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FDA bans 24 ingredients from OTC health care antiseptic products
in hospital settings and other health care situations outside the hospital, the U.S. Food and Drug Administration announced in a final rule.
The affected products include health care personnel hand washes and hand rubs, surgical hand scrubs and hand rubs, and patient antiseptic skin preparations. The final rule was published Dec. 20 in the Federal Register and becomes effective in December 2018.
The agency determined that a deferral is warranted for six health care antiseptic active ingredients – benzalkonium chloride, benzethonium chloride, chloroxylenol, alcohol, isopropyl alcohol, and povidone-iodine – to allow more time for interested parties to complete the studies necessary to fill the safety and effectiveness data gaps identified for these ingredients.
“The FDA expects that this information may help better inform us on antiseptic resistance and antibiotic cross-resistance in the health care setting,” FDA Commissioner Scott Gottlieb, MD, said in a statement. “Importantly, this doesn’t mean that products containing these six ingredients are ineffective or unsafe. These antiseptic products remain an important resource in health care settings. Personnel should continue to use these products consistent with infection control guidelines while the additional data are gathered.”
No additional data was provided for another 24 products, which were deemed not generally recognized as safe and effective. The minimum data needed to demonstrate safety for all health care antiseptic active ingredients fall into four broad categories: human safety studies, nonclinical safety studies (developmental and reproductive toxicity studies and carcinogenicity studies), data to characterize potential hormonal effects, and data to evaluate the development of antimicrobial resistance, the final rule states.
The FDA noted that manufacturers started to remove nearly all of these 24 active ingredients from their products following a 2015 proposed rule. Triclosan is currently being used in available products.
The active ingredients affected are chlorhexidine gluconate; cloflucarban; fluorosalan; hexachlorophene; hexylresorcinol; iodophors (iodine-containing ingredients including iodine complex [ammonium ether sulfate and polyoxyethylene sorbitan monolaurate], iodine complex [phosphate ester of alkylaryloxy polyethylene glycol], iodine tincture USP, iodine topical solution USP, nonylphenoxypoly [ethyleneoxy] ethanoliodine, poloxamer–iodine complex, undecoylium chloride iodine complex); mercufenol chloride; methylbenzethonium chloride; phenol; secondary amyltricresols; sodium oxychlorosene; tribromsalan; triclocarban; triclosan; triple dye; combination of calomel, oxyquinoline benzoate, triethanolamine, and phenol derivative; and combination of mercufenol chloride and secondary amyltricresols in 50% alcohol.
If manufacturers want to use one or more of these 24 active ingredients in future OTC health care antiseptic drug products, those products will be considered new drugs for which a new drug application approval will be required, the agency said.
The rule does not affect health care antiseptics that are currently marketed under new drug applications and abbreviated new drug applications.
FDA’s action follows a similar final rule published Sept. 6, 2016, which removed triclosan and 18 other active ingredients from consumer antiseptic products.
in hospital settings and other health care situations outside the hospital, the U.S. Food and Drug Administration announced in a final rule.
The affected products include health care personnel hand washes and hand rubs, surgical hand scrubs and hand rubs, and patient antiseptic skin preparations. The final rule was published Dec. 20 in the Federal Register and becomes effective in December 2018.
The agency determined that a deferral is warranted for six health care antiseptic active ingredients – benzalkonium chloride, benzethonium chloride, chloroxylenol, alcohol, isopropyl alcohol, and povidone-iodine – to allow more time for interested parties to complete the studies necessary to fill the safety and effectiveness data gaps identified for these ingredients.
“The FDA expects that this information may help better inform us on antiseptic resistance and antibiotic cross-resistance in the health care setting,” FDA Commissioner Scott Gottlieb, MD, said in a statement. “Importantly, this doesn’t mean that products containing these six ingredients are ineffective or unsafe. These antiseptic products remain an important resource in health care settings. Personnel should continue to use these products consistent with infection control guidelines while the additional data are gathered.”
No additional data was provided for another 24 products, which were deemed not generally recognized as safe and effective. The minimum data needed to demonstrate safety for all health care antiseptic active ingredients fall into four broad categories: human safety studies, nonclinical safety studies (developmental and reproductive toxicity studies and carcinogenicity studies), data to characterize potential hormonal effects, and data to evaluate the development of antimicrobial resistance, the final rule states.
The FDA noted that manufacturers started to remove nearly all of these 24 active ingredients from their products following a 2015 proposed rule. Triclosan is currently being used in available products.
The active ingredients affected are chlorhexidine gluconate; cloflucarban; fluorosalan; hexachlorophene; hexylresorcinol; iodophors (iodine-containing ingredients including iodine complex [ammonium ether sulfate and polyoxyethylene sorbitan monolaurate], iodine complex [phosphate ester of alkylaryloxy polyethylene glycol], iodine tincture USP, iodine topical solution USP, nonylphenoxypoly [ethyleneoxy] ethanoliodine, poloxamer–iodine complex, undecoylium chloride iodine complex); mercufenol chloride; methylbenzethonium chloride; phenol; secondary amyltricresols; sodium oxychlorosene; tribromsalan; triclocarban; triclosan; triple dye; combination of calomel, oxyquinoline benzoate, triethanolamine, and phenol derivative; and combination of mercufenol chloride and secondary amyltricresols in 50% alcohol.
If manufacturers want to use one or more of these 24 active ingredients in future OTC health care antiseptic drug products, those products will be considered new drugs for which a new drug application approval will be required, the agency said.
The rule does not affect health care antiseptics that are currently marketed under new drug applications and abbreviated new drug applications.
FDA’s action follows a similar final rule published Sept. 6, 2016, which removed triclosan and 18 other active ingredients from consumer antiseptic products.
in hospital settings and other health care situations outside the hospital, the U.S. Food and Drug Administration announced in a final rule.
The affected products include health care personnel hand washes and hand rubs, surgical hand scrubs and hand rubs, and patient antiseptic skin preparations. The final rule was published Dec. 20 in the Federal Register and becomes effective in December 2018.
The agency determined that a deferral is warranted for six health care antiseptic active ingredients – benzalkonium chloride, benzethonium chloride, chloroxylenol, alcohol, isopropyl alcohol, and povidone-iodine – to allow more time for interested parties to complete the studies necessary to fill the safety and effectiveness data gaps identified for these ingredients.
“The FDA expects that this information may help better inform us on antiseptic resistance and antibiotic cross-resistance in the health care setting,” FDA Commissioner Scott Gottlieb, MD, said in a statement. “Importantly, this doesn’t mean that products containing these six ingredients are ineffective or unsafe. These antiseptic products remain an important resource in health care settings. Personnel should continue to use these products consistent with infection control guidelines while the additional data are gathered.”
No additional data was provided for another 24 products, which were deemed not generally recognized as safe and effective. The minimum data needed to demonstrate safety for all health care antiseptic active ingredients fall into four broad categories: human safety studies, nonclinical safety studies (developmental and reproductive toxicity studies and carcinogenicity studies), data to characterize potential hormonal effects, and data to evaluate the development of antimicrobial resistance, the final rule states.
The FDA noted that manufacturers started to remove nearly all of these 24 active ingredients from their products following a 2015 proposed rule. Triclosan is currently being used in available products.
The active ingredients affected are chlorhexidine gluconate; cloflucarban; fluorosalan; hexachlorophene; hexylresorcinol; iodophors (iodine-containing ingredients including iodine complex [ammonium ether sulfate and polyoxyethylene sorbitan monolaurate], iodine complex [phosphate ester of alkylaryloxy polyethylene glycol], iodine tincture USP, iodine topical solution USP, nonylphenoxypoly [ethyleneoxy] ethanoliodine, poloxamer–iodine complex, undecoylium chloride iodine complex); mercufenol chloride; methylbenzethonium chloride; phenol; secondary amyltricresols; sodium oxychlorosene; tribromsalan; triclocarban; triclosan; triple dye; combination of calomel, oxyquinoline benzoate, triethanolamine, and phenol derivative; and combination of mercufenol chloride and secondary amyltricresols in 50% alcohol.
If manufacturers want to use one or more of these 24 active ingredients in future OTC health care antiseptic drug products, those products will be considered new drugs for which a new drug application approval will be required, the agency said.
The rule does not affect health care antiseptics that are currently marketed under new drug applications and abbreviated new drug applications.
