Study: Uterus Preservation Feasible with Mesh POP Repair System

LAS VEGAS – The Elevate Anterior and Apical system – a transvaginal synthetic mesh repair system – was just as effective when pelvic organ prolapse repair was performed with or without uterine preservation in a prospective, multicenter trial.

Complication rates, including extrusion rates, were low, and there was long-term durability at 24 months, Dr. Edward J. Stanford said at the 41st AAGL Global Ccongress.

"In our opinion, the results support [the idea] that concomitant hysterectomy may not be, or is not, necessary in patients who, after informed consent, would like to preserve their uterus," he said.

The Elevate Anterior and Apical (EAA) transvaginal polypropylene mesh pelvic organ prolapse (POP) repair system is contraindicated in pregnant women and women planning future pregnancies, as the graft will not stretch significantly as the patient grows, according to the device manufacturer, American Medical Systems.

Concerns about the safety and efficacy of transvaginally placed synthetic mesh for POP prompted the American College of Obstetricians and Gynecologists (ACOG) and the American Urogynecologic Society (AUGS) in late 2011 to recommend that such repairs be reserved for "high-risk patients in whom the benefit of mesh placement may justify the risk, such as those with recurrent prolapse" (Obstet. Gynecol. 2011;118:1459-64).

Dr. Stanford and his fellow investigators at 10 U.S. and 6 European sites sought to prospectively explore the efficacy of the EAA system when utilized with or without uterine preservation in 142 women with anterior vaginal prolapse and/or apical descent of at least stage II.

The primary outcome was treatment failure, defined as at least stage II of the Pelvic Organ Prolapse Quantification system (leading edge of prolapse within 1 cm of the hymenal ring) during follow-up, using the last observation carried forward method.

Three subgroups were analyzed: 61 women with a baseline, prior hysterectomy; 29 with a concomitant hysterectomy; and 51 with no hysterectomy. The groups were well balanced, although 10% of the concomitant group was current smokers, compared with roughly 2% in the other groups. Median gravity was 3 and median parity 2. Their average age was 64 years.

For the apical compartment, success at 24 months was reported in 29 patients with a prior hysterectomy (93.5%), 17 with a concomitant hysterectomy (94.4%), and 24 with no hysterectomy (100%), reported Dr. Stanford, a health care consultant in Las Vegas. Notably, data were missing for 30 of the 61 prior hysterectomy patients, 11 of the 29 concomitant patients, and 27 of the 51 uterine preservation patients.

For the anterior compartment, success was slightly lower at 79.6% with a prior hysterectomy (43 patients), 70.8% with a concomitant hysterectomy (17 patients), and 89% with uterine preservation (41 patients). Data were missing for 7, 5, and 5 patients, respectively.

There was no significant difference in success between the groups for the apical (P = .46) or anterior (P = .154) compartments, he said.

Dr. Stanford defended the use of the study’s methodology in an interview, and said that the last observation carried forward method was the best way to account for missing data.

"It penalized those groups with missing data, and our results were still good," he said.

Three patients in the prior and current hysterectomy groups experienced an intraoperative complication, as did seven patients with uterine preservation. Estimated blood loss was similar at a median of 50 mL in each group.

There was a nonsignificant trend toward higher mesh extrusion in women undergoing a concomitant hysterectomy (13.8%; 4 of 29), compared with those with a prior hysterectomy (5%; 3 of 61) or no hysterectomy (2%; 1 of 51), Dr. Stanford said.

"We are a little concerned that the higher extrusion rate with a concomitant hysterectomy, which has been seen in other studies, is coming true in this study as well," he added. "Perhaps, the higher number of smokers in that subgroup may be a factor."

Smoking and urogenital atrophy have been acknowledged as risk factors for mesh erosion. About 42% of patients were on vaginal or topical estrogen prior to surgery, and all received preoperative antibiotics, he said during a discussion of the study.

Almost all of the failures occurred early on, up to 3 months after surgery, with extrusion rates remaining stable from year 1 to year 2, Dr. Stanford said in an interview.

"A lot of experts are saying that late complications are happening on a regular basis, but we’re just not seeing it in our data or in other prolapse studies," he said.

Dr. Stanford contends that reported extrusion rates of 15% or more occurred primarily among surgeons still learning the technique. He credits the high success rate in the current study to the use of a standardized approach and the expertise of the surgeons, who were given specific training on the Elevate system and perform at least 100 vaginal mesh repairs annually.

"It’s a long learning curve, and you have to continue with an adequate volume and know how to do a proper dissection," he said. "You need about 25 to 50 cases to have a level of expertise, which is consistent with the surgical literature. We know that’s true of total laparoscopic hysterectomy as well."

