FDA Responds to Citizens' Petition to Remove Essure Birth Control from MarketMar 30, 2015
The Food and Drug Administration (FDA) responded last week to a petition signed by more than 2,100 women who want the agency to take Essure permanent birth control off the market.
The agency closed the petition, and forwarded it to the Office of Compliance, which will investigate the serious claims made against the device and "pursue actions as deemed necessary," the FDA said in its response, ABC15 (Arizona) reports.
The citizens' petition was submitted in January by a Florida law firm. The group collecting signatures had the assistance of famed consumer activist Erin Brockovich. Her organization received appeals for help from women who blame Essure for injuries they suffered. Brockovich's web site reports instances of chronic pain, colon perforations caused by movement of the device, implants that have been lost and are no longer visible on scans, pregnancies despite the presence of the Essure device, and debilitating headaches.
Essure is a permanent form of birth control. Flexible metal coils are implanted in the fallopian tubes; scar tissue forms around them, preventing fertilization. The procedure is done on an outpatient basis and takes about 10 minutes to perform, according to Bayer HealthCare Pharmaceuticals' online materials.
The petition claims the original manufacturer of the device, Conceptus, Inc., perpetrated fraud during the clinical trials and violated the terms of the FDA's premarket approval of the device, ABC15 reports. The company is also accused with violating federal laws in the manufacturing and marketing of Essure. Bayer HealthCare bought Conceptus in 2013.
Essure was given premarket approval by the FDA in 2002 and this approval would normally shield the manufacturer from product liability claims. But lawsuits filed by women who claim injuries from Essure allege the manufacturer broke the conditions for that approval making the Conditional Premarket Approval "invalid" and the product "adulterated" under FDA definition. The citizens' petition also makes this claim and the petitioners request that the FDA take a number of actions against Bayer HealthCare Pharmaceuticals, including directing a recall of the device, according to ABC15. They are asking them to immediately withdraw its approval of Essure birth control and initiate a recall.
Doctors and patients have filed more than 4,500 adverse event reports with the FDA, describing side effects and injuries they allege were caused by Essure. The reports include deaths of women implanted with the device and premature births in women who became pregnant while implanted with Essure, according to ABC15.
In a statement, Bayer said it "stands behind the safety and efficacy of Essure" and the company will respond "to any questions that [the FDA] may have related to the petition." The company said it would "aggressively defend itself in Court" in the product liability lawsuits, according to ABC15.