FDA’s action follows a similar final rule published Sept. 6, 2016, which removed triclosan and 18 other active ingredients from consumer antiseptic products.
FDA: Laparoscopic power morcellators can spread malignant cells when used in women with occult uterine cancers*
Laparoscopic power morcellation appears capable of spreading fulminant uterine malignancies when used to remove uterine fibroids from women who have unsuspected uterine cancers.
A new Food and Drug Administration literature review of 23 studies found consistent evidence that women who undergo surgery using laparoscopic power morcellators (LPMs) for fibroids that were assumed to be benign may have an occult uterine sarcoma or leiomyosarcoma. In the FDA’s literature review of 12 studies from 2014 to 2016, women who received power morcellation were at a significantly increased risk of death, compared with those whose fibroids were removed by other methods.
The findings reaffirm the agency’s 2014 warnings about LPMs:
• LPMs are contraindicated in gynecologic surgery in which the tissue to be morcellated is known or suspected to contain malignancy.
• LPMs are contraindicated for removal of uterine tissue containing suspected fibroids in patients who are peri- or postmenopausal, or in candidates for en bloc tissue removal.
• Boxed warning: Uterine tissue may contain unsuspected cancer. The use of LPMs during fibroid surgery may spread cancer and decrease long-term survival of patients. This information should be shared with patients when considering surgery with the use of these devices.
“We recognize that some health organizations have reported a lower estimate of risk and that some groups continue to request that we scale back our recommendations. However, after looking at all the relevant data, we believe our estimates remain accurate, and our recommendation against the use of this device to remove fibroids in the vast majority of women is appropriate and critical to better protecting these women. We are committed to continuing to review new relevant data to assure patient safety.”
The review determined that 1 in 350 women undergoing hysterectomy or myomectomy for fibroids may have an occult uterine sarcoma, and that 1 in about 500 have an unsuspected leiomyosarcoma. The literature review clearly identified increased risk of uterine cancers and decreased survival when these women are treated with an LPM, as opposed to manual morcellation or en bloc removal.
Twelve studies of women with uterine cancers examined this outcome in comparison groups. LPMs were associated with a 2- to 3-times increased risk of disease recurrence, compared with manual morcellation or other fibroid removal methods. In some studies, disease-free survival was significantly shorter among those who had undergone an LPM procedure; others found a higher risk of death – including, in one study, almost a quintupling of mortality risk by 1 year (crude risk ratio, 4.75).
Device-related malignancies began appearing in 2013; since then, 262 cases have been reported. But after the 2014 warning, use of LPMs in this application has decreased sharply. Two studies examined this, one finding that LPM use in fibroid surgery dropped from 14% to 3% and the other, that it dropped from 11% to 0.02%.
“The agency also continues to recommend that the advantages and risks of using LPMs during fibroid surgery be thoroughly discussed between the patient and physician before surgery,” the paper concluded. “FDA continues to actively encourage and engage in research to evaluate outcomes for a range of treatment options for fibroids and support the development of safer alternatives for providing a minimally invasive approach.”
[email protected]
Laparoscopic power morcellation appears capable of spreading fulminant uterine malignancies when used to remove uterine fibroids from women who have unsuspected uterine cancers.
A new Food and Drug Administration literature review of 23 studies found consistent evidence that women who undergo surgery using laparoscopic power morcellators (LPMs) for fibroids that were assumed to be benign may have an occult uterine sarcoma or leiomyosarcoma. In the FDA’s literature review of 12 studies from 2014 to 2016, women who received power morcellation were at a significantly increased risk of death, compared with those whose fibroids were removed by other methods.
The findings reaffirm the agency’s 2014 warnings about LPMs:
• LPMs are contraindicated in gynecologic surgery in which the tissue to be morcellated is known or suspected to contain malignancy.
• LPMs are contraindicated for removal of uterine tissue containing suspected fibroids in patients who are peri- or postmenopausal, or in candidates for en bloc tissue removal.
• Boxed warning: Uterine tissue may contain unsuspected cancer. The use of LPMs during fibroid surgery may spread cancer and decrease long-term survival of patients. This information should be shared with patients when considering surgery with the use of these devices.
“We recognize that some health organizations have reported a lower estimate of risk and that some groups continue to request that we scale back our recommendations. However, after looking at all the relevant data, we believe our estimates remain accurate, and our recommendation against the use of this device to remove fibroids in the vast majority of women is appropriate and critical to better protecting these women. We are committed to continuing to review new relevant data to assure patient safety.”
The review determined that 1 in 350 women undergoing hysterectomy or myomectomy for fibroids may have an occult uterine sarcoma, and that 1 in about 500 have an unsuspected leiomyosarcoma. The literature review clearly identified increased risk of uterine cancers and decreased survival when these women are treated with an LPM, as opposed to manual morcellation or en bloc removal.
Twelve studies of women with uterine cancers examined this outcome in comparison groups. LPMs were associated with a 2- to 3-times increased risk of disease recurrence, compared with manual morcellation or other fibroid removal methods. In some studies, disease-free survival was significantly shorter among those who had undergone an LPM procedure; others found a higher risk of death – including, in one study, almost a quintupling of mortality risk by 1 year (crude risk ratio, 4.75).
Device-related malignancies began appearing in 2013; since then, 262 cases have been reported. But after the 2014 warning, use of LPMs in this application has decreased sharply. Two studies examined this, one finding that LPM use in fibroid surgery dropped from 14% to 3% and the other, that it dropped from 11% to 0.02%.
“The agency also continues to recommend that the advantages and risks of using LPMs during fibroid surgery be thoroughly discussed between the patient and physician before surgery,” the paper concluded. “FDA continues to actively encourage and engage in research to evaluate outcomes for a range of treatment options for fibroids and support the development of safer alternatives for providing a minimally invasive approach.”
[email protected]
Laparoscopic power morcellation appears capable of spreading fulminant uterine malignancies when used to remove uterine fibroids from women who have unsuspected uterine cancers.
A new Food and Drug Administration literature review of 23 studies found consistent evidence that women who undergo surgery using laparoscopic power morcellators (LPMs) for fibroids that were assumed to be benign may have an occult uterine sarcoma or leiomyosarcoma. In the FDA’s literature review of 12 studies from 2014 to 2016, women who received power morcellation were at a significantly increased risk of death, compared with those whose fibroids were removed by other methods.
The findings reaffirm the agency’s 2014 warnings about LPMs:
• LPMs are contraindicated in gynecologic surgery in which the tissue to be morcellated is known or suspected to contain malignancy.
• LPMs are contraindicated for removal of uterine tissue containing suspected fibroids in patients who are peri- or postmenopausal, or in candidates for en bloc tissue removal.
• Boxed warning: Uterine tissue may contain unsuspected cancer. The use of LPMs during fibroid surgery may spread cancer and decrease long-term survival of patients. This information should be shared with patients when considering surgery with the use of these devices.
“We recognize that some health organizations have reported a lower estimate of risk and that some groups continue to request that we scale back our recommendations. However, after looking at all the relevant data, we believe our estimates remain accurate, and our recommendation against the use of this device to remove fibroids in the vast majority of women is appropriate and critical to better protecting these women. We are committed to continuing to review new relevant data to assure patient safety.”
The review determined that 1 in 350 women undergoing hysterectomy or myomectomy for fibroids may have an occult uterine sarcoma, and that 1 in about 500 have an unsuspected leiomyosarcoma. The literature review clearly identified increased risk of uterine cancers and decreased survival when these women are treated with an LPM, as opposed to manual morcellation or en bloc removal.
Twelve studies of women with uterine cancers examined this outcome in comparison groups. LPMs were associated with a 2- to 3-times increased risk of disease recurrence, compared with manual morcellation or other fibroid removal methods. In some studies, disease-free survival was significantly shorter among those who had undergone an LPM procedure; others found a higher risk of death – including, in one study, almost a quintupling of mortality risk by 1 year (crude risk ratio, 4.75).
Device-related malignancies began appearing in 2013; since then, 262 cases have been reported. But after the 2014 warning, use of LPMs in this application has decreased sharply. Two studies examined this, one finding that LPM use in fibroid surgery dropped from 14% to 3% and the other, that it dropped from 11% to 0.02%.
