FDA Threatens Bayer With Penalties Over Contraceptive DeviceBy
Essure device already has strict safety warning on label
Bayer must improve doctor discussions with patients, FDA says
The U.S. Food and Drug Administration is threatening Bayer AG with civil and criminal penalties if it doesn’t better inform women about risks from one of the company’s contraceptive devices.
Bayer’s device, Essure, is a permanent contraceptive developed by the German drugmaker as an alternative to surgical techniques like tying or severing the fallopian tubes. U.S. regulators found that some doctors weren’t always telling women about the Bayer’s device’s risks, which can include bleeding, pain and organ perforation.
The move by the FDA signals the agency’s increasing oversight of health products already on the market.
“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,” FDA Commissioner Scott Gottlieb said in a statement. “Every single woman receiving this device should fully understand the associated risks.”
After noticing an increase in side effects, the FDA added new warnings for Essure in 2016, including a checklist that doctors were supposed to go through with patients. Under the new restrictions, only doctors and health facilities that discuss those risks with all patients will be legally allowed to implant Essure, the FDA said. The FDA threatened to impose civil or criminal penalties if Bayer doesn’t make sure patients are informed.
In a statement, Bayer said it has worked with doctors to make sure that patients understand the product before it is implanted. The company said the FDA has repeatedly found the device to be safe and effective.
Under Gottlieb, the health agency has been aggressive about expanding its reach, and the restrictions on Essure are the first time the FDA has threatened such penalties using its authority to regulate medical devices after they’re on the market. Last year, the FDA asked Endo International Plc to pull its powerful opioid painkiller Opana ER from the market based on what it called public-health risks.
Essure already has what’s known as a black-box warning, the agency’s strongest. The FDA sometimes orders companies to study their drugs or devices after they are approved, though firms don’t always comply.
Bayer’s device, which is an alternative to sterilization surgeries, was first approved in 2002 and is the only product of its kind on the market. Sales of the device have declined sharply since the warnings were added, and Bayer stopped selling the device outside the U.S. last year.
About 16,000 women have sued Bayer over alleged harm they suffered because of the device. Bayer won a victory earlier this month in California, where many of the cases have been consolidated, after a judge threw out many of the claims. The California case now focuses on whether Bayer adequately reported adverse events to the FDA.
There were no new safety guidelines or additional risks associated with the product added as a part of the FDA’s action.