrium rather than cancer in a fibroid. If this were my 55-year-old patient, and I had been seeing her for 20 years, and her fibroids had remained the same size but she was now having bleeding, I’d be more concerned about an endometrial problem—hyperplasia, a polyp, or cancer.

If the patient were having bulk symptoms, new pain, and imaging that shows, over 10 years between perimenopause and postmenopause, that there has been growth of the fibroids, I would be concerned about a sarcoma.

Some women who present with postmenopausal bleeding have ovarian cancer, and some studies show that a significant percentage of women with ovarian cancer present with bleeding as a primary symptom.³ So in a postmenopausal patient, I really want to know about the health of the ovaries. Are they enlarged on imaging?

There is also a bimodal distribution of human papillomavirus (HPV) infection and cervical cancer, with peaks of infection at ages 26 to 30 years and again at 46 to 50 years in some populations. The second age peak is followed by an increase in cervical intraepithelial neoplasia (CIN) 2 and 3 and invasive cervical cancer 20 years later.⁴ So I also want to consider the possibility of cervical cancer in this population.

I tell my patients that pretty much everybody has fibroids. Because they are so common, I need to look at the whole picture.

Dr. Wright: For the perimenopausal and postmenopausal patients we are discussing, preoperative evaluation and counseling would be similar to that for the premenopausal woman. However, given recent data, it is important to note that the prevalence ratio for a uterine malignancy increases with increasing age.² Clinicians need to be mindful of red flags in perimenopausal and postmenopausal women.

Dr. Kho: I agree that, for each of the cases we have discussed, we need to consider more than just the presence of the fibroid. Risk stratification based on clinical factors like age, menopausal status, BMI, the indication for surgery, and response to any other therapy is extremely important and should guide decision-making regarding the surgical approach.

Although we lack reliable methods to differentiate fibroids from leiomyosarcomas, there are other malignant conditions of the uterus, as Dr. Bradley pointed out. Premalignant conditions of the uterus and cervix and endometrial adenocarcinomas occur far more frequently in the population than sarcomas, and we may be increasing risks by morcellating unsuspected cancers of any type.

At this time, whenever I am considering morcellation in any patient, I obtain pelvic imaging, endometrial biopsy, and current cervical cancer screening. If any of these studies suggest a malignant or premalignant condition, I avoid morcellation. Similarly, if a patient’s clinical history raises suspicion of a potential underlying malignant process, such as new symptoms of an enlarging myoma in a postmenopausal woman, I will try to find an alternative to morcellation.

Why we need a national surgery registry
The controversy surrounding open power morcellation was precipitated by the reporting of a single case—that of a prominent physician who had an unsuspected cancer morcellated during the course of a hysterectomy and was later upgraded to Stage 4 leiomyosarcoma as a result. But it wasn’t a gynecologic surgeon who reported the case—it was the patient herself. And we all know she was by no means the first case of an inadvertently morcellated sarcoma.

I would wager that few physicians are well versed in how to contact the FDA’s Manufacturer and User Facility Device Experience (MAUDE) database. And not many are familiar with the other specialized registries in the United States, let alone know how to report to them. Another important but often unaddressed issue: Is it hassle-free to make a report? The answer: A resounding “No.”

Who do we inform about our experiences—successful or not—in the operating room? And who pays for data collection? At present, the system is piecemeal or scattershot at best.

Sorely needed is a system for reporting that is easy to use, broad, and deep. A nationally funded system would be best. Otherwise, who is going to maintain the database? Who will filter the data? Who will ensure that the information that is entered is correct so that outcomes can be followed accurately?

For those of us employed by a hospital or other institution, it tends to be the institution itself that gathers the data—when it is gathered. But what about surgeons in private practice? How do they monitor themselves? And what about privately owned outpatient surgery centers, where patients sojourn no longer than 23 hours? Is it reasonable to expect them to add the burden and expense of data collection without a national mandate?

I know firsthand some of the skewed information that results when reporting is piecemeal or manipulated. When I was a resident, for example, in some localities, it was not uncommon for sexually transmitted diseases to go unreported when the patient had private insurance. The result: Only those in the lower socioeconomic ranks appeared to experience this problem.

Clearly, we need national standards and a national protocol. And to achieve that we need leaders strong enough to argue that the expense represents dollars well spent.
                                                                                                                                                  - Linda D. Bradley, MD                                                                                                    

Quick Poll:
If you are using, plan to use, or anticipate the possibility of using power morcellation during minimally invasive gynecologic surgery, does your consent process include a separate form specific to power morcellation?
Please provide your answer to this question in the Quick Poll on the OBG Management home page and then see how your peers have voted.

Share your thoughts on this article! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

The world of minimally invasive gynecologic surgery has been transformed over the past 10 months—specifically in regard to the option of open power morcellation. From individual hospital bans of the procedure to an official warning from the US Food and Drug Administration (FDA)¹ and the potential for further government action, the change has been swift and certain. ­Johnson & Johnson has recalled all power morcellators, many institutions now have bans in place, and one major insurer has announced its plan to discontinue coverage of power morcellation in three states.

What effect have these actions had on the availability of minimally invasive approaches to benign hysterectomy and myomectomy? And given new information on the risk of occult malignancy during these surgeries, how has patient selection and preoperative assessment changed? To address these and other questions, OBG ­ Management convened a panel of experts in minimally invasive gynecology and asked them to share their perspective. In this case-based discussion, they offer their views on the morcellation controversy and their current approach to hysterectomy, myomectomy, and tissue extraction. Next month, in Part 2 of their discussion, they address patient counseling and FDA actions.

What is your preferred approach?

OBG Management: In light of the morcellation controversy, what is your preferred approach for benign hysterectomy?

Kimberly Kho, MD, MPH: Whenever possible and appropriate, vaginal hysterectomy is my preferred route. However, many surgical cases require evaluation of the abdominal cavity for pain, endometriosis, or a concerning adnexal mass. In such cases, and in cases involving a very large uterus, I prefer laparoscopic hysterectomy—either laparoscopic-assisted vaginal hysterectomy or total laparoscopic hysterectomy (TLH). I tend to perform TLH more frequently in these cases if the uterus lacks descent or the patient’s anatomy restricts vaginal access. Even in these cases, and with very large myomas and uteri, I have been successful removing the uterus vaginally, although this approach frequently involves vaginal morcellation with a scalpel.

Arnold P. Advincula, MD: My preferred approach for both benign hysterectomy and myomectomy is robot-assisted laparoscopy. I have used this approach over the past 13 years. In my hands, it is reproducible, safe, efficient, and cost-effective and affords me the ability to tackle a wide range of complex cases.

Cheryl Iglesia, MD: Like Dr. Kho, I prefer vaginal hysterectomy.

Jason D. Wright, MD: I also prefer the vaginal approach. In fact, I believe it should be the preferred approach for hysterectomy for benign gynecologic disease whenever it is feasible. And the laparoscopic and robot-assisted approaches carry less perioperative morbidity than abdominal hysterectomy.

Given the recent concerns about open power morcellation, I prefer to perform either vaginal hysterectomy or minimally invasive hysterectomy without morcellation. If neither approach is feasible, given anatomic considerations, I counsel the patient about the risks and benefits of abdominal hysterectomy, compared with minimally invasive hysterectomy with morcellation.

Linda D. Bradley, MD: For women who meet minimally invasive surgical criteria, I prefer the laparoscopic approach because of its many benefits, including a shorter hospital stay (which reduces the risk of ­hospital-acquired infection and iatrogenic complications of hospitalization), lower risk of incisional infection, lower requirement for pain medications, and faster return to work.

OBG Management: What about myomectomy? Would your approach be different?

Dr. Bradley: Many myomectomy cases can be done hysteroscopically. I would like to point out, however, that when we talk about hysteroscopy, the morcellation issue is moot. Although there are hysteroscopic surgical devices that have used the word “morcellator” in their names, hysteroscopic morcellation is performed within a closed system—the uterine cavity—and so carries none of the risks of laparoscopic morcellation.

I prefer to perform nonhysteroscopic cases using a laparoscopic approach, creating a small mini-laparotomy to remove the fibroid intact or using a knife to morcellate the tissue outside of the peritoneal cavity.

Dr. Kho: I use a similar laparoscopic approach for myomectomy, using laparoscopy to assess the uterus and fibroids, enucleate the fibroid and remove it from the uterus, and then creating a mini-laparotomy incision
3 cm to 4 cm in length to manually remove or morcellate the fibroid and reapproximate the myometrium.