“The agency also continues to recommend that the advantages and risks of using LPMs during fibroid surgery be thoroughly discussed between the patient and physician before surgery,” the paper concluded. “FDA continues to actively encourage and engage in research to evaluate outcomes for a range of treatment options for fibroids and support the development of safer alternatives for providing a minimally invasive approach.”
[email protected]
Survey: Safety, rather than ethics, tops concerns about uterine transplantation
Uterine transplantation is generally seen as ethical, with acceptable risk levels for both donors and recipients, according to two parallel surveys given to women’s health physicians and to the general public.
The results, presented at the annual meeting of the American Society for Reproductive Medicine (ASRM), showed that “the majority of gynecologists surveyed find uterine transplantation to be an acceptable and ethical option for patients with uterine factor infertility,” wrote Pietro Bortoletto, MD, and his coauthors.
Similarly, about two-thirds of the general public found uterine transplantation permissible and ethical, according to responses from an age- and gender-balanced nationally representative survey.
The web-based surveys were designed to assess the personal beliefs of both the public and of physicians about the permissibility of uterine transplantation, and to evaluate respondents’ concerns about perceived risks associated with the procedure. Respondents in each survey were also asked to identify any ethical concerns they might have; recipients of both surveys received background information about uterine transplantation.
Dr. Bortoletto and his colleagues sent the survey by email to physicians who were members of ASRM and AAGL. Of the 4,216 physicians who were invited to take the survey, 447 (28.4%) completed it, though results were tallied just for the 414 respondents who were United States–based physicians.
Physician respondents, when asked whether women should be allowed to donate or receive a transplanted uterus, responded mostly in the affirmative: 20% strongly agreed and 36% agreed, while 23% were neutral. The remainder disagreed or strongly disagreed.
The possibility of complications for the recipient was identified as the top concern by about 50% of physician respondents. Next most concerning was fetal outcomes, of primary concern for about 28%, followed by complications to the donor and cost, each of which was of primary concern to 10% or fewer of the physician respondents.
The risk to donors of uterine transplantation was seen as acceptable by 73.7% of AAGL members and 71.7% of ASRM members; just over half of each group saw the risk as acceptable for the recipients and the infants, however.
Though over half of physician respondents (57.9% of AAGL members and 59.5% of ASRM members) felt that uterine transplantation should be a potential treatment option for women with absolute uterine factor infertility, fewer felt it should be covered by health insurance – 35.4% of AAGL members and 40.5% of ASRM members held this opinion.
Among the general public, over three quarters (78%) felt that women should be allowed to undergo uterine transplantation. Slightly fewer (67%) respondents to the public survey felt that uterine transplantation is ethical; those who agreed had slightly higher incomes and education levels (relative risk, 1.11 and 1.09, respectively). A similar number (66%) felt that uterine transplantation was an acceptable alternative to using a gestational carrier.
As was the case for physicians, fewer members of the general public (45%) agreed that health insurance should cover the procedure; here, women and Hispanics were more likely to agree (relative risk, 1.11 and 1.18, respectively).
The results of the survey of the general public were presented by first author Eduardo Hariton, MD, a coauthor of Dr. Bortoletto’s in the study of physician survey results. Both Dr. Hariton and Dr. Bortoletto are resident physicians in the department of obstetrics, gynecology, and reproductive biology at Brigham and Women’s Hospital, Boston.
The public survey was sent to a nationally representative sample, balanced by gender and age. Of 1,444 individuals who were recruited to receive the survey, 1,337 completed it. Ninety respondents reported that they found in vitro fertilization unacceptable; these responses were excluded, Dr. Hariton said in an interview. “We wanted to get at uterine transplantation per se,” rather than assisted reproductive technology in general.
Placing the ethics of uterine transplantation in a broader context, Dr. Bortoletto said in an interview that the United States is one of just a few countries that permit gestational surrogacy, with regulations varying by state. To his knowledge, he said, Ukraine and Russia are the only other two nations that permit compensation for surrogacy. Greece and the United Kingdom permit altruistic surrogacy, while gestational surrogacy of any sort is forbidden in the European Union. Thus, in those nations, uterine transplantation will be the only option for women who wish to bear their biological children.
“I think the main takeaway is that for people who had hesitation about [uterine transplantation], it was mainly around safety,” and not ethical concerns, said Dr. Hariton. “I was a bit surprised, but also encouraged, by the degree of support.”
Neither Dr. Hariton nor Dr. Bortoletto reported any conflicts of interest. The public opinion study was funded by an Expanding the Boundaries grant.
Uterine transplantation is generally seen as ethical, with acceptable risk levels for both donors and recipients, according to two parallel surveys given to women’s health physicians and to the general public.
The results, presented at the annual meeting of the American Society for Reproductive Medicine (ASRM), showed that “the majority of gynecologists surveyed find uterine transplantation to be an acceptable and ethical option for patients with uterine factor infertility,” wrote Pietro Bortoletto, MD, and his coauthors.
Similarly, about two-thirds of the general public found uterine transplantation permissible and ethical, according to responses from an age- and gender-balanced nationally representative survey.
The web-based surveys were designed to assess the personal beliefs of both the public and of physicians about the permissibility of uterine transplantation, and to evaluate respondents’ concerns about perceived risks associated with the procedure. Respondents in each survey were also asked to identify any ethical concerns they might have; recipients of both surveys received background information about uterine transplantation.
Dr. Bortoletto and his colleagues sent the survey by email to physicians who were members of ASRM and AAGL. Of the 4,216 physicians who were invited to take the survey, 447 (28.4%) completed it, though results were tallied just for the 414 respondents who were United States–based physicians.
Physician respondents, when asked whether women should be allowed to donate or receive a transplanted uterus, responded mostly in the affirmative: 20% strongly agreed and 36% agreed, while 23% were neutral. The remainder disagreed or strongly disagreed.
The possibility of complications for the recipient was identified as the top concern by about 50% of physician respondents. Next most concerning was fetal outcomes, of primary concern for about 28%, followed by complications to the donor and cost, each of which was of primary concern to 10% or fewer of the physician respondents.
The risk to donors of uterine transplantation was seen as acceptable by 73.7% of AAGL members and 71.7% of ASRM members; just over half of each group saw the risk as acceptable for the recipients and the infants, however.
Though over half of physician respondents (57.9% of AAGL members and 59.5% of ASRM members) felt that uterine transplantation should be a potential treatment option for women with absolute uterine factor infertility, fewer felt it should be covered by health insurance – 35.4% of AAGL members and 40.5% of ASRM members held this opinion.
Among the general public, over three quarters (78%) felt that women should be allowed to undergo uterine transplantation. Slightly fewer (67%) respondents to the public survey felt that uterine transplantation is ethical; those who agreed had slightly higher incomes and education levels (relative risk, 1.11 and 1.09, respectively). A similar number (66%) felt that uterine transplantation was an acceptable alternative to using a gestational carrier.
As was the case for physicians, fewer members of the general public (45%) agreed that health insurance should cover the procedure; here, women and Hispanics were more likely to agree (relative risk, 1.11 and 1.18, respectively).
The results of the survey of the general public were presented by first author Eduardo Hariton, MD, a coauthor of Dr. Bortoletto’s in the study of physician survey results. Both Dr. Hariton and Dr. Bortoletto are resident physicians in the department of obstetrics, gynecology, and reproductive biology at Brigham and Women’s Hospital, Boston.
The public survey was sent to a nationally representative sample, balanced by gender and age. Of 1,444 individuals who were recruited to receive the survey, 1,337 completed it. Ninety respondents reported that they found in vitro fertilization unacceptable; these responses were excluded, Dr. Hariton said in an interview. “We wanted to get at uterine transplantation per se,” rather than assisted reproductive technology in general.
Placing the ethics of uterine transplantation in a broader context, Dr. Bortoletto said in an interview that the United States is one of just a few countries that permit gestational surrogacy, with regulations varying by state. To his knowledge, he said, Ukraine and Russia are the only other two nations that permit compensation for surrogacy. Greece and the United Kingdom permit altruistic surrogacy, while gestational surrogacy of any sort is forbidden in the European Union. Thus, in those nations, uterine transplantation will be the only option for women who wish to bear their biological children.
“I think the main takeaway is that for people who had hesitation about [uterine transplantation], it was mainly around safety,” and not ethical concerns, said Dr. Hariton. “I was a bit surprised, but also encouraged, by the degree of support.”
