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October 7, 2015

Takeaways from the FDA Public Hearing on Bayer’s Essure® Device

by: Fidelma L. Fitzpatrick

On Sept. 24, 2015, an FDA Advisory Committee met to discuss the risks and benefits of Bayer’s Essure® permanent birth control device. Afterward, a colleague of mine who was present for the discussion relayed many of the heartbreaking stories bravely shared by women with Essure implants, as well as the commentary and insights of the Panel members. 

Essure, made and sold by Bayer Healthcare, is designed to be inserted into the fallopian tubes to provide permanent female sterilization. Bayer claimed at the hearing that its Essure system, which is composed of a nickel-titanium alloy (nitinol) and polyethylene fiber, is both safe and effective for women. Bayer also claimed that Essure presents additional cost-saving benefits for women because it can be inserted in an office setting without general anesthesia.

The device’s benefits, however, do not come without risks—and for some those risks are both unexpected and far outweigh the benefits touted by Bayer.

From across the country: women speak out against Essure

Many women who had been implanted with the Essure system traveled from all over the United States to testify at the hearing about injuries they have suffered, which they allege are related to Essure. These women gave moving statements, telling of severe and debilitating chronic pain, loss of hair and teeth, unexplained weight gain, excessive and uncontrolled bleeding, migration of the device into other organs, painful sexual intercourse and removal surgeries that included hysterectomy and salpingectomy, or removal of the fallopian tubes. 

Each speaker also shared how these symptoms had impacted their lives and families, and many testified as to how their injuries prevented them from so many of life’s joys such as caring for their children and being intimate with their partners, as well as their difficulties with permanent disability, job loss and financial distress. To make matters worse, several of the women also stated that the doctors who implanted their Essure system did not know what to make of their symptoms and that finding a doctor to help them or to remove the Essure system was difficult and sometimes took years to find.

One woman who was a participant in the clinical trial for Essure showed her medical records to the committee, which appeared to have been changed to remove her complaints of pain and discomfort during the trial. The FDA stated that it attempted to obtain the original clinical trial records from Bayer to further investigate this claim, but was told by Bayer that the records had been destroyed. The pre-market clinical trials lasted from July 1998 to June 2000.

FDA raises concerns about Essure testing

Following the women’s testimonies, the FDA pointed to the recent spike in adverse event reports, with more than 80 percent of the 5000-plus reports being made in the past two years and some of them including painful issues such as migration of the device, device breakage, pain and menstrual irregularities, among others. The FDA also asked questions of the Advisory Panel, the answers to which will help the FDA formulate a plan of action for the Essure device moving forward. 

After allowing time for Bayer, the FDA, and members of the public to speak, the Advisory Committee asked questions to everyone who testified. Many of the questions centered on the nickel-titanium alloy in the Essure device. Bayer has included “[k]nown hypersensitivity to nickel confirmed by skin test” as a contraindication for the Essure device since 2002, but when asked by committee members, Bayer was unable to provide any data on whether such a skin test was performed on any of the original clinical trial participants, or whether a skin test is a reliable or accurate way to detect if Essure recipients will have an allergic reaction to the device. 

Additional concerns were raised about the lack of reliable and accurate data regarding the Essure device, including the failure of Bayer or its predecessor to complete any randomized clinical trials—considered by the FDA to be the “gold standard” of medical and scientific research.

Many members of the Advisory Panel also stated that if physicians did not have access to facilities or fellow providers capable of removing the Essure device, they should not be implanting it in women. 

No clear answer from the FDA 

When asked about potential regulatory actions that may be taken by the FDA, many Panel members believed that it was too late to order a randomized control trial to obtain more accurate safety and efficacy data on the Essure device. They believed that bad publicity regarding Essure’s safety profile has likely prohibited the ability to find women willing to participate in clinical trials. 

The Advisory Panel did, however, reference past actions of the FDA as a possible guide for action on Essure, including its ordering of post-market studies of certain transvaginal mesh devices, which were issued in the FDA’s January 2012 order. The cases against transvaginal mesh manufacturers continue to wend their way through the court system, and our firm continues to represent and advocate for women suffering from these allegedly defective devices.

At the conclusion of the meeting, the FDA thanked all the attendees, including the public citizens who spoke, noting it is not easy to present such personal information about their lives and health to a room full of strangers. 

A full recording of the meeting is available on the FDA’s 2015 Meeting Materials of the Obstetrics and Gynecology Devices Panel webpage. The FDA will spend the next weeks to months evaluating the information presented at the meeting as well as any possible regulatory action. 

I’ll continue to follow any major updates regarding Essure and actions the FDA takes and relay them.