Dr. Iglesia: I rarely perform myomectomy but would likely do it laparoscopically or robotically to achieve minimally invasive benefits such as fewer adhesions and less postoperative pain.

How do you manage tissue extraction?

OBG Management: What methods of tissue extraction do you currently use during hysterectomy and myomectomy?

Dr. Advincula: I currently utilize a contained, extracorporeal, transumbilical, manual ­scalpel-morcellation technique for all myomectomy cases, as well as hysterectomy cases not amenable to transvaginal extraction.

Dr. Iglesia: I rely on vaginal removal of tissue and vaginal morcellation.

Dr. Kho: I infrequently perform supracervical hysterectomy, so almost all the hysterectomies I do are total hysterectomies. I remove the uterus through the vagina. In addition, because the size of the specimen frequently is too large to remove through a colpotomy intact, I morcellate the uterus manually with a scalpel using coring, wedge resection, and myomectomy. I find this to be an efficient and controlled method for tissue removal, with minimal tissue scattering. I also have begun to perform the same type of vaginal morcellation with the specimen enclosed in a bag.

That being said, the spread of occult malignancy has been reported after all types of morcellation—not just with power morcellation but also with vaginal and abdominal morcellation. So we are increasingly performing tissue extraction in an enclosed fashion using manual morcellation in a containment bag through a mini-laparotomy or posterior colpotomy to minimize the risk of leaving tissue fragments behind.

Dr. Wright: Although different methods of tissue extraction, including morcellation within a bag, are commonly discussed, data documenting the safety of these methods are extremely limited and patients should be counseled accordingly.

Similarly, the risk of adverse pathology increases substantially with age, and morcellation should be considered with great caution—if at all—in older women.

Given the risks associated with power morcellation, I try to avoid uterine disruption at the time of hysterectomy and perform either vaginal or minimally invasive total hysterectomy. In older women, because of the higher risk of underlying pathology, I prefer laparotomy if anatomic considerations preclude a vaginal or minimally invasive total hysterectomy. Younger women can be counseled about the risks and benefits of various routes of extraction. Patients with any suspicious findings during preoperative evaluation or surgery itself should have their uterus removed without disruption or fragmentation.

In regard to myomectomy specifically, a significant portion of the data we have on the risks of power morcellation derives from studies of hysterectomy. There are minimal data describing the risk of occult pathology at the time of minimally invasive myomectomy. Although younger patients likely are at relatively low risk for occult malignancy, they should be counseled that population-based estimates of cancer at the time of myomectomy are lacking.

Dr. Bradley: Since the controversy over morcellation arose, the Cleveland Clinic not only has banned the procedure but also removed all morcellators from its shelves, and it is unclear whether the option will be revisited after the FDA renders its final verdict. So my approach to tissue extraction is either vaginal morcellation or using a mini-laparotomy to remove the whole specimen intact or put it in a bag and morcellate it with a knife.

Case 1: A premenopausal patient scheduled for myomectomy

OBG Management: Let’s move on to a specific case. Let’s say the patient is a 35-year-old woman with a large fibroid, to be removed by myomectomy. How would you quantify her risk of occult malignancy? And what would preoperative assessment entail?

Dr. Iglesia: This patient’s risk of occult malignancy is low. I would obtain pelvic ultrasonography and endometrial biopsy, with cervical cytology included. Preoperative magnetic resonance imaging (MRI) would be indicated if there is a possibility that power morcellation will be performed. If power morcellation were selected, I would perform it using a bag.

Dr. Bradley: At the Cleveland Clinic, we now utilize the FDA risk estimates for occult malignancy of 1 in 300 to 1 in 350 women,¹ and I counsel patients using these figures. In the past several years, we have begun to use MRI with and without contrast to determine the size, number, and location of the fibroids, to determine our surgical approach, and to guide our discussion with the patient of what we will be able to do—for example, laparoscopy versus laparotomy.

OBG Management: Would the FDA figures you give be applicable to a young woman such as this 35-year-old?

Dr. Bradley: We’re using those figures with all of our premenopausal patients.

OBG Management: And does the MRI pick up sarcomas?

Dr. Bradley: No imaging is 100% sensitive in detecting sarcoma. We do MRI, and if the fibroid has any areas of necrosis, irregularity, or poor tissue planes that would arouse our suspicion of adenomyoma or sarcoma, we perform the myomectomy via laparotomy. But as I mentioned earlier, we don’t use power morcellation at all anymore—so this patient you describe would likely undergo laparoscopic removal using a bag and a knife to extract it to the skin level.

Although every patient is different, in general, if we have a patient with a single large fibroid 10 cm or less in size, we try to remove it laparoscopically or with robot ­assistance rather than via laparotomy. We also perform endometrial biopsy.

Dr. Advincula: First, it’s important to define prevalence and incidence when discussing risks. Prevalence would be the number of patients with a leiomyosarcoma per 100,000 women, whereas incidence is the number of patients given a diagnosis of leiomyosarcoma within a year per 100,000 women. In this case, a 35-year-old woman would have a prevalence of leiomyosarcoma, in the general population, of 3 to 7 per 100,000 women and an incidence of less than 1%.

My preoperative assessment would involve MRI of the pelvis with T2 weighted images to better characterize her uterus. Although there has been much discussion lately about the use of lactate dehydrogenase (LDH) isoenzyme panels in combination with MRI to detect occult leiomyosarcoma, the reliability and reproducibility of that combined approach are not fully vetted and, as yet, are not a standard part of my workup. Endometrial sampling would certainly be warranted with any associated history of abnormal uterine bleeding.

Dr. Wright: As I mentioned earlier, most data on power morcellation have been derived from studies of women undergoing hysterectomy. To date, accurate estimates to predict the risk of occult cancer in this patient planning to undergo myomectomy are largely lacking. For women undergoing hysterectomy using power morcellation, advanced age is the strongest risk factor for occult malignancy. Although this patient’s risk of cancer likely is relatively low, she should be counseled that precise estimates are lacking.

Preoperatively, she should undergo endometrial sampling if she has abnormal bleeding. However, the reliability of endometrial sampling, as well as imaging, is limited in the detection of uterine sarcomas.

Case 2: Perimenopausal patient undergoing hysterectomy

OBG Management: How would your approach to preoperative assessment change if this patient were a 47-year-old ­perimenopausal woman with a single large fibroid to be removed by hysterectomy?

Dr. Bradley: It would be the same preoperative assessment—an MRI and an endometrial biopsy.

Dr. Iglesia: The risk of occult malignancy would be greater than with the first patient. Again, I would use pelvic ultrasound, endometrial biopsy, and cervical cytology to assess her, and I would perform vaginal or TLH. MRI would be indicated if there is a possibility of performing intraperitoneal morcellation. I would prefer doing any morcellation in a bag or via laparotomy.

Dr. Wright: Based on age alone, this perimenopausal patient’s risk for an underlying cancer is 0.2%.² If the patient has any abnormal bleeding, she should undergo endometrial sampling preoperatively. The diagnostic modalities currently available—which include endometrial sampling as well as imaging, even MRI—are unreliable in the diagnosis of uterine sarcomas, and the patient should be counseled accordingly if she is considering power morcellation.

If it is technically feasible, vaginal hysterectomy or a minimally invasive hysterectomy without power morcellation are preferred. If neither modality is feasible and the patient is considering power morcellation, she should be carefully counseled about the underlying risk not only of uterine cancer but also of other adverse pathologic abnormalities.

Case 3: Postmenopausal woman scheduled for hysterectomy

OBG Management: Let’s change the details of the case again. This time she’s 55 years old and postmenopausal. She, too, has a large fibroid to be removed via hysterectomy. What is her risk of occult cancer? How would you assess her preoperatively?

Dr. Bradley: My approach would be the same as in the first two cases. However, because this patient is menopausal, morcellation would be off the table. (And it already is off the table—for any patient—at the ­Cleveland Clinic.) I usually prefer open hysterectomy for these patients, which is very different from what we were doing 1 year ago.

I want to expand on Dr. Wright’s comments about other pathologic abnormalities. As a woman ages, her cancer risk becomes greatest for malignancy of the endometrium rather than cancer in a fibroid. If this were my 55-year-old patient, and I had been seeing her for 20 years, and her fibroids had remained the same size but she was now having bleeding, I’d be more concerned about an endometrial problem—hyperplasia, a polyp, or cancer.

If the patient were having bulk symptoms, new pain, and imaging that shows, over 10 years between perimenopause and postmenopause, that there has been growth of the fibroids, I would be concerned about a sarcoma.