Neither Dr. Hariton nor Dr. Bortoletto reported any conflicts of interest. The public opinion study was funded by an Expanding the Boundaries grant.
Uterine transplantation is generally seen as ethical, with acceptable risk levels for both donors and recipients, according to two parallel surveys given to women’s health physicians and to the general public.
The results, presented at the annual meeting of the American Society for Reproductive Medicine (ASRM), showed that “the majority of gynecologists surveyed find uterine transplantation to be an acceptable and ethical option for patients with uterine factor infertility,” wrote Pietro Bortoletto, MD, and his coauthors.
Similarly, about two-thirds of the general public found uterine transplantation permissible and ethical, according to responses from an age- and gender-balanced nationally representative survey.
The web-based surveys were designed to assess the personal beliefs of both the public and of physicians about the permissibility of uterine transplantation, and to evaluate respondents’ concerns about perceived risks associated with the procedure. Respondents in each survey were also asked to identify any ethical concerns they might have; recipients of both surveys received background information about uterine transplantation.
Dr. Bortoletto and his colleagues sent the survey by email to physicians who were members of ASRM and AAGL. Of the 4,216 physicians who were invited to take the survey, 447 (28.4%) completed it, though results were tallied just for the 414 respondents who were United States–based physicians.
Physician respondents, when asked whether women should be allowed to donate or receive a transplanted uterus, responded mostly in the affirmative: 20% strongly agreed and 36% agreed, while 23% were neutral. The remainder disagreed or strongly disagreed.
The possibility of complications for the recipient was identified as the top concern by about 50% of physician respondents. Next most concerning was fetal outcomes, of primary concern for about 28%, followed by complications to the donor and cost, each of which was of primary concern to 10% or fewer of the physician respondents.
The risk to donors of uterine transplantation was seen as acceptable by 73.7% of AAGL members and 71.7% of ASRM members; just over half of each group saw the risk as acceptable for the recipients and the infants, however.
Though over half of physician respondents (57.9% of AAGL members and 59.5% of ASRM members) felt that uterine transplantation should be a potential treatment option for women with absolute uterine factor infertility, fewer felt it should be covered by health insurance – 35.4% of AAGL members and 40.5% of ASRM members held this opinion.
Among the general public, over three quarters (78%) felt that women should be allowed to undergo uterine transplantation. Slightly fewer (67%) respondents to the public survey felt that uterine transplantation is ethical; those who agreed had slightly higher incomes and education levels (relative risk, 1.11 and 1.09, respectively). A similar number (66%) felt that uterine transplantation was an acceptable alternative to using a gestational carrier.
As was the case for physicians, fewer members of the general public (45%) agreed that health insurance should cover the procedure; here, women and Hispanics were more likely to agree (relative risk, 1.11 and 1.18, respectively).
The results of the survey of the general public were presented by first author Eduardo Hariton, MD, a coauthor of Dr. Bortoletto’s in the study of physician survey results. Both Dr. Hariton and Dr. Bortoletto are resident physicians in the department of obstetrics, gynecology, and reproductive biology at Brigham and Women’s Hospital, Boston.
The public survey was sent to a nationally representative sample, balanced by gender and age. Of 1,444 individuals who were recruited to receive the survey, 1,337 completed it. Ninety respondents reported that they found in vitro fertilization unacceptable; these responses were excluded, Dr. Hariton said in an interview. “We wanted to get at uterine transplantation per se,” rather than assisted reproductive technology in general.
Placing the ethics of uterine transplantation in a broader context, Dr. Bortoletto said in an interview that the United States is one of just a few countries that permit gestational surrogacy, with regulations varying by state. To his knowledge, he said, Ukraine and Russia are the only other two nations that permit compensation for surrogacy. Greece and the United Kingdom permit altruistic surrogacy, while gestational surrogacy of any sort is forbidden in the European Union. Thus, in those nations, uterine transplantation will be the only option for women who wish to bear their biological children.
“I think the main takeaway is that for people who had hesitation about [uterine transplantation], it was mainly around safety,” and not ethical concerns, said Dr. Hariton. “I was a bit surprised, but also encouraged, by the degree of support.”
Neither Dr. Hariton nor Dr. Bortoletto reported any conflicts of interest. The public opinion study was funded by an Expanding the Boundaries grant.
Clinical trial: Study underway of robot-assisted surgery for pelvic prolapse
Robotic Assisted Sacral Colpopexy: A Prospective Study Assessing Outcomes With Learning Curves is an open-label study that is being conducted on a new pelvic floor program for women with pelvic organ prolapse.
A prospective cohort of 100 patients will be recruited and the study will assess surgical time (total and specific essential portions), simulator training, and observed surgeon skills. Secondary endpoints include subjective outcomes for issues of sexual function and incontinence and adverse events such as genitourinary injury, blood loss, wound infection, and mesh erosion.
Kaiser Permanente is the trial sponsor, and patients aged 18-80 years who are undergoing robotic-assisted laparoscopic sacrocolpopexy with or without other procedures for pelvic organ prolapse are being recruited. For more details about the trial, visit https://goo.gl/pWq7qe.
SOURCE: ClinicalTrials.gov: NCT01535833.
Robotic Assisted Sacral Colpopexy: A Prospective Study Assessing Outcomes With Learning Curves is an open-label study that is being conducted on a new pelvic floor program for women with pelvic organ prolapse.
A prospective cohort of 100 patients will be recruited and the study will assess surgical time (total and specific essential portions), simulator training, and observed surgeon skills. Secondary endpoints include subjective outcomes for issues of sexual function and incontinence and adverse events such as genitourinary injury, blood loss, wound infection, and mesh erosion.
Kaiser Permanente is the trial sponsor, and patients aged 18-80 years who are undergoing robotic-assisted laparoscopic sacrocolpopexy with or without other procedures for pelvic organ prolapse are being recruited. For more details about the trial, visit https://goo.gl/pWq7qe.
SOURCE: ClinicalTrials.gov: NCT01535833.
Robotic Assisted Sacral Colpopexy: A Prospective Study Assessing Outcomes With Learning Curves is an open-label study that is being conducted on a new pelvic floor program for women with pelvic organ prolapse.
A prospective cohort of 100 patients will be recruited and the study will assess surgical time (total and specific essential portions), simulator training, and observed surgeon skills. Secondary endpoints include subjective outcomes for issues of sexual function and incontinence and adverse events such as genitourinary injury, blood loss, wound infection, and mesh erosion.
Kaiser Permanente is the trial sponsor, and patients aged 18-80 years who are undergoing robotic-assisted laparoscopic sacrocolpopexy with or without other procedures for pelvic organ prolapse are being recruited. For more details about the trial, visit https://goo.gl/pWq7qe.
SOURCE: ClinicalTrials.gov: NCT01535833.
SUMMARY FROM CLINICALTRIALS.GOV
Robotic hysterectomy plus mini-lap outperformed open procedure
NATIONAL HARBOR, MD. – Robotic hysterectomy combined with extraction of the uterus via mini-laparotomy led to significantly shorter lengths of stay, lower estimated blood loss, and fewer postoperative complications compared with open hysterectomy when the uterus weighed more than 250 grams.
Gynecologic surgeons are seeking ways to safely perform minimally invasive hysterectomy on patients with larger uteri in light of the 2014 Food and Drug Administration admonition regarding power morcellation. To this end, Natasha Gupta, MD, and her colleagues at the University of Tennessee, Chattanooga, retrospectively reviewed all patients with uterine sizes larger than 250 grams undergoing hysterectomy at their institution between 2012 and 2015.
“For the mini-laparotomy, the technique utilizes a customized incision connecting the two left port sites, followed by the removal of the specimen via this incision,” Dr. Gupta said at the AAGL Global Congress.
Patient factors and outcomes were compared via Student t-tests and Chi-square analysis.
Mean length of stay was significantly shorter for patients who underwent robotic hysterectomy/mini-laparotomy, at 1.4 days vs. 5.4 days for those with open hysterectomy (P = .000) as was mean estimated blood loss – 119.9 mL vs. 547.5 mL, respectively (P = .000). Postoperative complications were seen in fewer patients who underwent robotic hysterectomy/mini-laparotomy, 9 of 82 patients vs. 15 of 58 open hysterectomy patients.