In its joint communication, ACOG and AUGS recommended that surgeons placing vaginal mesh undergo training specific to each device, have experience with reconstructive surgical procedures, and have a thorough understanding of pelvic anatomy.

Based on the current limited data, the two groups said there is a "small, but significant group" of patients who experience permanent or life-altering sequelae as result of the transvaginal mesh placement.

In its updated July 2011 safety report, however, the Food and Drug Administration said that serious complications related to POP transvaginal mesh repair "are not rare," and that the procedure "may expose patients to greater risk" than traditional nonmesh repair.

The FDA’s Obstetrics and Gynecology Devices Panel subsequently called for postmarket studies to evaluate current products, and recommended that new vaginal mesh products for POP repair not be approved through the less rigorous Class II 501(k) process, but reclassified as Class III to ensure that premarket clinical studies are conducted.

Law firms are aggressively litigating cases against transvaginal mesh manufacturers, with commercials soliciting new clients airing on local television in Las Vegas throughout the AAGL meeting. American Medical Systems, which also manufactures the Apogee and Perigee mesh products, is one of several companies to be named in at least six ongoing multidistrict litigations.

Dr. Stanford said the current data are reassuring, and that there were no significant differences between women with or without uterine preservation in quality of life scores on the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire-12 (PISQ-12), Pelvic Floor Incontinence Questionnaire-7 (PFIQ-7), and Pelvic Floor Distress Inventory (PFDI).

Dr. Stanford disclosed a research grant from study sponsor American Medical Systems, maker of the Elevate system.

LAS VEGAS – The Elevate Anterior and Apical system – a transvaginal synthetic mesh repair system – was just as effective when pelvic organ prolapse repair was performed with or without uterine preservation in a prospective, multicenter trial.

Complication rates, including extrusion rates, were low, and there was long-term durability at 24 months, Dr. Edward J. Stanford said at the 41st AAGL Global Ccongress.

"In our opinion, the results support [the idea] that concomitant hysterectomy may not be, or is not, necessary in patients who, after informed consent, would like to preserve their uterus," he said.

The Elevate Anterior and Apical (EAA) transvaginal polypropylene mesh pelvic organ prolapse (POP) repair system is contraindicated in pregnant women and women planning future pregnancies, as the graft will not stretch significantly as the patient grows, according to the device manufacturer, American Medical Systems.

Concerns about the safety and efficacy of transvaginally placed synthetic mesh for POP prompted the American College of Obstetricians and Gynecologists (ACOG) and the American Urogynecologic Society (AUGS) in late 2011 to recommend that such repairs be reserved for "high-risk patients in whom the benefit of mesh placement may justify the risk, such as those with recurrent prolapse" (Obstet. Gynecol. 2011;118:1459-64).

Dr. Stanford and his fellow investigators at 10 U.S. and 6 European sites sought to prospectively explore the efficacy of the EAA system when utilized with or without uterine preservation in 142 women with anterior vaginal prolapse and/or apical descent of at least stage II.

The primary outcome was treatment failure, defined as at least stage II of the Pelvic Organ Prolapse Quantification system (leading edge of prolapse within 1 cm of the hymenal ring) during follow-up, using the last observation carried forward method.

Three subgroups were analyzed: 61 women with a baseline, prior hysterectomy; 29 with a concomitant hysterectomy; and 51 with no hysterectomy. The groups were well balanced, although 10% of the concomitant group was current smokers, compared with roughly 2% in the other groups. Median gravity was 3 and median parity 2. Their average age was 64 years.

For the apical compartment, success at 24 months was reported in 29 patients with a prior hysterectomy (93.5%), 17 with a concomitant hysterectomy (94.4%), and 24 with no hysterectomy (100%), reported Dr. Stanford, a health care consultant in Las Vegas. Notably, data were missing for 30 of the 61 prior hysterectomy patients, 11 of the 29 concomitant patients, and 27 of the 51 uterine preservation patients.

For the anterior compartment, success was slightly lower at 79.6% with a prior hysterectomy (43 patients), 70.8% with a concomitant hysterectomy (17 patients), and 89% with uterine preservation (41 patients). Data were missing for 7, 5, and 5 patients, respectively.

There was no significant difference in success between the groups for the apical (P = .46) or anterior (P = .154) compartments, he said.

Dr. Stanford defended the use of the study’s methodology in an interview, and said that the last observation carried forward method was the best way to account for missing data.

"It penalized those groups with missing data, and our results were still good," he said.

Three patients in the prior and current hysterectomy groups experienced an intraoperative complication, as did seven patients with uterine preservation. Estimated blood loss was similar at a median of 50 mL in each group.

