WASHINGTON — The Food and Drug Administration said Monday that it is restricting the sale and distribution of Essure, a contraceptive device that some patient advocates want taken off the market.
Only health care providers and facilities that guarantee women have been told about the device’s risks in advance will be allowed to implant it.
Using what it called “a unique type of restriction,” the FDA said providers must first review a brochure with patients that lists Essure’s risks. The patient then must be given the opportunity to sign the document, and the physician implanting the device will be required to sign it.
The agency said Bayer, which manufactures the device, will be responsible for implementing the restrictions immediately and for ensuring that providers comply.
The agency said it will take appropriate action against Bayer, including imposing criminal and civil penalties, if the company does not follow through.
FDA Commissioner Scott Gottlieb said in a statement that the agency was making the checklist mandatory because some women were not being adequately informed of Essure’s risks, “despite previous efforts to alert women to the potential complications ... . That is simply unacceptable. Every single woman receiving this device should fully understand the associated risks.”
Essure is a permanent birth-control device. In a procedure that takes about 10 minutes, doctors insert two sets of tiny coils through the vagina and cervix and into a woman’s fallopian tubes, which carry eggs from the ovaries to the uterus.
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Over a period of about three months, scar tissue is supposed to form around the inserts, creating a barrier that keeps sperm from reaching the eggs.
Bayer is facing a raft of lawsuits from patients who say they have experienced complications related to the product, including perforation of the uterus or fallopian tubes, persistent pain and allergic reactions. Some women also have reported headache, fatigue, weight loss and depression, but whether those symptoms are linked to Essure “is unknown,” the FDA said Monday.