FDA issues Black Box Warning for Bayer’s birth control implant Essure
March 01, 2016 11:44 AM EST
The Food and Drug Administration (FDA) announced Monday that German pharmaceutical company Bayer AG must add a "black box warning" label on their permanent birth control implant, Essure.
The label, which is the strongest level that the federal agency can issue, must include all of the potential risks involved with using Essure as well as a checklist that doctors must discuss with their patients.
The FDA will also be recommending Bayer AG to conduct a new post-market study to examine the safety of using Essure, which has been on the market since 2002, in comparison to tubal ligation. The study will include more than 2,000 women, who will be followed for a minimum of three years.
"The agency has carefully reviewed all the available evidence ... While there are risks associated with the use of Essure, there are also benefits," William Maisel, chief scientist at FDA's Center for Devices and Radiological Health, said reported by the Washington Post. "We believe informed women should have this as an option available to them."
Essure is a small and flexible coil that gets inserted into the Fallopian tubes. Over the course of about three months, tissue should form around each coil, which would then block the tubes and stop pregnancies permanently.
The FDA's decision to keep Essure on the market has been criticized by women and lawmakers.
"It's unbelievable that it took the FDA since September to make just two recommendations with no enforcement measures and [to] ask the manufacturer to perform another study while leaving Essure on the market," Rep. Mike Fitzpatrick (R-Pa.) said. "It's been done. The evidence is all there: Tens of thousands of injured women and hundreds of fetal deaths."
Fitzpatrick has been pushing the agency to stop the use of Essure until more is known about its safety.
The Facebook group, Essure Problems, added, "These studies could take several years, and leaving the device on the market will only put more women's lives at risk. We are disappointed but not surprised the FDA has once again chosen to side with industry rather than protect patients of a failed medical device."
On Essure Problems' page, thousands of women have shared the health problems that they have endured after getting Essure. The side effects have ranged from chronic pain and bleeding to autoimmune disorders. The problems appear to arise when the coils break off or move around.
From November 2002 to May 2015, more than 5,000 women have filed grievances with the federal agency in regards to Essure. Despite the complaints, Bayer has continued to state that Essure is safe to use. Bayer will be working with the FDA to enforce the two recommendations.
As per usual, the FDA will be receiving public comment for 60 days.