On April 9, yet another victory was scored as the FDA issued an order restricting the sale and distribution of the Essure device. Not recalled. Not banned. Restricted. Frustrating? Yes. A step in the right direction? Most definitely. Below, you’ll find the FDA’s press release announcing the new order.
They say the wheels of progress turn slowly. When it comes to protecting women’s health, those wheels move at glacial speeds. It can be discouraging to see other issues – such as a focus on speeding up the already too fast medical device approval process – getting attention while women suffer, and even die, as a result of a medical device that was approved under dubious circumstances. Often, victories in the area of protecting our mothers, daughters, wives, girlfriends, aunts, friends, and all women appear to be small at best. That is because they often are, despite being victories. Years have passed with tens of thousands of injured women and those who stand with them fighting to get Essure, Bayer’s “permanent” birth control device off the market. Most, if not all, of the changes to the way this device is marketed have come as a result of the banding together of these injured women – the E-Sisters – and their supporters. The government itself has been very lax in living up to its responsibility to protect women’s health. The fight has seen victories such as a Black Box Warning being added, as well as a patient checklist, both of which promised to further inform women of the risks of using the Essure device.
Yes, those were victories. Did they help, though? Not, unfortunately, as much as one would hope. Many women are still being sold on Essure without ever seeing either the Black Box Warning or the patient checklist. In short, they are undergoing this procedure without true and adequate informed consent. On April 9, yet another victory was scored as the FDA issued an order restricting the sale and distribution of the Essure device. Not recalled. Not banned. Restricted. Frustrating? Yes. A step in the right direction? Most definitely. Below, you’ll find the FDA’s press release announcing the new order.
“The U.S. Food and Drug Administration today issued an order to restrict the sale and distribution of the Essure device to ensure that all women considering use of the permanent contraception device are provided with adequate risk information so that they can make informed decisions. The FDA is taking this step after becoming aware that some women were not being adequately informed of Essure’s risks before getting the device implanted, despite previous significant efforts to educate patients and doctors about the risks associated with this device. The FDA is requiring a unique type of restriction, using its authority to restrict the sale and distribution of a device to impose additional requirements needed to provide a reasonable assurance of its safety and effectiveness. The FDA is committed to continuing to use its full authorities to ensure the post-market safety of medical products.
Since the FDA ordered Bayer to conduct a post-market study, and then to add a boxed warning and a patient decision checklist to the labeling, there has been an approximately 70 percent decline in sales of Essure in the U.S. The FDA has determined, however, that some women still are not receiving information about the known risks of Essure before implantation.
‘We’ve been closely evaluating new information on the use of Essure, and based on our review of a growing body of evidence, we believe this product requires additional, meaningful safeguards to ensure women are able to make informed decisions about risk when considering this option,’ said FDA Commissioner Scott Gottlieb, M.D. ‘We take the concerns of all women affected by Essure very seriously. I’ve personally had the opportunity to meet with several women and hear their important concerns about this product. Despite previous efforts to alert women to the potential complications of Essure, we know that some patients still aren’t receiving this important information. That is simply unacceptable. Every single woman receiving this device should fully understand the associated risks.’” [Editor’s note: The E-Sisters are the reason for this remarkable new FDA approach. Their grassroots efforts have made change possible.]
“The new Essure labeling, which will now be legally required when this product is offered to a patient, restricts the sale and distribution of the device to only health care providers and facilities that provide information to patients about the risks and benefits of this device. Specifically, the patient brochure, titled “Patient-Doctor Discussion Checklist – Acceptance of Risk and Informed Decision Acknowledgement,” must be reviewed with the prospective patient by the health care provider to ensure the patient understands the risks, benefits and other information about Essure implantation. The patient must be given the opportunity to sign the acknowledgment, and it must be signed by the physician implanting the device. Bayer, the device manufacturer, is required to implement the restrictions immediately and ensure that the process going forward results in health care provider compliance with the sales restriction. The FDA will review and monitor Bayer’s plan to ensure the company complies with the restriction. The FDA plans to enforce these requirements and will take appropriate action for a failure to comply, including applicable criminal and civil penalties.
Essure is the only permanently implanted birth control device for women on the market that does not require a surgical incision. In the procedure, a health care provider inserts flexible coils through the vagina and cervix and into the fallopian tubes – the tubes that carry the eggs from the ovaries to the uterus. Over a period of approximately three months, tissue forms around the inserts. The build-up of tissue creates a barrier that keeps sperm from reaching the eggs, thus preventing conception. Some patients implanted with Essure have experienced adverse events, including perforation of the uterus and/or fallopian tubes, migration of inserts to the abdominal or pelvic cavity, persistent pain and suspected allergic or hypersensitivity reactions. In addition, women have also reported experiencing headache, fatigue, weight changes, hair loss and mood changes, such as depression. It is unknown whether these symptoms are related to Essure.
