FDA wants new studies, label alert for Essure

The Food and Drug Administration said Monday that it will require German drugmaker Bayer AG to undertake new safety studies on its permanent birthcontrol device Essure, after thousands of women complained about complications from the controversial implant. The agency also recommended a “black box” label warning about the device’s potentially serious side effects, plus a risks checklist for doctors to discuss with patients.

The agency’s decision Monday drew immediate criticism from a community of women who have said the device caused devastating health problems — including pelvic pain, stomach swelling, dizziness, cramping, bleeding and fatigue. They have waged a persistent social media campaign to have Essure pulled from the market.

Bayer has maintained that Essure, which the FDA approved in 2002, has a solid safety record and should remain available as an option to women seeking permanent birth control.

The FDA held a much-anticipated public meeting on Essure last fall amid growing reports of complications. The women who spoke detailed harms they attributed to the device, including unplanned pregnancies when it failed and surgeries to remove it after painful side effects.

Bayer, which is facing several lawsuits over Essure, has insisted the device is 99 percent effective when inserted properly and when women use birth control until a follow-up visit several months after the procedure. The company says about 1 million of the devices have been sold.