Ranica Arrowsmith, Associate Editor04.07.16
On the U.S. Food and Drug Administration’s website today is a spotlight on Essure, a form of permanent birth control. Inserted by a physician into the fallopian tubes, the channels through which eggs travel when released from the ovaries, Essure is currently the only permanent birth control that is non surgical. After a period of about three months, tissue grows around the inserts, preventing sperm from entering the tubes. The device, which is made by German medical product giant Bayer AG, seems like the answer to many women’s prayers at first blush. Non surgical, non hormonal, and permanent—what could be easier?
Well, it turns out that Essure isn’t that easy. The reason the FDA is bringing public attention to the device is that enough concern has been raised about Essure’s safety to make the agency worried. In fact, taking on Essure is famed civil activist Erin Brokovich’s latest project.
“Over the past several years, the FDA has been examining the growing number of adverse event reports associated with the use of Essure,” the agency stated on its website. “Reported adverse events include persistent pain, perforation of the uterus and/or fallopian tubes, intra-abdominal or pelvic device migration, abnormal or irregular bleeding, and allergy or hypersensitivity reactions. Some women have had surgical procedures to remove the device. In addition, Essure failure, and, in some cases, incomplete patient follow-up, have resulted in unintended pregnancies.”
Out of these, I would argue that the most worrisome is the “incomplete patient follow-up.” The FDA lists 19 categories of birth control that it recommends for public health. Of these 19, only two methods are targeted at men—male condoms (non permanent) and vasectomies (semi permanent). By targeting birth control primarily at women, medtech has made women the proprietors; the gatekeepers; the responsible party for pregnancy.
It must be noted here that there is male hormonal birth control—it exists. However, the long history of female-focused birth control has created an environment where there is not much demand for male birth control, so companies don’t see profit in the endeavor. Companies such as Schering were pumping millions into the development of male birth control, until it was bought by—you guessed it—Bayer. That lack of demand, combined with the social reality that men are more resistant to physician visits and not as good at paying attention to personal health in general bolsters the self-fulfilling cycle of women being placed in charge of reproductive health for both sexes.
While it is true that women are the sex that is giving birth and bearing most of the pain and suffering that comes from unintended pregnancies (no sense in denying it), it takes two to cause the “accident.” Focusing birth control methods on women in such overwhelming ratios is one of many sociopolitical factors that place the weight of responsibility primarily on women’s shoulders. But if this is our reality, why then is there not adequate care given to women (in the form of responsible follow ups after the use of a device like Essure) upon whom we place societal blame for unwanted pregnancies?
According to a New England Journal of Medicine article from October 2015, premarket Essure studies were woefully inadequate in terms of follow-up with patients.
“Although Essure is designed to remain in place for a woman's lifetime, few women in the premarketing studies were followed for more than 1 year—a limitation that precludes conclusions about longer-term risks,” the authors wrote. “Appropriately, FDA approval was conditional on two mandatory postapproval studies to provide 5-year follow-up data on patients in the premarketing approval studies. However, these studies were not made well known: neither one was registered at ClinicalTrials.gov (though that probably wasn't legally required under the FDA Modernization Act) and their results were not disseminated in a timely way. One postapproval study remains unpublished, and the other was published only recently—13 years after device approval and 7 years after study completion and reporting to the FDA.”
No one is here to trash the FDA—I actually wrote about how much the agency does in the interest of public safety here—but in the particular corner of women’s health, the overall landscape of care is not as adequate as it should be. Part of the reason was highlighted in an explosive Nature article from 2014, which described how while the National Institutes of Health founded the Office of Research on Women's Health (ORWH) to rectify the lack of representation of women in clinical trials, animal trials continued to constitute only of male rats, because dealing with female hormonal cycles was too troublesome to deal with in a carefully calibrated trial. The obvious repercussions are that drug and device effects in women did not (and still do not) have as much data behind them as their effects on men.
The healthcare landscape has determined, via its practices, that women’s health is second-class, even though socially, we know that women’s health is of paramount importance to the health of society. We have the medical field of gynecology which is meant to preserve women’s health; we have countless organizations dedicated to educating women about their health; Planned Parenthood was founded to provide hard-to-access services to women who needed them; and yet, we don’t reflect this knowledge at the beginning point of clinical research.