Mean operative time was significantly longer in robotic hysterectomy/mini-laparotomy patients – 191.6 minutes vs. 162.8 minutes (P = .005) – but that was expected, Dr. Gupta noted. Patient factors such as hypertension, diabetes, history of spontaneous vaginal delivery and/or cesarean delivery, and body mass index, as well as uterine pathology, were not significantly different between the groups.
“Mini-laparotomy combined with minimally invasive hysterectomy is a very safe and feasible technique for tissue extraction where contained morcellation is either not preferred or not available,” Dr. Gupta said.
Dr. Gupta reported having no relevant financial conflicts of interest.
[email protected]
On Twitter @denisefulton
NATIONAL HARBOR, MD. – Robotic hysterectomy combined with extraction of the uterus via mini-laparotomy led to significantly shorter lengths of stay, lower estimated blood loss, and fewer postoperative complications compared with open hysterectomy when the uterus weighed more than 250 grams.
Gynecologic surgeons are seeking ways to safely perform minimally invasive hysterectomy on patients with larger uteri in light of the 2014 Food and Drug Administration admonition regarding power morcellation. To this end, Natasha Gupta, MD, and her colleagues at the University of Tennessee, Chattanooga, retrospectively reviewed all patients with uterine sizes larger than 250 grams undergoing hysterectomy at their institution between 2012 and 2015.
“For the mini-laparotomy, the technique utilizes a customized incision connecting the two left port sites, followed by the removal of the specimen via this incision,” Dr. Gupta said at the AAGL Global Congress.
Patient factors and outcomes were compared via Student t-tests and Chi-square analysis.
Mean length of stay was significantly shorter for patients who underwent robotic hysterectomy/mini-laparotomy, at 1.4 days vs. 5.4 days for those with open hysterectomy (P = .000) as was mean estimated blood loss – 119.9 mL vs. 547.5 mL, respectively (P = .000). Postoperative complications were seen in fewer patients who underwent robotic hysterectomy/mini-laparotomy, 9 of 82 patients vs. 15 of 58 open hysterectomy patients.
Mean operative time was significantly longer in robotic hysterectomy/mini-laparotomy patients – 191.6 minutes vs. 162.8 minutes (P = .005) – but that was expected, Dr. Gupta noted. Patient factors such as hypertension, diabetes, history of spontaneous vaginal delivery and/or cesarean delivery, and body mass index, as well as uterine pathology, were not significantly different between the groups.
“Mini-laparotomy combined with minimally invasive hysterectomy is a very safe and feasible technique for tissue extraction where contained morcellation is either not preferred or not available,” Dr. Gupta said.
Dr. Gupta reported having no relevant financial conflicts of interest.
[email protected]
On Twitter @denisefulton
NATIONAL HARBOR, MD. – Robotic hysterectomy combined with extraction of the uterus via mini-laparotomy led to significantly shorter lengths of stay, lower estimated blood loss, and fewer postoperative complications compared with open hysterectomy when the uterus weighed more than 250 grams.
Gynecologic surgeons are seeking ways to safely perform minimally invasive hysterectomy on patients with larger uteri in light of the 2014 Food and Drug Administration admonition regarding power morcellation. To this end, Natasha Gupta, MD, and her colleagues at the University of Tennessee, Chattanooga, retrospectively reviewed all patients with uterine sizes larger than 250 grams undergoing hysterectomy at their institution between 2012 and 2015.
“For the mini-laparotomy, the technique utilizes a customized incision connecting the two left port sites, followed by the removal of the specimen via this incision,” Dr. Gupta said at the AAGL Global Congress.
Patient factors and outcomes were compared via Student t-tests and Chi-square analysis.
Mean length of stay was significantly shorter for patients who underwent robotic hysterectomy/mini-laparotomy, at 1.4 days vs. 5.4 days for those with open hysterectomy (P = .000) as was mean estimated blood loss – 119.9 mL vs. 547.5 mL, respectively (P = .000). Postoperative complications were seen in fewer patients who underwent robotic hysterectomy/mini-laparotomy, 9 of 82 patients vs. 15 of 58 open hysterectomy patients.
Mean operative time was significantly longer in robotic hysterectomy/mini-laparotomy patients – 191.6 minutes vs. 162.8 minutes (P = .005) – but that was expected, Dr. Gupta noted. Patient factors such as hypertension, diabetes, history of spontaneous vaginal delivery and/or cesarean delivery, and body mass index, as well as uterine pathology, were not significantly different between the groups.
“Mini-laparotomy combined with minimally invasive hysterectomy is a very safe and feasible technique for tissue extraction where contained morcellation is either not preferred or not available,” Dr. Gupta said.
Dr. Gupta reported having no relevant financial conflicts of interest.
[email protected]
On Twitter @denisefulton
AT AAGL 2017
Key clinical point:
Major finding: Mean length of stay was 1.4 days with robotic hysterectomy/mini-laparotomy vs. 5.4 days for open hysterectomy (P = .000).
Data source: A single-center retrospective review of all hysterectomies with uteri larger than 250 grams from the period of 2012-2015.
Disclosures: The study had no outside funding. Dr. Gupta reported having no relevant conflicts of interest.
Preop endocervical sampling pathology can guide trachelectomy planning
NATIONAL HARBOR, MD. – Pathologic findings from preoperative endocervical sampling were fairly consistent with the underlying pathologies identified at trachelectomy, based on a single-center, retrospective chart review presented at the AAGL Global Congress.
“Preoperative endocervical sampling can be performed safely and adequately with results consistent with final trachelectomy pathology,” said Sarah Krantz, MD, of Vanderbilt University, Nashville, Tenn. Importantly, performing preoperative sampling may identify a missed diagnosis of cancer and allows for subsequent appropriate preoperative planning, she added.
Dr. Krantz and her colleagues included 47 women who had a supracervical hysterectomy and subsequently underwent trachelectomy at Vanderbilt from April 1999 to April 2015. Indications for surgery included vaginal bleeding (24), abnormal pap smears (7), pain (16), prolapse (13), and cancer (2). If patients had a prior diagnosis of gynecologic malignancy, they were excluded from the study.
Endocervical sampling was performed in 18 of the 47 women by a gynecologist. Samples were collected by way of various methods, including Pap smear, endocervical brushings and curettage, and endometrial pipelle. The pathologic findings in endocervical samples coincided with the final surgical pathology in 9 of 10 patients with benign findings, 1 of 6 patients with dysplasia, and 2 of 2 patients with cancer.
Among the 29 women who did not undergo preoperative endocervical sampling, one was diagnosed with cervical cancer at final surgical pathology.
In the 24 women with vaginal bleeding, cervicitis was identified in 1 of 10 patients who underwent preoperative endocervical sampling and was found on final pathology in 12 of 24 patients.Given the high incidence of cervicitis in women who report vaginal bleeding, consideration should be given for medical management prior to surgical excision, Dr. Krantz said.
Dr. Krantz reported having no relevant financial disclosures.
NATIONAL HARBOR, MD. – Pathologic findings from preoperative endocervical sampling were fairly consistent with the underlying pathologies identified at trachelectomy, based on a single-center, retrospective chart review presented at the AAGL Global Congress.
“Preoperative endocervical sampling can be performed safely and adequately with results consistent with final trachelectomy pathology,” said Sarah Krantz, MD, of Vanderbilt University, Nashville, Tenn. Importantly, performing preoperative sampling may identify a missed diagnosis of cancer and allows for subsequent appropriate preoperative planning, she added.
Dr. Krantz and her colleagues included 47 women who had a supracervical hysterectomy and subsequently underwent trachelectomy at Vanderbilt from April 1999 to April 2015. Indications for surgery included vaginal bleeding (24), abnormal pap smears (7), pain (16), prolapse (13), and cancer (2). If patients had a prior diagnosis of gynecologic malignancy, they were excluded from the study.
Endocervical sampling was performed in 18 of the 47 women by a gynecologist. Samples were collected by way of various methods, including Pap smear, endocervical brushings and curettage, and endometrial pipelle. The pathologic findings in endocervical samples coincided with the final surgical pathology in 9 of 10 patients with benign findings, 1 of 6 patients with dysplasia, and 2 of 2 patients with cancer.
Among the 29 women who did not undergo preoperative endocervical sampling, one was diagnosed with cervical cancer at final surgical pathology.
