Bayer Must Study Side Effects of Permanent Birth Controlby
Adverse events include pelvic pain and uterus perforation
FDA recommends a boxed warning for sterilization devices
Bayer AG must do a study of its permanent birth control device Essure while it’s on the market to help better understand the potential risks to users, the Food and Drug Administration said Monday.
“While the FDA believes Essure remains an appropriate option for the majority of women seeking a permanent form of birth control, some women may be at risk for serious complications,” the FDA said in a statement.
Regulators received more than 5,000 complaints about Essure, most of them since 2013, from women who experienced pelvic pain, cramping and perforation of the uterus after the device moved. The FDA wants to better determine the causes of pain and other severe side effects that some women have complained about. Essure was approved in the U.S. in 2002.
“Bayer will continue to closely work with the FDA to address their latest recommendations and to ensure the safe and effective use of Essure,” the company said in an e-mailed statement.
The FDA also recommended that sterilization devices carry a boxed warning, a label reserved for products that could cause death or serious injury, explaining the possible side effects. The recommendation is part of a draft guidance on such devices that the agency will finalize after seeking comments from the public and the industry for 60 days.
Essure works by creating a barrier to the fallopian tubes so sperm can’t reach the eggs. A doctor inserts the device through the vagina into the fallopian tubes, where it produces an immune response and tissue builds up around it, blocking the tubes.