Some women who present with postmenopausal bleeding have ovarian cancer, and some studies show that a significant percentage of women with ovarian cancer present with bleeding as a primary symptom.³ So in a postmenopausal patient, I really want to know about the health of the ovaries. Are they enlarged on imaging?

There is also a bimodal distribution of human papillomavirus (HPV) infection and cervical cancer, with peaks of infection at ages 26 to 30 years and again at 46 to 50 years in some populations. The second age peak is followed by an increase in cervical intraepithelial neoplasia (CIN) 2 and 3 and invasive cervical cancer 20 years later.⁴ So I also want to consider the possibility of cervical cancer in this population.

I tell my patients that pretty much everybody has fibroids. Because they are so common, I need to look at the whole picture.

Dr. Wright: For the perimenopausal and postmenopausal patients we are discussing, preoperative evaluation and counseling would be similar to that for the premenopausal woman. However, given recent data, it is important to note that the prevalence ratio for a uterine malignancy increases with increasing age.² Clinicians need to be mindful of red flags in perimenopausal and postmenopausal women.

Dr. Kho: I agree that, for each of the cases we have discussed, we need to consider more than just the presence of the fibroid. Risk stratification based on clinical factors like age, menopausal status, BMI, the indication for surgery, and response to any other therapy is extremely important and should guide decision-making regarding the surgical approach.

Although we lack reliable methods to differentiate fibroids from leiomyosarcomas, there are other malignant conditions of the uterus, as Dr. Bradley pointed out. Premalignant conditions of the uterus and cervix and endometrial adenocarcinomas occur far more frequently in the population than sarcomas, and we may be increasing risks by morcellating unsuspected cancers of any type.

At this time, whenever I am considering morcellation in any patient, I obtain pelvic imaging, endometrial biopsy, and current cervical cancer screening. If any of these studies suggest a malignant or premalignant condition, I avoid morcellation. Similarly, if a patient’s clinical history raises suspicion of a potential underlying malignant process, such as new symptoms of an enlarging myoma in a postmenopausal woman, I will try to find an alternative to morcellation.

Why we need a national surgery registry
The controversy surrounding open power morcellation was precipitated by the reporting of a single case—that of a prominent physician who had an unsuspected cancer morcellated during the course of a hysterectomy and was later upgraded to Stage 4 leiomyosarcoma as a result. But it wasn’t a gynecologic surgeon who reported the case—it was the patient herself. And we all know she was by no means the first case of an inadvertently morcellated sarcoma.

I would wager that few physicians are well versed in how to contact the FDA’s Manufacturer and User Facility Device Experience (MAUDE) database. And not many are familiar with the other specialized registries in the United States, let alone know how to report to them. Another important but often unaddressed issue: Is it hassle-free to make a report? The answer: A resounding “No.”

Who do we inform about our experiences—successful or not—in the operating room? And who pays for data collection? At present, the system is piecemeal or scattershot at best.

Sorely needed is a system for reporting that is easy to use, broad, and deep. A nationally funded system would be best. Otherwise, who is going to maintain the database? Who will filter the data? Who will ensure that the information that is entered is correct so that outcomes can be followed accurately?

For those of us employed by a hospital or other institution, it tends to be the institution itself that gathers the data—when it is gathered. But what about surgeons in private practice? How do they monitor themselves? And what about privately owned outpatient surgery centers, where patients sojourn no longer than 23 hours? Is it reasonable to expect them to add the burden and expense of data collection without a national mandate?

I know firsthand some of the skewed information that results when reporting is piecemeal or manipulated. When I was a resident, for example, in some localities, it was not uncommon for sexually transmitted diseases to go unreported when the patient had private insurance. The result: Only those in the lower socioeconomic ranks appeared to experience this problem.

Clearly, we need national standards and a national protocol. And to achieve that we need leaders strong enough to argue that the expense represents dollars well spent.
                                                                                                                                                  - Linda D. Bradley, MD                                                                                                    

Quick Poll:
If you are using, plan to use, or anticipate the possibility of using power morcellation during minimally invasive gynecologic surgery, does your consent process include a separate form specific to power morcellation?
Please provide your answer to this question in the Quick Poll on the OBG Management home page and then see how your peers have voted.

Share your thoughts on this article! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

Since the last installment of this Update on Sexual Dysfunction, three new drugs have been added to the armamentarium for menopausal symptoms and dyspareunia:

• paroxetine 7.5 mg (Brisdelle)
• conjugated estrogens and bazedoxifene (Duavee)
• ospemifene (Osphena).

In this article, I present a case-based approach to incorporating these drugs into practice and restoring sexual function in the setting of vulvovaginal atrophy and dyspareunia. As is often the case, decision-making requires sifting through multiple layers of information.

How to “tease out” the problem and help the patient regain sexual function

Simon JA, Portman DJ, Kazempour K, Mekonnen H, Bhaskar S, Lippman J. Safety profile of paroxetine 7.5 mg in women with moderate-to-severe vasomotor symptoms. Obstet Gynecol. 2014;123(suppl 1):132S–133S.

Conjugated estrogens/bazedoxifene (Duavee) for menopausal symptoms and prevention of osteoporosis. Med Lett Drugs Ther. 2014;56(1441):33–34.

DeGregorio MW, Zerbe RL, Wurz GT. Ospemifene: a first-in-class, non-hormonal selective estrogen receptor modulator approved for the treatment of dyspareunia associated with vulvar and vaginal atrophy [published online ahead of print August 1, 2014]. Steroids. doi:10.1016/j.steroids.2014.07.012.

Goldstein SR, Archer DF, Simon JA, Constantine G. Endometrial safety of ospemifene and the ability of transvaginal ultrasonography to detect small changes in endometrial thickness. Obstet Gynecol. 2014;123(suppl 1):96S–97S.

CASE: LOW DESIRE AND DISCOMFORT DURING INTERCOURSE
Your 58-year-old patient, G2P2, mentions during her annual visit that she’s not that interested in sex anymore. Her children are grown, she’s been happily married for 28 years, and she enjoys her job and denies any symptoms of depression. She says her relationship with her husband is good and, aside from her low desire, she has no worries about the marriage. Her only medication is paroxetine 7.5 mg/day (Brisdelle) for management of her moderate hot flashes, which she initiated at her last annual visit. She reports improvement in her sleep and menopausal symptoms as a result. She has an intact uterus.

You perform a pelvic exam and find atrophic vulva and vagina with mild erythema, and thinned epithelium. When you ask if she has experienced any discomfort, she reports that she needs to use lubrication for intercourse and that, even with lubrication, she has pain upon penetration and a burning sensation that continues throughout intercourse. She also reports that it seems to take her much longer to achieve arousal than in the past, and she often fails to reach orgasm.

How would you manage this patient?

As always, begin with the history
The transition to menopause creates multiple layers of potential symptoms and problems for our patients, and sometimes medical therapy can generate additional ones.

In a patient reporting the onset of low desire and dyspareunia, you would want to first consider her medication history, despite the clear evidence of vaginal atrophy. Begin by asking whether she is taking any new medications prescribed by another provider. In some cases, antihypertensive drugs, psychotropic agents, and other medications can affect sexual function.

This patient has been taking Brisdelle for 1 year and is happy with its effect on her sleep and hot flashes. Simon and colleagues found this nonhormonal agent for moderate to severe vasomotor symptoms to produce no notable effects in weight, libido, or sleep, compared with placebo.

Nevertheless, in this case, because selective serotonin reuptake inhibitors (SSRIs) such as paroxetine can affect arousal and orgasm, it is unclear whether the ultra-low dose of paroxetine she is taking is contributing to her problems. If you were to discontinue the drug to find out, her vasomotor symptoms and sleep disruption would likely recur.

Your decision-making is important here and should involve the patient in an extensive discussion. If there is not enough time for this discussion at the current visit, schedule a follow-up to address her issues fully.

Vulvovaginal atrophy has its own timeline
In many cases, vasomotor symptoms such as hot flashes occur years before the skin begins to atrophy in the vulva and vagina, particularly in women who enter menopause naturally. Among menopausal women who continue to have intercourse on a regular basis, however, these skin changes often are much less troublesome than they are for women who have sex more rarely.

In this patient, one possible scenario is that paroxetine caused a slight reduction in sexual interest, and the frequency of intercourse went down as a result. In women who have little or no intercourse, the vagina begins to shrink and the tissues lose elasticity. This patient may have been undergoing the natural process of menopause, and that process may have been compounded by a decrease in the frequency of sex.

If you were to discontinue the paroxetine, it would still be necessary to treat the vulvovaginal skin and work on manual techniques to gently dilate the introitus.