‘Ensuring informed decision making is just one important step in our ongoing efforts to monitor this device. We remain committed to carefully and thoroughly considering all new data and evidence and will continue to work with patients affected by this device as part of our process,’ said Terri Cornelison, M.D., Ph.D., assistant director for the health of women in the FDA’s Center for Devices and Radiological Health. ‘While some women may continue to choose Essure as their birth control option based on current information, as new information becomes available, the FDA will continue to keep the public informed of the agency’s evaluation and findings, and consider regulatory options that appropriately balance benefits and risks for Essure.’
Since Essure’s approval in 2002, the agency has continued to monitor the product’s safety and effectiveness by reviewing the medical literature, clinical trial information, post-approval study data and medical device reports submitted to the agency. Based on this review, in February 2016, the agency ordered Bayer to conduct a post-marketing (522) study to better evaluate the safety profile of the device when used in the real world. The agency is currently monitoring the company’s progress. In November 2016, the FDA also required Bayer to add a boxed warning to the product labeling stating information about adverse events associated with the device ‘including perforation of the uterus and/or fallopian tubes, identification of inserts in the abdominal or pelvic cavity, persistent pain, and suspected allergic or hypersensitivity reactions.’
In addition to the warning, the FDA also required a more comprehensive patient decision checklist be added to the device labeling to provide women considering Essure information about the benefits and risks of this device before deciding to use it. Although Bayer’s post-market study currently has demonstrated adequate progress,” [Editor’s note: As of 10/19/17, only 136 participants (out of a necessary 2,800) and 44 study sites have been enrolled.] “including tripling of the total number of enrolled patients over the past six months, the FDA plans to require Bayer to increase the number of participating study sites to account for the declining sales volume.
The FDA is committed to continuing to communicate publicly on this issue and will provide updates related to the safety of Essure when available.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.”
While it is a step in the right direction, not all advocates for Essure’s removal necessarily believe it is without problems. Dr. Diana Zuckerman, President of the National Center for Health Research, issued a statement expressing legitimate concerns about the FDA’s decision.
She wrote, “The FDA’s decision is an effort to guarantee that women considering Essure are informed of the risks. If that is effective, it is an important step. However, there are clear problems with the checklist that is intended to help women make an informed decision. The first, obvious problem is that the checklist is part of a Patient Booklet written by Bayer that is 22 pages long. The checklist should be provided separately from the rest of the booklet, because any health communication expert can tell you that most patients will not read a 22-page document before signing it.
Equally important, much of the information provided in the booklet and in the checklist is based on data that have been questioned by experts in the field. That is why a well-designed long-term study of women who underwent Essure sterilization compared to tubal ligation is so important – and long overdue.”
One finds Dr. Zuckerman’s concerns compelling. Especially given the obvious reluctance of many implanting physicians to provide informed consent, what is to stop them from glossing over the document, downplaying the concerns, or rushing patients to read and sign? Not very much, truth be told. Yet, it is a step in the right direction. Especially if the FDA actually keeps it word on enforcing the new restriction.
As reported by CTV News, the FDA believes sales of the Essure device have plummeted by 70% after news of the Black Box Warning and patient checklist became public.
This is a good sign. The U.S. is the only market in which the Essure device is still available. It has been pulled from every world market with Bayer citing “commercial reasons”, which is a sanitized way of saying “no one wanted it and we weren’t making any money.” One cannot help but believe that the grassroots efforts made by women to protect women are the cause of these “commercial reasons.” As sad as it may sound, perhaps hitting Bayer in the bank account is the only way it will pull Essure from the market here. If so, the effort is off to a great start.
CTV News also reported that “Bayer faces lawsuits from approximately 16,000 U.S. women who have received Essure, according to the German conglomerate’s latest annual report. While the company is insured against product liability lawsuits, the [sic] Bayer notes that the claims ‘exceed the available insurance coverage.’” Sounds like the start of some compelling “commercial reasons” to pull the device from the market to me.
It remains to be seen what will happen next. Will the new FDA order be enforced? One hopes so. What is certain is that change is possible (and coming!) based on the tireless efforts of the E-Sisters, a group of injured, but powerful, women who are committed to seeing justice done.
Sources:
U.S. FDA puts restrictions on Essure birth control implant but no recall
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