There was a nonsignificant trend toward higher mesh extrusion in women undergoing a concomitant hysterectomy (13.8%; 4 of 29), compared with those with a prior hysterectomy (5%; 3 of 61) or no hysterectomy (2%; 1 of 51), Dr. Stanford said.

"We are a little concerned that the higher extrusion rate with a concomitant hysterectomy, which has been seen in other studies, is coming true in this study as well," he added. "Perhaps, the higher number of smokers in that subgroup may be a factor."

Smoking and urogenital atrophy have been acknowledged as risk factors for mesh erosion. About 42% of patients were on vaginal or topical estrogen prior to surgery, and all received preoperative antibiotics, he said during a discussion of the study.

Almost all of the failures occurred early on, up to 3 months after surgery, with extrusion rates remaining stable from year 1 to year 2, Dr. Stanford said in an interview.

"A lot of experts are saying that late complications are happening on a regular basis, but we’re just not seeing it in our data or in other prolapse studies," he said.

Dr. Stanford contends that reported extrusion rates of 15% or more occurred primarily among surgeons still learning the technique. He credits the high success rate in the current study to the use of a standardized approach and the expertise of the surgeons, who were given specific training on the Elevate system and perform at least 100 vaginal mesh repairs annually.

"It’s a long learning curve, and you have to continue with an adequate volume and know how to do a proper dissection," he said. "You need about 25 to 50 cases to have a level of expertise, which is consistent with the surgical literature. We know that’s true of total laparoscopic hysterectomy as well."

In its joint communication, ACOG and AUGS recommended that surgeons placing vaginal mesh undergo training specific to each device, have experience with reconstructive surgical procedures, and have a thorough understanding of pelvic anatomy.

Based on the current limited data, the two groups said there is a "small, but significant group" of patients who experience permanent or life-altering sequelae as result of the transvaginal mesh placement.

In its updated July 2011 safety report, however, the Food and Drug Administration said that serious complications related to POP transvaginal mesh repair "are not rare," and that the procedure "may expose patients to greater risk" than traditional nonmesh repair.

The FDA’s Obstetrics and Gynecology Devices Panel subsequently called for postmarket studies to evaluate current products, and recommended that new vaginal mesh products for POP repair not be approved through the less rigorous Class II 501(k) process, but reclassified as Class III to ensure that premarket clinical studies are conducted.

Law firms are aggressively litigating cases against transvaginal mesh manufacturers, with commercials soliciting new clients airing on local television in Las Vegas throughout the AAGL meeting. American Medical Systems, which also manufactures the Apogee and Perigee mesh products, is one of several companies to be named in at least six ongoing multidistrict litigations.

Dr. Stanford said the current data are reassuring, and that there were no significant differences between women with or without uterine preservation in quality of life scores on the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire-12 (PISQ-12), Pelvic Floor Incontinence Questionnaire-7 (PFIQ-7), and Pelvic Floor Distress Inventory (PFDI).

Dr. Stanford disclosed a research grant from study sponsor American Medical Systems, maker of the Elevate system.

LAS VEGAS – The Elevate Anterior and Apical system – a transvaginal synthetic mesh repair system – was just as effective when pelvic organ prolapse repair was performed with or without uterine preservation in a prospective, multicenter trial.

Complication rates, including extrusion rates, were low, and there was long-term durability at 24 months, Dr. Edward J. Stanford said at the 41st AAGL Global Ccongress.

"In our opinion, the results support [the idea] that concomitant hysterectomy may not be, or is not, necessary in patients who, after informed consent, would like to preserve their uterus," he said.

The Elevate Anterior and Apical (EAA) transvaginal polypropylene mesh pelvic organ prolapse (POP) repair system is contraindicated in pregnant women and women planning future pregnancies, as the graft will not stretch significantly as the patient grows, according to the device manufacturer, American Medical Systems.

Concerns about the safety and efficacy of transvaginally placed synthetic mesh for POP prompted the American College of Obstetricians and Gynecologists (ACOG) and the American Urogynecologic Society (AUGS) in late 2011 to recommend that such repairs be reserved for "high-risk patients in whom the benefit of mesh placement may justify the risk, such as those with recurrent prolapse" (Obstet. Gynecol. 2011;118:1459-64).

Dr. Stanford and his fellow investigators at 10 U.S. and 6 European sites sought to prospectively explore the efficacy of the EAA system when utilized with or without uterine preservation in 142 women with anterior vaginal prolapse and/or apical descent of at least stage II.