Option 1: Systemic hormone therapy
Systemic estrogen is the most effective treatment for menopausal vasomotor symptoms, reducing hot flashes by 50% to 100% within 4 weeks of initiation. However, because our patient has an intact uterus, any systemic estrogen she opts to use must be opposed by a progestin for safety reasons.

In terms of estrogen, her options are oral or nonoral formulations. Not only would estrogen manage our patient’s hot flashes but, over time, it would improve her sexual problems and atrophy, which might or might not improve her current complaint of low desire. You likely would need to add a short regimen of topical estrogen and perhaps even a dilator to restore her sexual function completely, however.

Since our patient chose the nonhormonal agent Brisdelle to manage her menopausal symptoms, she may be worried about the increased risk of breast cancer associated with use of a progestin in combination with estrogen. One hormonal option now available that eliminates the need for a progestin is conjugated estrogens and bazedoxefine (Duavee). Bazedoxefine is a third-
generation selective estrogen receptor modulator (SERM). This drug has estrogen-like effects on bone and antiestrogen effects on the uterus.

Duavee is indicated for use in women with a uterus for treatment of:

• moderate to severe vasomotor symptoms of menopause
• prevention of postmenopausal osteoporosis.

Among the risks are an increased risk of venous thromboembolism (VTE) and stroke. It is not approved specifically for the treatment of dyspareunia.

Another hormonal option is ospemifene (Osphena), an estrogen agonist/antagonist indicated for the treatment of moderate to severe dyspareunia in menopausal women. Among the drugs in its class, such as tamoxifen and raloxifene, ospemifene is the only agent that maintains a full estrogenic effect on vaginal tissues. Its risks include VTE and stroke.

Although the labeling includes a warning about the risk of endometrial hyperplasia associated with its use, Goldstein and colleagues found no significant difference in the rate of endometrial thickening greater than 5 mm between women taking ospemifene and those taking placebo after 1 year of daily oral treatment. No carcinomas were found in either group.

Option 2: Local estrogen
If our patient declines all systemic hormone therapy, the topical approach should resolve her vulvovaginal symptoms, and she could continue taking Brisdelle for her menopausal symptoms. Vaginal estrogen would address the skin problems, provided the patient applies it correctly. Many women are afraid to use estrogen creams and compensate by applying them only to the vulva, thinking that, by limiting their use to external tissues, they are avoiding any associated risks.

If she opts for the local approach, this patient should be encouraged to use transvaginal estrogen in small doses to increase the elasticity of the vulvovaginal tissue, even though it may require daily use for a week or two to improve her symptoms, after which once- or twice-weekly administration should suffice.

The use of low-dose vaginal cream for a short duration is unlikely to increase her risks in any way.

Local estrogen is available as a tablet, cream, or ring.

Option 3: A nonhormonal approach
If the patient refuses any hormonal agent—even topical estrogen—I would recommend the use of silicone-based lubricants and a dilator and prescribe more frequent penetration to increase elasticity and reduce pain.

Brisdelle could be continued to address her menopausal symptoms.

Don’t overlook behavioral techniques
Before this patient leaves your office with the option of her choice, a bit of counseling is necessary to instruct her about methods of restoring full sexual function.

Pain is a powerful aversive stimulus. This patient clearly states that she has had less frequent intercourse as a result of dyspareunia. It is not unusual for patients to develop a “habit” of avoidance in response to the behavior that causes their pain.

One recommendation is to talk to this patient about putting sex back into her life by encouraging her to increase sexual activity without penetration until she begins to arouse easily again. Arousal produces physiologic effects, increasing the caliber and length of the vagina as well as lubrication. The use of fingers or dilators may help restore caliber.

The patient can be encouraged to engage in snuggling and cuddling to regain those activities without the fear of pain associated with penetration. Follow-up after 2 weeks of this therapy can confirm the restoration of tissue elasticity, and the green light can be given for penetration to begin again. Couples can be encouraged to plan a “honeymoon weekend” and put some fun back into their sex lives so that this phase of healing doesn’t become an onerous task.

CASE RESOLVED After a discussion of her options, the patient chooses to stick with Brisdelle and use behavioral therapy alone to resolve her dyspareunia. At her follow-up visit 2 weeks later, she reports that she has enjoyed the period of pain-free “sex” and feels ready to add penetration into her activities.

You encourage her to continue sexual intercourse on a regular, relatively frequent basis to prevent a recurrence of dyspareunia. She continues to use silicone-based lubricants.

Share your thoughts on this article! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

Since the last installment of this Update on Sexual Dysfunction, three new drugs have been added to the armamentarium for menopausal symptoms and dyspareunia:

• paroxetine 7.5 mg (Brisdelle)
• conjugated estrogens and bazedoxifene (Duavee)
• ospemifene (Osphena).

In this article, I present a case-based approach to incorporating these drugs into practice and restoring sexual function in the setting of vulvovaginal atrophy and dyspareunia. As is often the case, decision-making requires sifting through multiple layers of information.

How to “tease out” the problem and help the patient regain sexual function

Simon JA, Portman DJ, Kazempour K, Mekonnen H, Bhaskar S, Lippman J. Safety profile of paroxetine 7.5 mg in women with moderate-to-severe vasomotor symptoms. Obstet Gynecol. 2014;123(suppl 1):132S–133S.

Conjugated estrogens/bazedoxifene (Duavee) for menopausal symptoms and prevention of osteoporosis. Med Lett Drugs Ther. 2014;56(1441):33–34.

DeGregorio MW, Zerbe RL, Wurz GT. Ospemifene: a first-in-class, non-hormonal selective estrogen receptor modulator approved for the treatment of dyspareunia associated with vulvar and vaginal atrophy [published online ahead of print August 1, 2014]. Steroids. doi:10.1016/j.steroids.2014.07.012.

Goldstein SR, Archer DF, Simon JA, Constantine G. Endometrial safety of ospemifene and the ability of transvaginal ultrasonography to detect small changes in endometrial thickness. Obstet Gynecol. 2014;123(suppl 1):96S–97S.

CASE: LOW DESIRE AND DISCOMFORT DURING INTERCOURSE
Your 58-year-old patient, G2P2, mentions during her annual visit that she’s not that interested in sex anymore. Her children are grown, she’s been happily married for 28 years, and she enjoys her job and denies any symptoms of depression. She says her relationship with her husband is good and, aside from her low desire, she has no worries about the marriage. Her only medication is paroxetine 7.5 mg/day (Brisdelle) for management of her moderate hot flashes, which she initiated at her last annual visit. She reports improvement in her sleep and menopausal symptoms as a result. She has an intact uterus.

You perform a pelvic exam and find atrophic vulva and vagina with mild erythema, and thinned epithelium. When you ask if she has experienced any discomfort, she reports that she needs to use lubrication for intercourse and that, even with lubrication, she has pain upon penetration and a burning sensation that continues throughout intercourse. She also reports that it seems to take her much longer to achieve arousal than in the past, and she often fails to reach orgasm.

How would you manage this patient?

As always, begin with the history
The transition to menopause creates multiple layers of potential symptoms and problems for our patients, and sometimes medical therapy can generate additional ones.

In a patient reporting the onset of low desire and dyspareunia, you would want to first consider her medication history, despite the clear evidence of vaginal atrophy. Begin by asking whether she is taking any new medications prescribed by another provider. In some cases, antihypertensive drugs, psychotropic agents, and other medications can affect sexual function.

This patient has been taking Brisdelle for 1 year and is happy with its effect on her sleep and hot flashes. Simon and colleagues found this nonhormonal agent for moderate to severe vasomotor symptoms to produce no notable effects in weight, libido, or sleep, compared with placebo.

Nevertheless, in this case, because selective serotonin reuptake inhibitors (SSRIs) such as paroxetine can affect arousal and orgasm, it is unclear whether the ultra-low dose of paroxetine she is taking is contributing to her problems. If you were to discontinue the drug to find out, her vasomotor symptoms and sleep disruption would likely recur.

Your decision-making is important here and should involve the patient in an extensive discussion. If there is not enough time for this discussion at the current visit, schedule a follow-up to address her issues fully.

Vulvovaginal atrophy has its own timeline
In many cases, vasomotor symptoms such as hot flashes occur years before the skin begins to atrophy in the vulva and vagina, particularly in women who enter menopause naturally. Among menopausal women who continue to have intercourse on a regular basis, however, these skin changes often are much less troublesome than they are for women who have sex more rarely.

In this patient, one possible scenario is that paroxetine caused a slight reduction in sexual interest, and the frequency of intercourse went down as a result. In women who have little or no intercourse, the vagina begins to shrink and the tissues lose elasticity. This patient may have been undergoing the natural process of menopause, and that process may have been compounded by a decrease in the frequency of sex.