In the 24 women with vaginal bleeding, cervicitis was identified in 1 of 10 patients who underwent preoperative endocervical sampling and was found on final pathology in 12 of 24 patients.Given the high incidence of cervicitis in women who report vaginal bleeding, consideration should be given for medical management prior to surgical excision, Dr. Krantz said.
Dr. Krantz reported having no relevant financial disclosures.
NATIONAL HARBOR, MD. – Pathologic findings from preoperative endocervical sampling were fairly consistent with the underlying pathologies identified at trachelectomy, based on a single-center, retrospective chart review presented at the AAGL Global Congress.
“Preoperative endocervical sampling can be performed safely and adequately with results consistent with final trachelectomy pathology,” said Sarah Krantz, MD, of Vanderbilt University, Nashville, Tenn. Importantly, performing preoperative sampling may identify a missed diagnosis of cancer and allows for subsequent appropriate preoperative planning, she added.
Dr. Krantz and her colleagues included 47 women who had a supracervical hysterectomy and subsequently underwent trachelectomy at Vanderbilt from April 1999 to April 2015. Indications for surgery included vaginal bleeding (24), abnormal pap smears (7), pain (16), prolapse (13), and cancer (2). If patients had a prior diagnosis of gynecologic malignancy, they were excluded from the study.
Endocervical sampling was performed in 18 of the 47 women by a gynecologist. Samples were collected by way of various methods, including Pap smear, endocervical brushings and curettage, and endometrial pipelle. The pathologic findings in endocervical samples coincided with the final surgical pathology in 9 of 10 patients with benign findings, 1 of 6 patients with dysplasia, and 2 of 2 patients with cancer.
Among the 29 women who did not undergo preoperative endocervical sampling, one was diagnosed with cervical cancer at final surgical pathology.
In the 24 women with vaginal bleeding, cervicitis was identified in 1 of 10 patients who underwent preoperative endocervical sampling and was found on final pathology in 12 of 24 patients.Given the high incidence of cervicitis in women who report vaginal bleeding, consideration should be given for medical management prior to surgical excision, Dr. Krantz said.
Dr. Krantz reported having no relevant financial disclosures.
AT AAGL 2017
Key clinical point:
Major finding: Among 18 women who had preoperative endocervical sampling, the pathology results matched those of the final surgical pathology in 9 of 10 patients with benign disorders, 1 of 6 patients with dysplasia, and 2 of 2 patients with cancer.
Data source: A retrospective chart review of 47 women who underwent trachelectomy at a single academic medical center from April 1999-April 2015.
Disclosures: Dr. Krantz reported having no relevant financial disclosures.
VIDEO: Outpatient hysterectomies offer advantages for surgeons, patients
NATIONAL HARBOR, MD. – Moving hysterectomy and advanced gynecologic procedures to the ambulatory surgical environment is better for patients, surgeons, and the health care system, Richard B. Rosenfield, MD, who is in private practice in Portland, Ore., said at the AAGL Global Congress.
“We’ve been basically proving this model over the last decade by performing advanced laparoscopic surgery in the outpatient environment, and we do this for a number of reasons,” Dr. Rosenfield said in an interview. “The patients get to go home the same day, which they typically enjoy, we avoid the hospital-acquired infections, which is great, and in addition to that, the physicians tend to really appreciate the efficiency of an outpatient center.”
But with the focus on value-based payment under federal health programs, there should also be a greater focus on getting more high-volume surgeons to perform their procedures, he said. The idea is to lower the hospital readmissions, complications, and infections that could arise during procedures by less experienced surgeons and redirect the cost savings toward payments for surgeons with better outcomes, Dr. Rosenfield said. But this should be coupled with training and mentoring for lower-volume surgeons, he said.
Dr. Rosenfield reported having no relevant financial disclosures.
[email protected]
On Twitter @eaztweets
NATIONAL HARBOR, MD. – Moving hysterectomy and advanced gynecologic procedures to the ambulatory surgical environment is better for patients, surgeons, and the health care system, Richard B. Rosenfield, MD, who is in private practice in Portland, Ore., said at the AAGL Global Congress.
“We’ve been basically proving this model over the last decade by performing advanced laparoscopic surgery in the outpatient environment, and we do this for a number of reasons,” Dr. Rosenfield said in an interview. “The patients get to go home the same day, which they typically enjoy, we avoid the hospital-acquired infections, which is great, and in addition to that, the physicians tend to really appreciate the efficiency of an outpatient center.”
But with the focus on value-based payment under federal health programs, there should also be a greater focus on getting more high-volume surgeons to perform their procedures, he said. The idea is to lower the hospital readmissions, complications, and infections that could arise during procedures by less experienced surgeons and redirect the cost savings toward payments for surgeons with better outcomes, Dr. Rosenfield said. But this should be coupled with training and mentoring for lower-volume surgeons, he said.
Dr. Rosenfield reported having no relevant financial disclosures.
[email protected]
On Twitter @eaztweets
NATIONAL HARBOR, MD. – Moving hysterectomy and advanced gynecologic procedures to the ambulatory surgical environment is better for patients, surgeons, and the health care system, Richard B. Rosenfield, MD, who is in private practice in Portland, Ore., said at the AAGL Global Congress.
“We’ve been basically proving this model over the last decade by performing advanced laparoscopic surgery in the outpatient environment, and we do this for a number of reasons,” Dr. Rosenfield said in an interview. “The patients get to go home the same day, which they typically enjoy, we avoid the hospital-acquired infections, which is great, and in addition to that, the physicians tend to really appreciate the efficiency of an outpatient center.”
But with the focus on value-based payment under federal health programs, there should also be a greater focus on getting more high-volume surgeons to perform their procedures, he said. The idea is to lower the hospital readmissions, complications, and infections that could arise during procedures by less experienced surgeons and redirect the cost savings toward payments for surgeons with better outcomes, Dr. Rosenfield said. But this should be coupled with training and mentoring for lower-volume surgeons, he said.
Dr. Rosenfield reported having no relevant financial disclosures.
[email protected]
On Twitter @eaztweets
AT AAGL 2017
Higher BMI linked to lower risk of hysterectomy reoperation
NATIONAL HARBOR, MD. – Women with a greater body mass index (BMI) were less likely to need reoperation after hysterectomy, according to findings presented at the AAGL Global Congress.
“What’s unusual is women who are considered overweight or obese are generally thought to be at higher risk of any complication, including reoperation,” Janelle Moulder, MD, of the department of ob.gyn. at the University of Tennessee, Knoxville, said in an interview prior to the meeting. “We don’t have enough data to say what exactly might be protective. And to see that women who are at normal or below normal BMI were at increased risk makes you pause as to what could potentially put them at risk.”
Dr. Moulder and her colleagues analyzed data on 28,487 women who underwent an abdominal, vaginal, or laparoscopic hysterectomy from 2014 to 2015. The data came from the American College of Surgeons (ACS) National Surgical Quality Improvement Program (NSQIP) database.
Patients were excluded if they had cancer, their surgery was not performed by a gynecologist, or their BMI data was missing.
A majority of patients (13,000) had a BMI of 30 kg/m2 or greater.
Compared with patients with a normal BMI of 24 kg/m2, patients with a BMI of 39 kg/m2 had the lowest odds of reoperation (adjusted odds ratio, 0.73; P = .02). Patients with BMIs of 29 kg/m2 and 34 kg/m2 were also at lower odds of reoperation, with adjusted odds ratios of 0.83 (P = .003) and 0.75 (P = .005), respectively.
Patients with a low normal BMI of 18.5 kg/m2 were at a higher risk of reoperation (aOR = 1.33; P = .001).
Researchers were unable to comment on women with a BMI of 45 kg/m2 or greater, due to the limited number of women in this group.
Researchers did not have access to the reason for reoperation, which may have limited the scope of the study.
“The next thing to be evaluated is what is the protective effect of the increasing BMI on reoperation and also look at variables that may put low normal BMI women at risk for reoperation,” Dr. Moulder said.
The researchers reported having no relevant financial disclosures.
[email protected]
On Twitter @eaztweets
NATIONAL HARBOR, MD. – Women with a greater body mass index (BMI) were less likely to need reoperation after hysterectomy, according to findings presented at the AAGL Global Congress.
