A House lawmaker wants federal regulators to pull a controversial birth control device called Essure off shelves because it is unsafe.
Rep. Rosa DeLauro, D-Conn., said the Food and Drug Administration should remove Bayer’s Essure system for permanent female sterilization since more than 5,000 safety reports have been filed by doctors and patients.
The reports include five deaths and four fetal deaths associated with the products, according to the letter.
“A citizen petition filed on behalf of hundreds of women injured by Essure asks FDA to remove the device from the market,” DeLauro wrote on Friday. “FDA should take immediate action to do so.”
Agency expert advisors met late last month on the device, which has been on the market since 2002.
The agency did not return an immediate request for comment. However, it has said that it reviewed the safety reports, noting that the most common were pain (3,353) and menstrual irregularities (1,408).
“The FDA takes reports of safety concerns seriously,” according to a June statement.
Essure differs from the once-a-day birth control pills in that it is an implant that is intended to keep sperm from reaching eggs and preventing conception, the agency said.
Bayer Healthcare did not immediately return a request for comment.