If you were to discontinue the paroxetine, it would still be necessary to treat the vulvovaginal skin and work on manual techniques to gently dilate the introitus.

Option 1: Systemic hormone therapy
Systemic estrogen is the most effective treatment for menopausal vasomotor symptoms, reducing hot flashes by 50% to 100% within 4 weeks of initiation. However, because our patient has an intact uterus, any systemic estrogen she opts to use must be opposed by a progestin for safety reasons.

In terms of estrogen, her options are oral or nonoral formulations. Not only would estrogen manage our patient’s hot flashes but, over time, it would improve her sexual problems and atrophy, which might or might not improve her current complaint of low desire. You likely would need to add a short regimen of topical estrogen and perhaps even a dilator to restore her sexual function completely, however.

Since our patient chose the nonhormonal agent Brisdelle to manage her menopausal symptoms, she may be worried about the increased risk of breast cancer associated with use of a progestin in combination with estrogen. One hormonal option now available that eliminates the need for a progestin is conjugated estrogens and bazedoxefine (Duavee). Bazedoxefine is a third-
generation selective estrogen receptor modulator (SERM). This drug has estrogen-like effects on bone and antiestrogen effects on the uterus.

Duavee is indicated for use in women with a uterus for treatment of:

• moderate to severe vasomotor symptoms of menopause
• prevention of postmenopausal osteoporosis.

Among the risks are an increased risk of venous thromboembolism (VTE) and stroke. It is not approved specifically for the treatment of dyspareunia.

Another hormonal option is ospemifene (Osphena), an estrogen agonist/antagonist indicated for the treatment of moderate to severe dyspareunia in menopausal women. Among the drugs in its class, such as tamoxifen and raloxifene, ospemifene is the only agent that maintains a full estrogenic effect on vaginal tissues. Its risks include VTE and stroke.

Although the labeling includes a warning about the risk of endometrial hyperplasia associated with its use, Goldstein and colleagues found no significant difference in the rate of endometrial thickening greater than 5 mm between women taking ospemifene and those taking placebo after 1 year of daily oral treatment. No carcinomas were found in either group.

Option 2: Local estrogen
If our patient declines all systemic hormone therapy, the topical approach should resolve her vulvovaginal symptoms, and she could continue taking Brisdelle for her menopausal symptoms. Vaginal estrogen would address the skin problems, provided the patient applies it correctly. Many women are afraid to use estrogen creams and compensate by applying them only to the vulva, thinking that, by limiting their use to external tissues, they are avoiding any associated risks.

If she opts for the local approach, this patient should be encouraged to use transvaginal estrogen in small doses to increase the elasticity of the vulvovaginal tissue, even though it may require daily use for a week or two to improve her symptoms, after which once- or twice-weekly administration should suffice.

The use of low-dose vaginal cream for a short duration is unlikely to increase her risks in any way.

Local estrogen is available as a tablet, cream, or ring.

Option 3: A nonhormonal approach
If the patient refuses any hormonal agent—even topical estrogen—I would recommend the use of silicone-based lubricants and a dilator and prescribe more frequent penetration to increase elasticity and reduce pain.

Brisdelle could be continued to address her menopausal symptoms.

Don’t overlook behavioral techniques
Before this patient leaves your office with the option of her choice, a bit of counseling is necessary to instruct her about methods of restoring full sexual function.

Pain is a powerful aversive stimulus. This patient clearly states that she has had less frequent intercourse as a result of dyspareunia. It is not unusual for patients to develop a “habit” of avoidance in response to the behavior that causes their pain.

One recommendation is to talk to this patient about putting sex back into her life by encouraging her to increase sexual activity without penetration until she begins to arouse easily again. Arousal produces physiologic effects, increasing the caliber and length of the vagina as well as lubrication. The use of fingers or dilators may help restore caliber.

The patient can be encouraged to engage in snuggling and cuddling to regain those activities without the fear of pain associated with penetration. Follow-up after 2 weeks of this therapy can confirm the restoration of tissue elasticity, and the green light can be given for penetration to begin again. Couples can be encouraged to plan a “honeymoon weekend” and put some fun back into their sex lives so that this phase of healing doesn’t become an onerous task.

CASE RESOLVED After a discussion of her options, the patient chooses to stick with Brisdelle and use behavioral therapy alone to resolve her dyspareunia. At her follow-up visit 2 weeks later, she reports that she has enjoyed the period of pain-free “sex” and feels ready to add penetration into her activities.

You encourage her to continue sexual intercourse on a regular, relatively frequent basis to prevent a recurrence of dyspareunia. She continues to use silicone-based lubricants.

Share your thoughts on this article! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

Since the last installment of this Update on Sexual Dysfunction, three new drugs have been added to the armamentarium for menopausal symptoms and dyspareunia:

• paroxetine 7.5 mg (Brisdelle)
• conjugated estrogens and bazedoxifene (Duavee)
• ospemifene (Osphena).

In this article, I present a case-based approach to incorporating these drugs into practice and restoring sexual function in the setting of vulvovaginal atrophy and dyspareunia. As is often the case, decision-making requires sifting through multiple layers of information.

How to “tease out” the problem and help the patient regain sexual function

Simon JA, Portman DJ, Kazempour K, Mekonnen H, Bhaskar S, Lippman J. Safety profile of paroxetine 7.5 mg in women with moderate-to-severe vasomotor symptoms. Obstet Gynecol. 2014;123(suppl 1):132S–133S.

Conjugated estrogens/bazedoxifene (Duavee) for menopausal symptoms and prevention of osteoporosis. Med Lett Drugs Ther. 2014;56(1441):33–34.

DeGregorio MW, Zerbe RL, Wurz GT. Ospemifene: a first-in-class, non-hormonal selective estrogen receptor modulator approved for the treatment of dyspareunia associated with vulvar and vaginal atrophy [published online ahead of print August 1, 2014]. Steroids. doi:10.1016/j.steroids.2014.07.012.

Goldstein SR, Archer DF, Simon JA, Constantine G. Endometrial safety of ospemifene and the ability of transvaginal ultrasonography to detect small changes in endometrial thickness. Obstet Gynecol. 2014;123(suppl 1):96S–97S.

CASE: LOW DESIRE AND DISCOMFORT DURING INTERCOURSE
Your 58-year-old patient, G2P2, mentions during her annual visit that she’s not that interested in sex anymore. Her children are grown, she’s been happily married for 28 years, and she enjoys her job and denies any symptoms of depression. She says her relationship with her husband is good and, aside from her low desire, she has no worries about the marriage. Her only medication is paroxetine 7.5 mg/day (Brisdelle) for management of her moderate hot flashes, which she initiated at her last annual visit. She reports improvement in her sleep and menopausal symptoms as a result. She has an intact uterus.

You perform a pelvic exam and find atrophic vulva and vagina with mild erythema, and thinned epithelium. When you ask if she has experienced any discomfort, she reports that she needs to use lubrication for intercourse and that, even with lubrication, she has pain upon penetration and a burning sensation that continues throughout intercourse. She also reports that it seems to take her much longer to achieve arousal than in the past, and she often fails to reach orgasm.

How would you manage this patient?

As always, begin with the history
The transition to menopause creates multiple layers of potential symptoms and problems for our patients, and sometimes medical therapy can generate additional ones.

In a patient reporting the onset of low desire and dyspareunia, you would want to first consider her medication history, despite the clear evidence of vaginal atrophy. Begin by asking whether she is taking any new medications prescribed by another provider. In some cases, antihypertensive drugs, psychotropic agents, and other medications can affect sexual function.

This patient has been taking Brisdelle for 1 year and is happy with its effect on her sleep and hot flashes. Simon and colleagues found this nonhormonal agent for moderate to severe vasomotor symptoms to produce no notable effects in weight, libido, or sleep, compared with placebo.

Nevertheless, in this case, because selective serotonin reuptake inhibitors (SSRIs) such as paroxetine can affect arousal and orgasm, it is unclear whether the ultra-low dose of paroxetine she is taking is contributing to her problems. If you were to discontinue the drug to find out, her vasomotor symptoms and sleep disruption would likely recur.

Your decision-making is important here and should involve the patient in an extensive discussion. If there is not enough time for this discussion at the current visit, schedule a follow-up to address her issues fully.

Vulvovaginal atrophy has its own timeline
In many cases, vasomotor symptoms such as hot flashes occur years before the skin begins to atrophy in the vulva and vagina, particularly in women who enter menopause naturally. Among menopausal women who continue to have intercourse on a regular basis, however, these skin changes often are much less troublesome than they are for women who have sex more rarely.

