On Monday, the Food and Drug Administration announced it would take added steps to protect women from a controversial birth control implant known as Essure. From now on, women will only be able to obtain the permanent implant after their doctor sits down with them to discuss its risks and they sign a document saying they understand those hazards.
The Essure implant, manufactured by Bayer, first debuted on the market in 2002. The implant consists of two coils—one wrapping the other—that are made of nickel and various metals. During the procedure, one insert is placed into each fallopian tube via the vagina. The coils irritate the surrounding tissue, causing scarring that’s intended to prevent sperm from reaching the egg. Unlike many other contraceptives, the implant is meant to be permanent.
Though the implant is about 90 percent effective, thousands of women have reported dangerous complications from using it. Even under normal conditions, it’s been known to puncture the uterus and fallopian tubes. But the implant can also escape into other parts of the body, such as the abdominal or pelvic cavity, causing pain and triggering allergic reactions. These side effects can become so serious that women have been forced to have their implants surgically removed.
Users have also reported other symptoms, including headache, fatigue, weight changes, hair loss, and mood changes, though it’s unclear how related these symptoms are to the implant.
Thousands of former Essure users have sued Bayer as a result, though no cases have reached their conclusion as of yet. And the FDA has received more than 25,000 adverse event reports since its debut, including 12,000 in 2017 (though some reports might be duplicates). The number of injuries might be higher still—an independent report found that at least 303 fetal deaths might have been caused by failed implants as of 2016.
Some users have asked the FDA and Congress to have the product pulled altogether. In 2016, the FDA instead took a more lenient tack. It attached a black box label—the strictest warning possible—to the product, detailing the associated risks. It also told Bayer to begin conducting its own post-market studies, which are still underway.
But though sales of Essure in the US have dropped by 70 percent since the black box warning was added, according to the FDA, many former users have continued to complain that the warning wasn’t enough, prompting the FDA’s latest move.
“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 in a statement. “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.”
The FDA’s order specifically restricts how the implant can be sold and distributed. Bayer will be forced to include a label that notes the implant can be only sold by medical facilities and health care providers that pledge to discuss the product’s risks beforehand with their patients. Patients will have to go over a brochure and risk checklist with their doctor, and both patient and doctor will have to sign an acknowledgement that they read it through before the implantation procedure. The FDA will also try to track whether Bayer is actually following through with its order—and a failure to do so might prompt criminal and civil penalties.
The new restrictions mirror those taken with the acne drug isotretinoin, known by the brand name Accutane, which also has a black box warning. Before doctors can prescribe Accutane, they, along with prescribers and patients, have to enroll in a similar warning program. The program came about after it became apparent that Accutane can cause serious birth defects when taken by expectant mothers.
Bayer, for its part, has long insisted that the benefits of Essure continue to outweigh any of its risks, though it isn’t protesting the label update.
“As the FDA has repeatedly determined—after a rigorous review of the scientific evidence—Essure, the only non-incisional option available for those who seek permanent birth control, is a safe and effective medical device that benefits women by providing them with a valuable contraception option,” it said in a statement.
According to Bayer, over 750,000 women have received Essure since 2002. Last year, the EU suspended Bayer’s license for Essure, and Bayer has since stopped selling the product there.