Essure and Challenges in Contraceptive Choice

March 14, 2016

And sometimes, so does the Food and Drug Administration (FDA). Last September, the FDA convened an official Advisory Committee meeting on the safety of Essure, a sterilization device the FDA approved in 2002. The agency called this meeting in response to a grassroots campaign organized by women who believe that they have experienced serious complications as a result of having the device implanted. This move, while not unprecedented, is unusual for the FDA. The agency is much more likely to convene Advisory Committee meetings to re-assess previously approved products at the request of other Federal agencies, or in response to the publication of striking new data. This time, the FDA was prompted to act by the self-reports of thousands of women.

Essure is a non-surgical, non-hormonal sterilization method. It consists of two implantable inserts made of nickel-titanium alloy and stainless steel, which are inserted into the woman’s fallopian tubes through her cervix. (See image.) Once implanted, scar tissue grows around the inserts, and eventually permanently blocks the fallopian tubes. This blockage prevents sperm from connecting with the woman’s egg, preventing fertilization and pregnancy. Three months after the implant’s placement, women are expected to have a procedure to confirm the device was properly placed and the fallopian tubes are completely blocked. (Women are instructed to use another form of birth control until the blockage is confirmed.) Essure can be implanted in as little as 10 minutes in a physician’s office, and does not require an incision or general anesthesia.

When the FDA first considered Essure, in 2002, the method was welcomed by the reproductive health community because it offered women a new option for permanent birth control, other than surgical tubal ligation. In fact, the NWHN testified before the FDA in support of Essure’s approval. Our testimony noted the importance of broadening the array of safe and effective permanent birth control options. We did raise some concerns, though, as the device had been tested in a relatively small number of women for a short time-frame. We recommended that the FDA require the sponsor to put in place a written informed consent process to ensure that women fully understood the risks and the unknowns that are associated with the procedure.

At the 2002 meeting, the FDA Advisory Committee voted 8-0 (with 1 abstention) to recommend approval for Essure, with some conditions. These included requiring the drug manufacturer to follow the clinical trial participants for five years; conduct additional studies to evaluate how often the inserts were not successfully implanted; and require physicians who implant Essure to meet certain professional standards.

Following that meeting, the manufacturer began marketing Essure as a permanent birth control method that is simpler and quicker than traditional tubal ligation. Bayer, Essure’s current manufacturer, claims that over 750,000 devices have been sold to date.

Unfortunately, despite high hopes, Essure has been getting publicity for all the wrong reasons. More than 5,000 women have reported to the FDA that they’ve experienced problems after having Essure implanted. Many of the reports describe serious and disabling problems including pelvic pain, autoimmune and neurological disorders, and even uterine rupture. Neither the original nor the current manufacturer of Essure has done the type of study necessary to explore whether these problems are actually caused by Essure, and if so, to determine how likely they are to occur.  However, a new study provides solid evidence that women who receive Essure are more likely to need follow-up for problems after the procedure, compared to women who chose tubal ligation.1,2 Researchers found that women using Essure were 10 times more likely to need reoperation during their first year, compared to those who chose minimally invasive surgery for sterilization.

An online Facebook support group, “Essure Problems,” has developed into a full-fledged grassroots advocacy campaign. The group has an impressive 24,000 members including both women who have been harmed by Essure, and those who support them. Calling themselves the “E-sisters,” this community is working to raise awareness about Essure’s dangers, revoke its approval, and get Essure off the market. It was the E-sisters’ advocacy over several years that led to the FDA holding the Advisory Committee meeting in September.

At that meeting, more than 40 women testified about the pain they have endured since receiving Essure and advocated for its removal from the market. Many women described having to undergo a hysterectomy due to extreme pain and other related symptoms from the Essure device. In the NWHN’s testimony, we publicly applauded these brave women for sharing their personal stories. We told the FDA that we support a change in the device labeling and patient information guide to include information about women’s experiences. (This would be an unusual step for the FDA, however, since the information did not stem from a clinical trial.)

We also intently listened to the E-sisters’ accounts of gynecological, neurological, and autoimmune disorder pain. One of the NWHN’s guiding values is that our health care system should reflect women’s lived experiences. Women’s reports of pain, discomfort, and distress are valid and should be investigated, even if these adverse effects were not apparent during the initial clinical trials.  We don’t know if Essure caused all of these problems, but we do believe that the women who have experienced complications after receiving Essure deserve a meaningful response.

The Advisory Committee did not vote on whether Essure should continue to be available last September. The Committee members spent more than four hours discussing ways to minimize women’s risks; considering changes to the product label; debating whether additional data were needed on Essure’s safety and/or efficacy; and considering Essure’s overall risks and benefits in specific populations.

At the end of the 12-hour meeting, Essure remained on the market, much to the dismay of many of the E-sisters, who had traveled long distances at their own cost to speak out against the device. The Committee did express a desire for additional post-market data, especially on metal/nickel sensitivity; recommended several modifications to the patient labeling; and recommended the creation of a registry to follow patients, which the Network had advocated for both in 2002 and 2015. On February 29, the FDA released an official announcement about its plans to improve patient and clinician knowledge of Essure's safety.

Since the FDA meeting, the E-sisters have continued to raise awareness about the harms they experienced after receiving Essure. Most recently, they have taken their fight to the halls of Congress. On November 4, 2015 — the 13th anniversary of Essure’s approval — the E-sisters joined Representative Michael Fitzpatrick (R-PA), as he introduced the bipartisan E-Free Act. The legislation would rescind Essure’s approval, thereby removing it from the market.

The NWHN supports women advocating for the health care they need and will continue to press the FDA to ensure women have access to sufficient information to make fully informed decisions about Essure. We will also continue to exert pressure on the FDA to follow through on the Advisory Committee recommendations.

When women speak, NWHN listens – and so should the FDA.

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Resources

References

1. Mao J, Pfeifer S, Schlegel S, et. al., “Safety and efficacy of hysteroscopic sterilization compared with laparoscopic sterilization: an observational cohort study,” BMJ 2015; 351 doi: http://dx.doi.org/10.1136/bmj.h5162

2. Berkrot B, “CORRECTED: Higher risk of surgery seen with Bayer Essure contraceptive study,” Reuters Technology, October 14, 2015. Available online at: http://www.reuters.com/article/bayer-contraceptive-surgery-idUSL1N12D1HF20151014.