In this patient, one possible scenario is that paroxetine caused a slight reduction in sexual interest, and the frequency of intercourse went down as a result. In women who have little or no intercourse, the vagina begins to shrink and the tissues lose elasticity. This patient may have been undergoing the natural process of menopause, and that process may have been compounded by a decrease in the frequency of sex.

If you were to discontinue the paroxetine, it would still be necessary to treat the vulvovaginal skin and work on manual techniques to gently dilate the introitus.

Option 1: Systemic hormone therapy
Systemic estrogen is the most effective treatment for menopausal vasomotor symptoms, reducing hot flashes by 50% to 100% within 4 weeks of initiation. However, because our patient has an intact uterus, any systemic estrogen she opts to use must be opposed by a progestin for safety reasons.

In terms of estrogen, her options are oral or nonoral formulations. Not only would estrogen manage our patient’s hot flashes but, over time, it would improve her sexual problems and atrophy, which might or might not improve her current complaint of low desire. You likely would need to add a short regimen of topical estrogen and perhaps even a dilator to restore her sexual function completely, however.

Since our patient chose the nonhormonal agent Brisdelle to manage her menopausal symptoms, she may be worried about the increased risk of breast cancer associated with use of a progestin in combination with estrogen. One hormonal option now available that eliminates the need for a progestin is conjugated estrogens and bazedoxefine (Duavee). Bazedoxefine is a third-
generation selective estrogen receptor modulator (SERM). This drug has estrogen-like effects on bone and antiestrogen effects on the uterus.

Duavee is indicated for use in women with a uterus for treatment of:

• moderate to severe vasomotor symptoms of menopause
• prevention of postmenopausal osteoporosis.

Among the risks are an increased risk of venous thromboembolism (VTE) and stroke. It is not approved specifically for the treatment of dyspareunia.

Another hormonal option is ospemifene (Osphena), an estrogen agonist/antagonist indicated for the treatment of moderate to severe dyspareunia in menopausal women. Among the drugs in its class, such as tamoxifen and raloxifene, ospemifene is the only agent that maintains a full estrogenic effect on vaginal tissues. Its risks include VTE and stroke.

Although the labeling includes a warning about the risk of endometrial hyperplasia associated with its use, Goldstein and colleagues found no significant difference in the rate of endometrial thickening greater than 5 mm between women taking ospemifene and those taking placebo after 1 year of daily oral treatment. No carcinomas were found in either group.

Option 2: Local estrogen
If our patient declines all systemic hormone therapy, the topical approach should resolve her vulvovaginal symptoms, and she could continue taking Brisdelle for her menopausal symptoms. Vaginal estrogen would address the skin problems, provided the patient applies it correctly. Many women are afraid to use estrogen creams and compensate by applying them only to the vulva, thinking that, by limiting their use to external tissues, they are avoiding any associated risks.

If she opts for the local approach, this patient should be encouraged to use transvaginal estrogen in small doses to increase the elasticity of the vulvovaginal tissue, even though it may require daily use for a week or two to improve her symptoms, after which once- or twice-weekly administration should suffice.

The use of low-dose vaginal cream for a short duration is unlikely to increase her risks in any way.

Local estrogen is available as a tablet, cream, or ring.

Option 3: A nonhormonal approach
If the patient refuses any hormonal agent—even topical estrogen—I would recommend the use of silicone-based lubricants and a dilator and prescribe more frequent penetration to increase elasticity and reduce pain.

Brisdelle could be continued to address her menopausal symptoms.

Don’t overlook behavioral techniques
Before this patient leaves your office with the option of her choice, a bit of counseling is necessary to instruct her about methods of restoring full sexual function.

Pain is a powerful aversive stimulus. This patient clearly states that she has had less frequent intercourse as a result of dyspareunia. It is not unusual for patients to develop a “habit” of avoidance in response to the behavior that causes their pain.

One recommendation is to talk to this patient about putting sex back into her life by encouraging her to increase sexual activity without penetration until she begins to arouse easily again. Arousal produces physiologic effects, increasing the caliber and length of the vagina as well as lubrication. The use of fingers or dilators may help restore caliber.

The patient can be encouraged to engage in snuggling and cuddling to regain those activities without the fear of pain associated with penetration. Follow-up after 2 weeks of this therapy can confirm the restoration of tissue elasticity, and the green light can be given for penetration to begin again. Couples can be encouraged to plan a “honeymoon weekend” and put some fun back into their sex lives so that this phase of healing doesn’t become an onerous task.

CASE RESOLVED After a discussion of her options, the patient chooses to stick with Brisdelle and use behavioral therapy alone to resolve her dyspareunia. At her follow-up visit 2 weeks later, she reports that she has enjoyed the period of pain-free “sex” and feels ready to add penetration into her activities.

You encourage her to continue sexual intercourse on a regular, relatively frequent basis to prevent a recurrence of dyspareunia. She continues to use silicone-based lubricants.

Share your thoughts on this article! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

It’s high time to go beyond relying on YellowPages.com to attract patients to your practice. According to research and analysis company BIA/Kelsey, “nearly all consumers (97%) now use online media to shop locally.”¹ Today’s patients are Internet savvy and expect their ObGyn not only to be a good physician who diagnoses and treats their conditions but also to demonstrate his or her electronic technical abilities, through online communication, a Web site, email newsletter outreach, and, yes, a social media presence.

Yet, being the best in your field or having an incredible Web site won’t matter if your existing patients and potential new patients can’t find you on the Internet. The solution? Get your Web site onto the first page of Google’s search results. Why? Google is still by far the dominant search engine in the United States, and it has the overwhelming ability to offer you an endless supply of patients. And can your practice survive without a steady flow of new patients?

Type a keyword into the Google search window and dozens, hundreds, or thousands of sites may become visible. Google lists 10 sites per page, however, and when was the last time you went to the second, third, or fourth results page looking for something? If your Web site does not appear on the first results page, you are essentially invisible. The good news is that you can easily and inexpensively reach the top of a search engine’s results page by knowing and applying best practices for effective search engine optimization (SEO; a free endeavor, although your time investment should considered) and/or utilizing a pay-per-click (PPC) service (for a fee that’s comparable to what you used to pay for your old Yellow Pages listing). In this article, we aim to provide to you the know-how to embark on these endeavors by defining SEO and PPC and relaying effective principles for marketing your practice to potential new patients.

What is SEO?

SEO refers to techniques that help your Web site rank higher in organic (natural) results, which helps your site, and you, become more visible to people who are seeking your services. Search engines specialize in offering Web surfers the best information about their search terms, or keywords. To do this, Google uses more than 200 different algorithms, some of which we know but most of which are not published.

The algorithms are used to determine where your Web site ranks according to a number of factors relevant to the content and set-up of each page of your Web site (on-page SEO) as well as everything you do outside of your Web site (off-page SEO) to enhance your SEO rankings. This relevance is calculated by looking at both on-page and off-page factors, including:

You have to work on both on-page and off-page factors many times a month to convince the search engines that you are a Web site worth visiting. Over time, your site will start to rise in the rankings and gain qualified traffic. Then you can concentrate on converting those Web site visitors to office-based patients.

A warning: If you use unethical tactics to get your Web site on the first page of the search results, Google will catch up to you—and your Web-site rankings will plummet.

Five important steps to increase SEO

There’s a system to reach the top of any search engine’s results page. The most important steps are to:

1 and 2. Keywords are key
Keywords are what an Internet surfer enters into a search function and what the search engine crawlers hunt for. The crawlers then direct the surfer to the Web site that is perceived as the best source of information.

Here are the most popular keywords used by potential patients looking for ­ObGyns: obstetrician, gynecologist, gynecology, vaginal discharge, vaginal dryness, breast self-exam, breast cancer screening, prolapsed bladder, pelvic pain, and adolescent gynecology. You also should include your city’s name as a keyword.

Use keywords in Web site coding and copy. Unless you are experienced in Web development, you’re better off hiring a professional who knows Internet coding to help you develop HTML meta tags, anchor text, a sitemap, etc. You easily can incorporate keywords in the copy on your Web site, but the keyword density should be no more than approximately 3% to 5% of the copy. (If it is more than 5%, it is considered “stuffing,” and not looked on kindly by Google.)

3. In-bound links: Who’s linking to you?
As the search engine crawlers scan Web pages for indexing, they also look for links from other Web sites. The greater number of quality in-bound links a Web site has, the stronger influence or authority it accrues.