“What’s unusual is women who are considered overweight or obese are generally thought to be at higher risk of any complication, including reoperation,” Janelle Moulder, MD, of the department of ob.gyn. at the University of Tennessee, Knoxville, said in an interview prior to the meeting. “We don’t have enough data to say what exactly might be protective. And to see that women who are at normal or below normal BMI were at increased risk makes you pause as to what could potentially put them at risk.”
Dr. Moulder and her colleagues analyzed data on 28,487 women who underwent an abdominal, vaginal, or laparoscopic hysterectomy from 2014 to 2015. The data came from the American College of Surgeons (ACS) National Surgical Quality Improvement Program (NSQIP) database.
Patients were excluded if they had cancer, their surgery was not performed by a gynecologist, or their BMI data was missing.
A majority of patients (13,000) had a BMI of 30 kg/m2 or greater.
Compared with patients with a normal BMI of 24 kg/m2, patients with a BMI of 39 kg/m2 had the lowest odds of reoperation (adjusted odds ratio, 0.73; P = .02). Patients with BMIs of 29 kg/m2 and 34 kg/m2 were also at lower odds of reoperation, with adjusted odds ratios of 0.83 (P = .003) and 0.75 (P = .005), respectively.
Patients with a low normal BMI of 18.5 kg/m2 were at a higher risk of reoperation (aOR = 1.33; P = .001).
Researchers were unable to comment on women with a BMI of 45 kg/m2 or greater, due to the limited number of women in this group.
Researchers did not have access to the reason for reoperation, which may have limited the scope of the study.
“The next thing to be evaluated is what is the protective effect of the increasing BMI on reoperation and also look at variables that may put low normal BMI women at risk for reoperation,” Dr. Moulder said.
The researchers reported having no relevant financial disclosures.
[email protected]
On Twitter @eaztweets
NATIONAL HARBOR, MD. – Women with a greater body mass index (BMI) were less likely to need reoperation after hysterectomy, according to findings presented at the AAGL Global Congress.
“What’s unusual is women who are considered overweight or obese are generally thought to be at higher risk of any complication, including reoperation,” Janelle Moulder, MD, of the department of ob.gyn. at the University of Tennessee, Knoxville, said in an interview prior to the meeting. “We don’t have enough data to say what exactly might be protective. And to see that women who are at normal or below normal BMI were at increased risk makes you pause as to what could potentially put them at risk.”
Dr. Moulder and her colleagues analyzed data on 28,487 women who underwent an abdominal, vaginal, or laparoscopic hysterectomy from 2014 to 2015. The data came from the American College of Surgeons (ACS) National Surgical Quality Improvement Program (NSQIP) database.
Patients were excluded if they had cancer, their surgery was not performed by a gynecologist, or their BMI data was missing.
A majority of patients (13,000) had a BMI of 30 kg/m2 or greater.
Compared with patients with a normal BMI of 24 kg/m2, patients with a BMI of 39 kg/m2 had the lowest odds of reoperation (adjusted odds ratio, 0.73; P = .02). Patients with BMIs of 29 kg/m2 and 34 kg/m2 were also at lower odds of reoperation, with adjusted odds ratios of 0.83 (P = .003) and 0.75 (P = .005), respectively.
Patients with a low normal BMI of 18.5 kg/m2 were at a higher risk of reoperation (aOR = 1.33; P = .001).
Researchers were unable to comment on women with a BMI of 45 kg/m2 or greater, due to the limited number of women in this group.
Researchers did not have access to the reason for reoperation, which may have limited the scope of the study.
“The next thing to be evaluated is what is the protective effect of the increasing BMI on reoperation and also look at variables that may put low normal BMI women at risk for reoperation,” Dr. Moulder said.
The researchers reported having no relevant financial disclosures.
[email protected]
On Twitter @eaztweets
AT AAGL 2017
Key clinical point:
Major finding: Patients with a BMI of 39 kg/m2 less likely to need a reoperation after hysterectomy (aOR, .73; P = .02).
Data source: Retrospective study of 28,487 women who underwent a hysterectomy from 2014 to 2015 from the American College of Surgeons National Surgical Quality Improvement Program database.
Disclosures: The researchers reported having no relevant financial disclosures.
VIDEO: Innovative technology is opening doors for vaginal hysterectomy
NATIONAL HARBOR, MD. – Innovative tools for vaginal hysterectomy were in the spotlight during a surgical demonstration at the AAGL Global Congress.
“I think it’s really compelling that we use the technologies that the AAGL is known for investigating and teaching each other,” said Charles Rardin, MD, director of the robotic surgery program at Women & Infants Hospital, Providence, R.I. “It’s nice to see a renewed interest in some newer technologies and applying them to vaginal hysterectomy.”
The presentation of new tools comes as the number of vaginal hysterectomies have decreased and laparoscopic procedures are on the rise. The rate of vaginal hysterectomy in the United States has fallen from 24.8% in 1998 to 16.7% in 2010, according to the Nationwide Inpatient Sample from the Agency for Healthcare Research and Quality.
Surgeons demonstrated new tools with the intent of showing physicians that the benefits some associate with laparoscopic procedures, such as having easier access or a better sense of the uterus, can be associated with vaginal hysterectomy as well.
Advanced tools, such as a self-retaining retractor and 3-D camera systems, could make it easier to teach students by allowing more mobility and easier visual access, Dr. Rardin said in a video interview.
The tutorial ended with a demonstration of the natural orifice transluminal endoscopic surgery tool that allows laparoscopic tools to be introduced through the vaginal pathway.
All the tools exhibited at AAGL are currently available.
Dr. Rardin reported having no relevant financial disclosures.
On Twitter @eaztweets
NATIONAL HARBOR, MD. – Innovative tools for vaginal hysterectomy were in the spotlight during a surgical demonstration at the AAGL Global Congress.
“I think it’s really compelling that we use the technologies that the AAGL is known for investigating and teaching each other,” said Charles Rardin, MD, director of the robotic surgery program at Women & Infants Hospital, Providence, R.I. “It’s nice to see a renewed interest in some newer technologies and applying them to vaginal hysterectomy.”
The presentation of new tools comes as the number of vaginal hysterectomies have decreased and laparoscopic procedures are on the rise. The rate of vaginal hysterectomy in the United States has fallen from 24.8% in 1998 to 16.7% in 2010, according to the Nationwide Inpatient Sample from the Agency for Healthcare Research and Quality.
Surgeons demonstrated new tools with the intent of showing physicians that the benefits some associate with laparoscopic procedures, such as having easier access or a better sense of the uterus, can be associated with vaginal hysterectomy as well.
Advanced tools, such as a self-retaining retractor and 3-D camera systems, could make it easier to teach students by allowing more mobility and easier visual access, Dr. Rardin said in a video interview.
The tutorial ended with a demonstration of the natural orifice transluminal endoscopic surgery tool that allows laparoscopic tools to be introduced through the vaginal pathway.
All the tools exhibited at AAGL are currently available.
Dr. Rardin reported having no relevant financial disclosures.
On Twitter @eaztweets
NATIONAL HARBOR, MD. – Innovative tools for vaginal hysterectomy were in the spotlight during a surgical demonstration at the AAGL Global Congress.
“I think it’s really compelling that we use the technologies that the AAGL is known for investigating and teaching each other,” said Charles Rardin, MD, director of the robotic surgery program at Women & Infants Hospital, Providence, R.I. “It’s nice to see a renewed interest in some newer technologies and applying them to vaginal hysterectomy.”
The presentation of new tools comes as the number of vaginal hysterectomies have decreased and laparoscopic procedures are on the rise. The rate of vaginal hysterectomy in the United States has fallen from 24.8% in 1998 to 16.7% in 2010, according to the Nationwide Inpatient Sample from the Agency for Healthcare Research and Quality.
Surgeons demonstrated new tools with the intent of showing physicians that the benefits some associate with laparoscopic procedures, such as having easier access or a better sense of the uterus, can be associated with vaginal hysterectomy as well.
Advanced tools, such as a self-retaining retractor and 3-D camera systems, could make it easier to teach students by allowing more mobility and easier visual access, Dr. Rardin said in a video interview.
The tutorial ended with a demonstration of the natural orifice transluminal endoscopic surgery tool that allows laparoscopic tools to be introduced through the vaginal pathway.
All the tools exhibited at AAGL are currently available.
Dr. Rardin reported having no relevant financial disclosures.
