On Friday, July 20, Bayer Healthcare announced it will stop selling Essure®, a metal, spring-like contraceptive device that is wound with synthetic fibers. The device was permanently implanted into the fallopian tubes of hundreds of thousands of women around the country. The withdrawal of Essure from the market is a testament to our clients and all of the other thousands of women who have been battling against Bayer to get this product off the market. Sadly, it’s too late for so many to avoid extreme pain, forced hysterectomies and the many other severe side effects and complications the FDA has recognized that Essure may cause.
In September 2015, an FDA Advisory Committee heard heartbreaking stories of Essure’s impact on women’s lives. You may read more on the hearing in my previous blog post: Takeaways from the FDA Public Hearing on Bayer’s Essure Device.
This news is particularly significant because it is quite rare that a medical device manufacturer completely stops sales of a device following complaints. As lead counsel for Essure litigation coordinated in California state court, I know many women and their loved ones who have questions about what this means. Here are my thoughts on some of the top questions I’m hearing.
1. If I have an Essure device, should I have it removed as soon as possible?
Anyone with an Essure device should consult with their doctor about the best course of action to take. Each patient is different. Continue to monitor and be in tune with your body and aware of potential complications and side effects other women have reported with Essure. If you suspect that you may be experiencing complications, contact your doctor as soon as possible.
2. Why did the FDA allow Essure sales to continue for as long as they did?
First, I don’t believe Essure should have been approved for use at all. The FDA approved Essure, claiming that it had received the “most stringent review prior to marketing.” Sadly, that clearly wasn’t the case and instead the FDA approved Essure without prior clinical studies and thereby fully examining the potential health risks versus the rewards that Conceptus (which was acquired by Bayer in 2013) was touting.
After the FDA approves a medical device like Essure for sale, it relies on the manufacturer to be honest and to provide it with complete information that it has about the safety and efficacy of its product. Manufacturers are required to tell the FDA when it has received complaints from patients and physicians about complications that may be associated with the medical device. Then the FDA launches an initial review process to determine whether an in-depth investigation is needed. Based on the findings of an investigation, the FDA may decide to pursue corrective and preventive action to address the issue.
In this case, thousands of injured women allege that Bayer did not fulfill its reporting requirements and failed to disclose information to the FDA about complaints it had received from patients and doctors. It was not until patients could report their own experiences to the FDA directly that the FDA was alerted to the fact that they had experienced significant complications they attributed to Essure. The FDA responded to these complaints by taking several steps over the course of recent years to attempt to mitigate the potential harm. For example, following the above-mentioned September 2015 hearing, the FDA ordered a rare black box warning – the FDA’s highest warning level reserved for products that may cause death or serious injury – for Essure in October 2016. The FDA heard firsthand accounts from impacted women in a February 2018 hearing, and two months later, in April 2018, the FDA announced that it would impose “unique” restrictions requiring patients and physicians to sign official documents assuring that women were fully informed of the potential dangers before being implanted with the device. The FDA said at the time that by imposing this rule, it hoped to address concerns that women weren’t being “adequately informed” on known dangers associated with Essure.
...We will be right there alongside our clients and thousands of others who seek to work to hold them responsible. In the meantime, Essure’s removal from the market is a long-awaited step in the right direction to cap the number of women who will suffer effects caused by Essure. - Fidelma L. Fitzpatrick
Bayer’s latest announcement that it plans to cease sales of Essure in the U.S. by the end of 2018 came within months of the FDA’s latest restrictions going into effect. In the time since the restrictions were imposed, the FDA reports Bayer has seen a decline of roughly 70 percent in Essure sales in the U.S.
The medical manufacturer claims that it decided to stop sales for “commercial reasons,” but the recent chain of events was undoubtedly sparked by the advocacy of injured women who made their voices heard. Their actions and that of the FDA have improved contraceptive safety for countless women moving forward. Again, unfortunately, it comes too late for women who already suffered life-altering injuries and complications in the 16 years since the FDA first approved Essure in 2002.
3. How can we prevent similar situations from happening before it is too late?
Moving forward, the FDA has said it “will remain vigilant in protecting patients who’ve already had this device implanted. We’ll continue to monitor adverse events reported to our database, as well as other data sources. And we’ll communicate publicly on any new findings or concerns.”
However, the FDA should apply more heightened monitoring for all medical products, not just Essure. If you or a loved one are experiencing unusual side effects from a medical drug or device, consult with your doctor and make sure to also notify the FDA. Doing so could alert the FDA to unknown complications, and offer insight on whether changes to the product’s warning label are necessary. The sooner a volume of complaints are reported to the FDA, the agency is put on notice and the lengthy product review process will begin.
Reports can be sent to the FDA, by you or your doctor 24 hours a day, by phone, mail and online. Visit the FDA online to complete a voluntary reporting form, or for more information on how to file a report.
4. Does this mean that women who have claims against Bayer will have an easier time proving their claims?
Despite pulling Essure from the market, Bayer continues to deny that the device is dangerous. In a statement announcing Essure’s removal, Bayer maintained that, “Several factors have contributed to declining interest in Essure among women in the U.S., including decreased use of permanent contraception overall, increased reliance on other birth control options, such as long-acting reversible contraceptives (LARCs), and inaccurate and misleading publicity about the device.” In other words, it seems that in Bayer’s eyes, women and subsequent media raising awareness about their issues are to blame.
Again, regardless of Bayer’s position, it is my firm belief that the women who have chosen to speak out about Essure should be commended. When FDA Commissioner Scott Gottlieb released a statement on Bayer’s decision, he acknowledged the major role that the victims played in raising awareness on the issue, including bringing the extent of their complications to the FDA’s attention. “In February, I personally had the opportunity to meet with women who have been adversely affected by Essure to listen and learn about their concerns. Some of the women I spoke with developed significant medical problems that they ascribe to their use of the product,” Gottlieib said.
This chain of events in recent months, including collective efforts from the FDA and injured women to increase safety is an example of how the system should work. While I believe Essure never should have entered the market, this recent outcome highlights the collective power that patients have when they speak up about the dangers of medical products and the adverse effects they’ve suffered. It highlights how crucial it is that the FDA not only show a willingness to listen to patients, but that it act, without delay, when it becomes apparent that a product is dangerous.
Bayer has indicated that it will continue to fight these lawsuits. While this outcome’s effect on pending and future litigation against Bayer remains to be seen, we will be right there alongside our clients and thousands of others who seek to work to hold them responsible. In the meantime, Essure’s removal from the market is a long-awaited step in the right direction to cap the number of women who will suffer effects caused by Essure.