In-bound links are weighted differently: a link from a highly authoritative Web site like NYTimes.com will give a Web site a bigger boost than a link from a small blog site. Links from high-ranking sites, such as city directories, hospitals, and online medical directories, improve your Web-site ranking. You should be submitting your Web site address and keyword description to these appropriate directories for in-bound links on a weekly or monthly basis.

4. Develop new content by blogging
Search engines place a high value on new content, and the easiest way to add new keyword-related content is to blog. Writing a 400-word keyword–relevant blog on a regular basis will provide the search engine crawlers with new content to graze.

As an added bonus, there are many medical ezines—small magazines and newsletters distributed by any electronic ­method—that regularly need content. Publication of your blog article will provide additional back-links to your Web site and improve your SEO rankings. This is your opportunity to go “viral,” have your material read by thousands, and increase visits to your Web site. When your name appears on multiple sites, you create the perception of demonstrating your expertise in various topics, techniques, and therapeutic options.

5. Search engines love social media
Newer technologies are given greater weight in determining Web page ranking. Start with blogging and then add Facebook, YouTube, and Twitter. Always remember to link from these sites with relevant keywords to the exact page on your site that contains the best information for those keywords.

Advertise your practice using PPC (Google AdWords)

Google, Yahoo, and other Internet portals make their money by selling advertisements on search-results pages. Both paid and organic listings appear on the search results pages, but they are displayed in different locations. On Google, PPC listings are found on the top and right side of each page under the header “Ads” (FIGURE 1). The organic or natural search (no payment required) is on the left below the ads.

On Google, the PPC function is called ­“AdWords” (http://www.google.com/adwords). On the AdWords page, a listing is found that offers how many times people type in certain words or phrases—keywords. Google AdWords allows the marketplace to bid on keywords; the higher the bid, the closer to the top position on the first page of the Google search results. Depending on monthly search volume, popularity, and competition, you can pay anywhere from pennies to $25 each time a Web surfer clicks on your ad. In FIGURE 2, you can see that a suggested bid for “Gynecologist Miami” is $2.96.

You must constantly monitor and manage your AdWords account. Test different landing pages, adjust your copy, and change offerings to make sure you are converting your paid traffic to patients. Otherwise, you can spend hundreds of dollars each month without achieving the desired outcome.

By doing your own research with Google AdWords’ keyword planner, you will see the variations of keywords that you can use in the copy of your Web site and related content for organic SE

Patient conversion: Your ultimate goal

Google is only one piece of the Internet marketing puzzle. Once you have invested in mastering the SEO rankings (by doing it yourself or by paying for professional help), it’s up to your Web site to convert the visitor to a paying patient. To maximize your return on investment (ROI), implement marketing strategies and a patient conversion system on your Web site. When a prospective patient lands there, you have less than 10 seconds to engage her. In Part 1of this series, we discuss features that will keep your visitor involved while she navigates the site and make it easy for her to make an appointment. Don’t lose her because she can’t find your contact information hidden at the bottom of the page.²

If you don’t want to spend the time and effort to do it yourself, outsourcing is a cost-effective solution, and a trackable and measurable way for you to calculate your ROI.

Bottom line: Be seen on the Internet. We are all connected to the Internet every waking moment. This is where we go for information; this is how we communicate with each other; and this is where we create relationships. If you want to build your practice, you have to be where your patient can find you—on the top of an Internet search results page.

Share your thoughts on this article! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

It’s high time to go beyond relying on YellowPages.com to attract patients to your practice. According to research and analysis company BIA/Kelsey, “nearly all consumers (97%) now use online media to shop locally.”¹ Today’s patients are Internet savvy and expect their ObGyn not only to be a good physician who diagnoses and treats their conditions but also to demonstrate his or her electronic technical abilities, through online communication, a Web site, email newsletter outreach, and, yes, a social media presence.

Yet, being the best in your field or having an incredible Web site won’t matter if your existing patients and potential new patients can’t find you on the Internet. The solution? Get your Web site onto the first page of Google’s search results. Why? Google is still by far the dominant search engine in the United States, and it has the overwhelming ability to offer you an endless supply of patients. And can your practice survive without a steady flow of new patients?

Type a keyword into the Google search window and dozens, hundreds, or thousands of sites may become visible. Google lists 10 sites per page, however, and when was the last time you went to the second, third, or fourth results page looking for something? If your Web site does not appear on the first results page, you are essentially invisible. The good news is that you can easily and inexpensively reach the top of a search engine’s results page by knowing and applying best practices for effective search engine optimization (SEO; a free endeavor, although your time investment should considered) and/or utilizing a pay-per-click (PPC) service (for a fee that’s comparable to what you used to pay for your old Yellow Pages listing). In this article, we aim to provide to you the know-how to embark on these endeavors by defining SEO and PPC and relaying effective principles for marketing your practice to potential new patients.

What is SEO?

SEO refers to techniques that help your Web site rank higher in organic (natural) results, which helps your site, and you, become more visible to people who are seeking your services. Search engines specialize in offering Web surfers the best information about their search terms, or keywords. To do this, Google uses more than 200 different algorithms, some of which we know but most of which are not published.

The algorithms are used to determine where your Web site ranks according to a number of factors relevant to the content and set-up of each page of your Web site (on-page SEO) as well as everything you do outside of your Web site (off-page SEO) to enhance your SEO rankings. This relevance is calculated by looking at both on-page and off-page factors, including:

You have to work on both on-page and off-page factors many times a month to convince the search engines that you are a Web site worth visiting. Over time, your site will start to rise in the rankings and gain qualified traffic. Then you can concentrate on converting those Web site visitors to office-based patients.

A warning: If you use unethical tactics to get your Web site on the first page of the search results, Google will catch up to you—and your Web-site rankings will plummet.

Five important steps to increase SEO

There’s a system to reach the top of any search engine’s results page. The most important steps are to:

1 and 2. Keywords are key
Keywords are what an Internet surfer enters into a search function and what the search engine crawlers hunt for. The crawlers then direct the surfer to the Web site that is perceived as the best source of information.

Here are the most popular keywords used by potential patients looking for ­ObGyns: obstetrician, gynecologist, gynecology, vaginal discharge, vaginal dryness, breast self-exam, breast cancer screening, prolapsed bladder, pelvic pain, and adolescent gynecology. You also should include your city’s name as a keyword.

Use keywords in Web site coding and copy. Unless you are experienced in Web development, you’re better off hiring a professional who knows Internet coding to help you develop HTML meta tags, anchor text, a sitemap, etc. You easily can incorporate keywords in the copy on your Web site, but the keyword density should be no more than approximately 3% to 5% of the copy. (If it is more than 5%, it is considered “stuffing,” and not looked on kindly by Google.)

3. In-bound links: Who’s linking to you?
As the search engine crawlers scan Web pages for indexing, they also look for links from other Web sites. The greater number of quality in-bound links a Web site has, the stronger influence or authority it accrues.

In-bound links are weighted differently: a link from a highly authoritative Web site like NYTimes.com will give a Web site a bigger boost than a link from a small blog site. Links from high-ranking sites, such as city directories, hospitals, and online medical directories, improve your Web-site ranking. You should be submitting your Web site address and keyword description to these appropriate directories for in-bound links on a weekly or monthly basis.

4. Develop new content by blogging
Search engines place a high value on new content, and the easiest way to add new keyword-related content is to blog. Writing a 400-word keyword–relevant blog on a regular basis will provide the search engine crawlers with new content to graze.

As an added bonus, there are many medical ezines—small magazines and newsletters distributed by any electronic ­method—that regularly need content. Publication of your blog article will provide additional back-links to your Web site and improve your SEO rankings. This is your opportunity to go “viral,” have your material read by thousands, and increase visits to your Web site. When your name appears on multiple sites, you create the perception of demonstrating your expertise in various topics, techniques, and therapeutic options.

5. Search engines love social media
Newer technologies are given greater weight in determining Web page ranking. Start with blogging and then add Facebook, YouTube, and Twitter. Always remember to link from these sites with relevant keywords to the exact page on your site that contains the best information for those keywords.

Advertise your practice using PPC (Google AdWords)

Google, Yahoo, and other Internet portals make their money by selling advertisements on search-results pages. Both paid and organic listings appear on the search results pages, but they are displayed in different locations. On Google, PPC listings are found on the top and right side of each page under the header “Ads” (FIGURE 1). The organic or natural search (no payment required) is on the left below the ads.

