The FDA issued an order to restrict sale and distribution of the Essure device, to ensure that women considering the permanent contraception device are provided with adequate risk information to make informed decisions.
After noticing an increase in side effects, the FDA added new warnings for Essure in 2016, including a checklist that doctors were supposed to go through with patients.
New Essure labeling, which is now legally required when the product is offered to a patient, restricts the sale and distribution of the device to only health care providers and facilities that provide information to patients about the risk and benefits of Essure. The patient then must be given the opportunity to sign the document, and the physician implanting the device will be required to sign it.
At a meeting this February between FDA chief Scott Gottlieb and representatives from a Facebook group representing 36,000 current and former Essure patients, the women provided survey data from the group showing that of the 476 women who had joined since the black box warning was added, only 8 claimed their doctors had told them about the safety issues.
Bayer emphasized that the risk-benefit profile of Essure had not changed and that communicating risks with patients was in keeping with its values as the device's manufacturer.
Under Gottlieb, the health agency has been aggressive about expanding its reach, and the restrictions on Essure are the first time the FDA has threatened such penalties using its authority to regulate medical devices after they're on the market. "Every single woman receiving this device should fully understand the associated risks".
Bayer's device, Essure, is a permanent contraceptive developed by the German drugmaker as an alternative to surgical techniques like tying or severing the fallopian tubes. But the metal implant, called Essure, will remain on the market.
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.
Essure, approved by US regulators in 2002, was given the strongest safety warning label on the device in early 2016 following thousands of complaints.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices.
In the 16 years since approval, the FDA said it has received more than 26,000 reports of adverse events - nearly 12,000 last year alone - including miscarriages, fetal deaths, and other problems.
Because of the reported complaints, Bayer was ordered to conduct a 2,000-patient study in 2016. The latest FDA action made such discussions mandatory. The agency noted that most of the new reports came from attorneys representing patients suing Bayer.