On Twitter @eaztweets
AT AAGL 2017
Fibroids associated with lower chance of unsuspected malignancy
NATIONAL HARBOR, MD. – Women undergoing hysterectomy or myomectomy for benign indications, who also had fibroids, were less likely to have a malignant diagnosis, according to a study presented at the AAGL Global Congress.
These findings could change the conversation when it comes to counseling patients about the risks associated with morcellation, a procedure that was strongly discouraged by the FDA in 2014 due to the concern that it might have the potential to spread malignancy.
“There’s a lot of things going on in the media about morcellation and risk of malignancy at the time of benign fibroid surgery, but this research actually makes apparent the higher risk of malignancy when fibroids are not present,” Farah Alvi, MD, a second-year fellow at Northwestern University, Chicago, said in an interview. Despite the concerns regarding morcellation and malignancy, this research suggests that patients who have fibroids at time of surgery may have a lower chance of malignancy, compared with patients who have other indications for surgery, she explained.
Dr. Alvi and her colleagues studied 2,987 hysterectomy or myomectomy patients with benign indications between January 2005 and December 2014.
Among patients studied, researchers found 33 confirmed malignant or borderline tumors, 16 of 1,790 (0.89%) in the leiomyoma group and 17 of 1,197 (1.42%) in the group with other indications (P = 0.04). The malignancies/borderline tumors included three leiomyosarcomas, two endometrial sarcomas, two endometrioid adenocarcinomas, one granulose cell tumor, three smooth muscle tumors of uncertain malignant potential, three atypical leiomyoma, and one serous papillary borderline ovarian tumor.
Of those with leiomyomata, 1 in 600 patients were diagnosed with leiomyosarcoma, compared with a risk of 1 in 350 for unanticipated malignancy in general.
Patients with surgical indications of symptomatic leiomyoma had an odds ratio of 0.63 (P = .18) for diagnosis of an unanticipated malignancy, compared with those without leiomyoma, according to Dr. Alvi. The odds of malignancy were also reduced in patients with uterine sizes of 15-20 weeks (OR, 0.65; P = .43) and those with specimen sizes of 250-500 grams (OR, 0.68; P = .64).
These findings will have implications for how physicians counsel women undergoing minimally invasive hysterectomy or myomectomy, Dr. Alvi said.
“In counseling patients about morcellation, we often have quoted them an estimated risk of 1 in 458 for leiomyosarcoma, based on the FDA morcellation warnings, and one thing we can learn is that risk is actually much lower than we think it is,” Dr. Alvi said.
The findings also suggest a shift in focus toward identifying the factors that put women at higher risk for malignancy. For example, older age is one of the most significant risk factors identified in the study, she added.
Dr. Alvi reported having no relevant financial disclosures.
[email protected]
On Twitter @eaztweets
NATIONAL HARBOR, MD. – Women undergoing hysterectomy or myomectomy for benign indications, who also had fibroids, were less likely to have a malignant diagnosis, according to a study presented at the AAGL Global Congress.
These findings could change the conversation when it comes to counseling patients about the risks associated with morcellation, a procedure that was strongly discouraged by the FDA in 2014 due to the concern that it might have the potential to spread malignancy.
“There’s a lot of things going on in the media about morcellation and risk of malignancy at the time of benign fibroid surgery, but this research actually makes apparent the higher risk of malignancy when fibroids are not present,” Farah Alvi, MD, a second-year fellow at Northwestern University, Chicago, said in an interview. Despite the concerns regarding morcellation and malignancy, this research suggests that patients who have fibroids at time of surgery may have a lower chance of malignancy, compared with patients who have other indications for surgery, she explained.
Dr. Alvi and her colleagues studied 2,987 hysterectomy or myomectomy patients with benign indications between January 2005 and December 2014.
Among patients studied, researchers found 33 confirmed malignant or borderline tumors, 16 of 1,790 (0.89%) in the leiomyoma group and 17 of 1,197 (1.42%) in the group with other indications (P = 0.04). The malignancies/borderline tumors included three leiomyosarcomas, two endometrial sarcomas, two endometrioid adenocarcinomas, one granulose cell tumor, three smooth muscle tumors of uncertain malignant potential, three atypical leiomyoma, and one serous papillary borderline ovarian tumor.
Of those with leiomyomata, 1 in 600 patients were diagnosed with leiomyosarcoma, compared with a risk of 1 in 350 for unanticipated malignancy in general.
Patients with surgical indications of symptomatic leiomyoma had an odds ratio of 0.63 (P = .18) for diagnosis of an unanticipated malignancy, compared with those without leiomyoma, according to Dr. Alvi. The odds of malignancy were also reduced in patients with uterine sizes of 15-20 weeks (OR, 0.65; P = .43) and those with specimen sizes of 250-500 grams (OR, 0.68; P = .64).
These findings will have implications for how physicians counsel women undergoing minimally invasive hysterectomy or myomectomy, Dr. Alvi said.
“In counseling patients about morcellation, we often have quoted them an estimated risk of 1 in 458 for leiomyosarcoma, based on the FDA morcellation warnings, and one thing we can learn is that risk is actually much lower than we think it is,” Dr. Alvi said.
The findings also suggest a shift in focus toward identifying the factors that put women at higher risk for malignancy. For example, older age is one of the most significant risk factors identified in the study, she added.
Dr. Alvi reported having no relevant financial disclosures.
[email protected]
On Twitter @eaztweets
NATIONAL HARBOR, MD. – Women undergoing hysterectomy or myomectomy for benign indications, who also had fibroids, were less likely to have a malignant diagnosis, according to a study presented at the AAGL Global Congress.
These findings could change the conversation when it comes to counseling patients about the risks associated with morcellation, a procedure that was strongly discouraged by the FDA in 2014 due to the concern that it might have the potential to spread malignancy.
“There’s a lot of things going on in the media about morcellation and risk of malignancy at the time of benign fibroid surgery, but this research actually makes apparent the higher risk of malignancy when fibroids are not present,” Farah Alvi, MD, a second-year fellow at Northwestern University, Chicago, said in an interview. Despite the concerns regarding morcellation and malignancy, this research suggests that patients who have fibroids at time of surgery may have a lower chance of malignancy, compared with patients who have other indications for surgery, she explained.
Dr. Alvi and her colleagues studied 2,987 hysterectomy or myomectomy patients with benign indications between January 2005 and December 2014.
Among patients studied, researchers found 33 confirmed malignant or borderline tumors, 16 of 1,790 (0.89%) in the leiomyoma group and 17 of 1,197 (1.42%) in the group with other indications (P = 0.04). The malignancies/borderline tumors included three leiomyosarcomas, two endometrial sarcomas, two endometrioid adenocarcinomas, one granulose cell tumor, three smooth muscle tumors of uncertain malignant potential, three atypical leiomyoma, and one serous papillary borderline ovarian tumor.
Of those with leiomyomata, 1 in 600 patients were diagnosed with leiomyosarcoma, compared with a risk of 1 in 350 for unanticipated malignancy in general.
Patients with surgical indications of symptomatic leiomyoma had an odds ratio of 0.63 (P = .18) for diagnosis of an unanticipated malignancy, compared with those without leiomyoma, according to Dr. Alvi. The odds of malignancy were also reduced in patients with uterine sizes of 15-20 weeks (OR, 0.65; P = .43) and those with specimen sizes of 250-500 grams (OR, 0.68; P = .64).
These findings will have implications for how physicians counsel women undergoing minimally invasive hysterectomy or myomectomy, Dr. Alvi said.
“In counseling patients about morcellation, we often have quoted them an estimated risk of 1 in 458 for leiomyosarcoma, based on the FDA morcellation warnings, and one thing we can learn is that risk is actually much lower than we think it is,” Dr. Alvi said.
The findings also suggest a shift in focus toward identifying the factors that put women at higher risk for malignancy. For example, older age is one of the most significant risk factors identified in the study, she added.
Dr. Alvi reported having no relevant financial disclosures.
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AT AAGL 2017
Key clinical point:
Major finding: Patients with preoperative indication of symptomatic leiomyoma had an odds ratio of 0.63 (P = .18) of having a diagnosis of malignancy.
Data source: Retrospective study of 2,987 hysterectomies or myomectomies between January 2005 and December 2014.
Disclosures: Dr. Alvi reported having no relevant financial disclosures.