On Google, the PPC function is called ­“AdWords” (http://www.google.com/adwords). On the AdWords page, a listing is found that offers how many times people type in certain words or phrases—keywords. Google AdWords allows the marketplace to bid on keywords; the higher the bid, the closer to the top position on the first page of the Google search results. Depending on monthly search volume, popularity, and competition, you can pay anywhere from pennies to $25 each time a Web surfer clicks on your ad. In FIGURE 2, you can see that a suggested bid for “Gynecologist Miami” is $2.96.

You must constantly monitor and manage your AdWords account. Test different landing pages, adjust your copy, and change offerings to make sure you are converting your paid traffic to patients. Otherwise, you can spend hundreds of dollars each month without achieving the desired outcome.

By doing your own research with Google AdWords’ keyword planner, you will see the variations of keywords that you can use in the copy of your Web site and related content for organic SE

Patient conversion: Your ultimate goal

Google is only one piece of the Internet marketing puzzle. Once you have invested in mastering the SEO rankings (by doing it yourself or by paying for professional help), it’s up to your Web site to convert the visitor to a paying patient. To maximize your return on investment (ROI), implement marketing strategies and a patient conversion system on your Web site. When a prospective patient lands there, you have less than 10 seconds to engage her. In Part 1of this series, we discuss features that will keep your visitor involved while she navigates the site and make it easy for her to make an appointment. Don’t lose her because she can’t find your contact information hidden at the bottom of the page.²

If you don’t want to spend the time and effort to do it yourself, outsourcing is a cost-effective solution, and a trackable and measurable way for you to calculate your ROI.

Bottom line: Be seen on the Internet. We are all connected to the Internet every waking moment. This is where we go for information; this is how we communicate with each other; and this is where we create relationships. If you want to build your practice, you have to be where your patient can find you—on the top of an Internet search results page.

Share your thoughts on this article! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

It’s high time to go beyond relying on YellowPages.com to attract patients to your practice. According to research and analysis company BIA/Kelsey, “nearly all consumers (97%) now use online media to shop locally.”¹ Today’s patients are Internet savvy and expect their ObGyn not only to be a good physician who diagnoses and treats their conditions but also to demonstrate his or her electronic technical abilities, through online communication, a Web site, email newsletter outreach, and, yes, a social media presence.

Yet, being the best in your field or having an incredible Web site won’t matter if your existing patients and potential new patients can’t find you on the Internet. The solution? Get your Web site onto the first page of Google’s search results. Why? Google is still by far the dominant search engine in the United States, and it has the overwhelming ability to offer you an endless supply of patients. And can your practice survive without a steady flow of new patients?

Type a keyword into the Google search window and dozens, hundreds, or thousands of sites may become visible. Google lists 10 sites per page, however, and when was the last time you went to the second, third, or fourth results page looking for something? If your Web site does not appear on the first results page, you are essentially invisible. The good news is that you can easily and inexpensively reach the top of a search engine’s results page by knowing and applying best practices for effective search engine optimization (SEO; a free endeavor, although your time investment should considered) and/or utilizing a pay-per-click (PPC) service (for a fee that’s comparable to what you used to pay for your old Yellow Pages listing). In this article, we aim to provide to you the know-how to embark on these endeavors by defining SEO and PPC and relaying effective principles for marketing your practice to potential new patients.

What is SEO?

SEO refers to techniques that help your Web site rank higher in organic (natural) results, which helps your site, and you, become more visible to people who are seeking your services. Search engines specialize in offering Web surfers the best information about their search terms, or keywords. To do this, Google uses more than 200 different algorithms, some of which we know but most of which are not published.

The algorithms are used to determine where your Web site ranks according to a number of factors relevant to the content and set-up of each page of your Web site (on-page SEO) as well as everything you do outside of your Web site (off-page SEO) to enhance your SEO rankings. This relevance is calculated by looking at both on-page and off-page factors, including:

You have to work on both on-page and off-page factors many times a month to convince the search engines that you are a Web site worth visiting. Over time, your site will start to rise in the rankings and gain qualified traffic. Then you can concentrate on converting those Web site visitors to office-based patients.

A warning: If you use unethical tactics to get your Web site on the first page of the search results, Google will catch up to you—and your Web-site rankings will plummet.

Five important steps to increase SEO

There’s a system to reach the top of any search engine’s results page. The most important steps are to:

1 and 2. Keywords are key
Keywords are what an Internet surfer enters into a search function and what the search engine crawlers hunt for. The crawlers then direct the surfer to the Web site that is perceived as the best source of information.

Here are the most popular keywords used by potential patients looking for ­ObGyns: obstetrician, gynecologist, gynecology, vaginal discharge, vaginal dryness, breast self-exam, breast cancer screening, prolapsed bladder, pelvic pain, and adolescent gynecology. You also should include your city’s name as a keyword.

Use keywords in Web site coding and copy. Unless you are experienced in Web development, you’re better off hiring a professional who knows Internet coding to help you develop HTML meta tags, anchor text, a sitemap, etc. You easily can incorporate keywords in the copy on your Web site, but the keyword density should be no more than approximately 3% to 5% of the copy. (If it is more than 5%, it is considered “stuffing,” and not looked on kindly by Google.)

3. In-bound links: Who’s linking to you?
As the search engine crawlers scan Web pages for indexing, they also look for links from other Web sites. The greater number of quality in-bound links a Web site has, the stronger influence or authority it accrues.

In-bound links are weighted differently: a link from a highly authoritative Web site like NYTimes.com will give a Web site a bigger boost than a link from a small blog site. Links from high-ranking sites, such as city directories, hospitals, and online medical directories, improve your Web-site ranking. You should be submitting your Web site address and keyword description to these appropriate directories for in-bound links on a weekly or monthly basis.

4. Develop new content by blogging
Search engines place a high value on new content, and the easiest way to add new keyword-related content is to blog. Writing a 400-word keyword–relevant blog on a regular basis will provide the search engine crawlers with new content to graze.

As an added bonus, there are many medical ezines—small magazines and newsletters distributed by any electronic ­method—that regularly need content. Publication of your blog article will provide additional back-links to your Web site and improve your SEO rankings. This is your opportunity to go “viral,” have your material read by thousands, and increase visits to your Web site. When your name appears on multiple sites, you create the perception of demonstrating your expertise in various topics, techniques, and therapeutic options.

5. Search engines love social media
Newer technologies are given greater weight in determining Web page ranking. Start with blogging and then add Facebook, YouTube, and Twitter. Always remember to link from these sites with relevant keywords to the exact page on your site that contains the best information for those keywords.

Advertise your practice using PPC (Google AdWords)

Google, Yahoo, and other Internet portals make their money by selling advertisements on search-results pages. Both paid and organic listings appear on the search results pages, but they are displayed in different locations. On Google, PPC listings are found on the top and right side of each page under the header “Ads” (FIGURE 1). The organic or natural search (no payment required) is on the left below the ads.

On Google, the PPC function is called ­“AdWords” (http://www.google.com/adwords). On the AdWords page, a listing is found that offers how many times people type in certain words or phrases—keywords. Google AdWords allows the marketplace to bid on keywords; the higher the bid, the closer to the top position on the first page of the Google search results. Depending on monthly search volume, popularity, and competition, you can pay anywhere from pennies to $25 each time a Web surfer clicks on your ad. In FIGURE 2, you can see that a suggested bid for “Gynecologist Miami” is $2.96.

You must constantly monitor and manage your AdWords account. Test different landing pages, adjust your copy, and change offerings to make sure you are converting your paid traffic to patients. Otherwise, you can spend hundreds of dollars each month without achieving the desired outcome.

By doing your own research with Google AdWords’ keyword planner, you will see the variations of keywords that you can use in the copy of your Web site and related content for organic SE

Patient conversion: Your ultimate goal

Google is only one piece of the Internet marketing puzzle. Once you have invested in mastering the SEO rankings (by doing it yourself or by paying for professional help), it’s up to your Web site to convert the visitor to a paying patient. To maximize your return on investment (ROI), implement marketing strategies and a patient conversion system on your Web site. When a prospective patient lands there, you have less than 10 seconds to engage her. In Part 1of this series, we discuss features that will keep your visitor involved while she navigates the site and make it easy for her to make an appointment. Don’t lose her because she can’t find your contact information hidden at the bottom of the page.²

If you don’t want to spend the time and effort to do it yourself, outsourcing is a cost-effective solution, and a trackable and measurable way for you to calculate your ROI.

Bottom line: Be seen on the Internet. We are all connected to the Internet every waking moment. This is where we go for information; this is how we communicate with each other; and this is where we create relationships. If you want to build your practice, you have to be where your patient can find you—on the top of an Internet search results page.

Share your thoughts on this article! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.