Safety Concerns Prompt FDA to Re-Evaluate Safety of Essure

Following patient complaints, the U.S. Food and Drug Administration (FDA) is taking action to re-assess the safety of Bayer’s Essure, a permanent female sterilization device. According to National Public Radio (NPR), the FDA’s Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee will hold a public advisory meeting on September 24, 2015 from 8:00 a.m. to 6:00 p.m. at the FDA’s White Oak Campus in Silver Spring, Maryland. The purpose of the meeting is to hear public comments from women implanted with Essure, expert opinions on the risks and benefits and recently available safety data. NPR reports that the FDA has also updated Essure’s short-and long-term risks and adverse events reported through May on its website.

The FDA approved Essure in 2002. When the soft metal spring is implanted in each fallopian tube, it induces scar tissue to form and blocks eggs from being fertilized or traveling to the uterus. The device is approved for women between the ages of 21 and 45.

The panel will discuss injuries related to Essure, including perforation and migration, device removal, chronic pain, allergic reactions, and unintended pregnancy. NPR interviewed Amanda Dykeman, who reported suffering from a number of symptoms after being implanted with Essure, including chronic fatigue; migraines; joint pain; digestive issues; back pain; heavy, clot-filled periods; difficulty concentrating; abdominal pain; hair loss; tooth deterioration; depression; and severe bloating.

The exact agenda is uncertain, but the committee may consider whether Bayer will have to make changes to Essure’s label or need to conduct more studies, said FDA spokesman Eric Pahon. “I’m anxious to attend the hearing and demonstrate everything we’ve learned about Essure and its safety and efficacy over the years,” Dykeman said to NPR. “If the right people are in attendance and they really listen to what we have to say, I believe they will have no choice but to take some kind of disciplinary action.”

In January, the FDA received a citizen’s petition calling for Essure to be taken off the market. The petition asserted that clinical trials used to gain approval for the device were flawed. The agency responded that it was reviewing the petition in April.

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