The primary outcome was treatment failure, defined as at least stage II of the Pelvic Organ Prolapse Quantification system (leading edge of prolapse within 1 cm of the hymenal ring) during follow-up, using the last observation carried forward method.

Three subgroups were analyzed: 61 women with a baseline, prior hysterectomy; 29 with a concomitant hysterectomy; and 51 with no hysterectomy. The groups were well balanced, although 10% of the concomitant group was current smokers, compared with roughly 2% in the other groups. Median gravity was 3 and median parity 2. Their average age was 64 years.

For the apical compartment, success at 24 months was reported in 29 patients with a prior hysterectomy (93.5%), 17 with a concomitant hysterectomy (94.4%), and 24 with no hysterectomy (100%), reported Dr. Stanford, a health care consultant in Las Vegas. Notably, data were missing for 30 of the 61 prior hysterectomy patients, 11 of the 29 concomitant patients, and 27 of the 51 uterine preservation patients.

For the anterior compartment, success was slightly lower at 79.6% with a prior hysterectomy (43 patients), 70.8% with a concomitant hysterectomy (17 patients), and 89% with uterine preservation (41 patients). Data were missing for 7, 5, and 5 patients, respectively.

There was no significant difference in success between the groups for the apical (P = .46) or anterior (P = .154) compartments, he said.

Dr. Stanford defended the use of the study’s methodology in an interview, and said that the last observation carried forward method was the best way to account for missing data.

"It penalized those groups with missing data, and our results were still good," he said.

Three patients in the prior and current hysterectomy groups experienced an intraoperative complication, as did seven patients with uterine preservation. Estimated blood loss was similar at a median of 50 mL in each group.

There was a nonsignificant trend toward higher mesh extrusion in women undergoing a concomitant hysterectomy (13.8%; 4 of 29), compared with those with a prior hysterectomy (5%; 3 of 61) or no hysterectomy (2%; 1 of 51), Dr. Stanford said.

"We are a little concerned that the higher extrusion rate with a concomitant hysterectomy, which has been seen in other studies, is coming true in this study as well," he added. "Perhaps, the higher number of smokers in that subgroup may be a factor."

Smoking and urogenital atrophy have been acknowledged as risk factors for mesh erosion. About 42% of patients were on vaginal or topical estrogen prior to surgery, and all received preoperative antibiotics, he said during a discussion of the study.

Almost all of the failures occurred early on, up to 3 months after surgery, with extrusion rates remaining stable from year 1 to year 2, Dr. Stanford said in an interview.

"A lot of experts are saying that late complications are happening on a regular basis, but we’re just not seeing it in our data or in other prolapse studies," he said.

Dr. Stanford contends that reported extrusion rates of 15% or more occurred primarily among surgeons still learning the technique. He credits the high success rate in the current study to the use of a standardized approach and the expertise of the surgeons, who were given specific training on the Elevate system and perform at least 100 vaginal mesh repairs annually.

"It’s a long learning curve, and you have to continue with an adequate volume and know how to do a proper dissection," he said. "You need about 25 to 50 cases to have a level of expertise, which is consistent with the surgical literature. We know that’s true of total laparoscopic hysterectomy as well."

In its joint communication, ACOG and AUGS recommended that surgeons placing vaginal mesh undergo training specific to each device, have experience with reconstructive surgical procedures, and have a thorough understanding of pelvic anatomy.

Based on the current limited data, the two groups said there is a "small, but significant group" of patients who experience permanent or life-altering sequelae as result of the transvaginal mesh placement.

In its updated July 2011 safety report, however, the Food and Drug Administration said that serious complications related to POP transvaginal mesh repair "are not rare," and that the procedure "may expose patients to greater risk" than traditional nonmesh repair.

The FDA’s Obstetrics and Gynecology Devices Panel subsequently called for postmarket studies to evaluate current products, and recommended that new vaginal mesh products for POP repair not be approved through the less rigorous Class II 501(k) process, but reclassified as Class III to ensure that premarket clinical studies are conducted.

Law firms are aggressively litigating cases against transvaginal mesh manufacturers, with commercials soliciting new clients airing on local television in Las Vegas throughout the AAGL meeting. American Medical Systems, which also manufactures the Apogee and Perigee mesh products, is one of several companies to be named in at least six ongoing multidistrict litigations.

Dr. Stanford said the current data are reassuring, and that there were no significant differences between women with or without uterine preservation in quality of life scores on the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire-12 (PISQ-12), Pelvic Floor Incontinence Questionnaire-7 (PFIQ-7), and Pelvic Floor Distress Inventory (PFDI).

Dr. Stanford disclosed a research grant from study sponsor American Medical Systems, maker of the Elevate system.