Female birth control, of course, is tested in female animals. What we now refer to colloquially as “the birth control pill”—a pill containing estrogen and progestogen—was first tested in female rabbits and rats to prevent ovulation. The Essure clinical trial, though, failed to consider long-term effects of the device, despite it being touted as a “permanent” form of birth control.
Evidence can be counted as “anecdotal” if it amounted only to a collection of individual stories from patients. But when those stories start to number in the thousands, as they have, the socially responsible thing to do is to pay attention. Not all of these stories may end up in an adverse event report to the FDA, either:
“In December of 2010, I had the Essure procedure,” a user identified as “Melissa” on Erin Brokovich’s patient advocacy site said. “My Gyn performed this at a local hospital. She was able to implant one spring into my left fallopian tube, but not the right (thank God). For 3 years, I was plagued with reoccurring left lower quadrant pain. Pain that was severe enough to have me going to the ER at least three times. Each time, doctors claimed they could find nothing wrong. As an ultrasound tech, I was able to scan myself, and see that this spring appeared to move.”
If physicians find nothing wrong, the adverse event will go unreported.
Nonetheless, the FDA has received many adverse event reports—enough for it to warn the public about the possible dangers surrounding Essure. The agency had a meeting of the Gynecology Devices Panel of the Medical Devices Advisory Committee in September last year to hear testimony from both expert scientists and clinicians, as well as patients, regarding the benefits and risks of Essure. The FDA also received more than 2,800 comments in a public docket soliciting opinions.
After all of this postmarket evaluation, FDA has ordered Bayer to conduct a postmarket surveillance study to obtain more data on Essure. The agency also intends to include a boxed warning and Patient Decision Checklist to the product labeling to help ensure that a woman receives and understands information regarding the benefits and risks of this type of device. In addition, FDA issued the draft guidance, “Labeling for Permanent Hysteroscopically-Placed Tubal Implants Intended for Sterilization” to provide the public an opportunity to comment on the proposed language to be included in these warnings. Finally, the agency is in the process of completing its evaluation of the trade complaint against Essure.
As it turns out, medical device companies don’t push for male birth control because it is not profitable—but a lucrative market such as female birth control only encourages companies to rush a little too fast to get to market. In a landscape where women have been forced into the role of gatekeeper of societal sexual health, there needs to be more corporate and government care taken to ensure women are protected in that role.
Well, it turns out that Essure isn’t that easy. The reason the FDA is bringing public attention to the device is that enough concern has been raised about Essure’s safety to make the agency worried. In fact, taking on Essure is famed civil activist Erin Brokovich’s latest project.
“Over the past several years, the FDA has been examining the growing number of adverse event reports associated with the use of Essure,” the agency stated on its website. “Reported adverse events include persistent pain, perforation of the uterus and/or fallopian tubes, intra-abdominal or pelvic device migration, abnormal or irregular bleeding, and allergy or hypersensitivity reactions. Some women have had surgical procedures to remove the device. In addition, Essure failure, and, in some cases, incomplete patient follow-up, have resulted in unintended pregnancies.”
Out of these, I would argue that the most worrisome is the “incomplete patient follow-up.” The FDA lists 19 categories of birth control that it recommends for public health. Of these 19, only two methods are targeted at men—male condoms (non permanent) and vasectomies (semi permanent). By targeting birth control primarily at women, medtech has made women the proprietors; the gatekeepers; the responsible party for pregnancy.
It must be noted here that there is male hormonal birth control—it exists. However, the long history of female-focused birth control has created an environment where there is not much demand for male birth control, so companies don’t see profit in the endeavor. Companies such as Schering were pumping millions into the development of male birth control, until it was bought by—you guessed it—Bayer. That lack of demand, combined with the social reality that men are more resistant to physician visits and not as good at paying attention to personal health in general bolsters the self-fulfilling cycle of women being placed in charge of reproductive health for both sexes.
While it is true that women are the sex that is giving birth and bearing most of the pain and suffering that comes from unintended pregnancies (no sense in denying it), it takes two to cause the “accident.” Focusing birth control methods on women in such overwhelming ratios is one of many sociopolitical factors that place the weight of responsibility primarily on women’s shoulders. But if this is our reality, why then is there not adequate care given to women (in the form of responsible follow ups after the use of a device like Essure) upon whom we place societal blame for unwanted pregnancies?
According to a New England Journal of Medicine article from October 2015, premarket Essure studies were woefully inadequate in terms of follow-up with patients.
“Although Essure is designed to remain in place for a woman's lifetime, few women in the premarketing studies were followed for more than 1 year—a limitation that precludes conclusions about longer-term risks,” the authors wrote. “Appropriately, FDA approval was conditional on two mandatory postapproval studies to provide 5-year follow-up data on patients in the premarketing approval studies. However, these studies were not made well known: neither one was registered at ClinicalTrials.gov (though that probably wasn't legally required under the FDA Modernization Act) and their results were not disseminated in a timely way. One postapproval study remains unpublished, and the other was published only recently—13 years after device approval and 7 years after study completion and reporting to the FDA.”
No one is here to trash the FDA—I actually wrote about how much the agency does in the interest of public safety here—but in the particular corner of women’s health, the overall landscape of care is not as adequate as it should be. Part of the reason was highlighted in an explosive Nature article from 2014, which described how while the National Institutes of Health founded the Office of Research on Women's Health (ORWH) to rectify the lack of representation of women in clinical trials, animal trials continued to constitute only of male rats, because dealing with female hormonal cycles was too troublesome to deal with in a carefully calibrated trial. The obvious repercussions are that drug and device effects in women did not (and still do not) have as much data behind them as their effects on men.
The healthcare landscape has determined, via its practices, that women’s health is second-class, even though socially, we know that women’s health is of paramount importance to the health of society. We have the medical field of gynecology which is meant to preserve women’s health; we have countless organizations dedicated to educating women about their health; Planned Parenthood was founded to provide hard-to-access services to women who needed them; and yet, we don’t reflect this knowledge at the beginning point of clinical research.
Female birth control, of course, is tested in female animals. What we now refer to colloquially as “the birth control pill”—a pill containing estrogen and progestogen—was first tested in female rabbits and rats to prevent ovulation. The Essure clinical trial, though, failed to consider long-term effects of the device, despite it being touted as a “permanent” form of birth control.
Evidence can be counted as “anecdotal” if it amounted only to a collection of individual stories from patients. But when those stories start to number in the thousands, as they have, the socially responsible thing to do is to pay attention. Not all of these stories may end up in an adverse event report to the FDA, either:
“In December of 2010, I had the Essure procedure,” a user identified as “Melissa” on Erin Brokovich’s patient advocacy site said. “My Gyn performed this at a local hospital. She was able to implant one spring into my left fallopian tube, but not the right (thank God). For 3 years, I was plagued with reoccurring left lower quadrant pain. Pain that was severe enough to have me going to the ER at least three times. Each time, doctors claimed they could find nothing wrong. As an ultrasound tech, I was able to scan myself, and see that this spring appeared to move.”
If physicians find nothing wrong, the adverse event will go unreported.
Nonetheless, the FDA has received many adverse event reports—enough for it to warn the public about the possible dangers surrounding Essure. The agency had a meeting of the Gynecology Devices Panel of the Medical Devices Advisory Committee in September last year to hear testimony from both expert scientists and clinicians, as well as patients, regarding the benefits and risks of Essure. The FDA also received more than 2,800 comments in a public docket soliciting opinions.
After all of this postmarket evaluation, FDA has ordered Bayer to conduct a postmarket surveillance study to obtain more data on Essure. The agency also intends to include a boxed warning and Patient Decision Checklist to the product labeling to help ensure that a woman receives and understands information regarding the benefits and risks of this type of device. In addition, FDA issued the draft guidance, “Labeling for Permanent Hysteroscopically-Placed Tubal Implants Intended for Sterilization” to provide the public an opportunity to comment on the proposed language to be included in these warnings. Finally, the agency is in the process of completing its evaluation of the trade complaint against Essure.
As it turns out, medical device companies don’t push for male birth control because it is not profitable—but a lucrative market such as female birth control only encourages companies to rush a little too fast to get to market. In a landscape where women have been forced into the role of gatekeeper of societal sexual health, there needs to be more corporate and government care taken to ensure women are protected in that role.