April 9 (UPI) — The Food and Drug Administration on Monday restricted the sale and distribution of Essure, the only permanently implanted birth control device for women on the market that doesn’t require a surgical incision.
The federal agency announced it decided to immediately make changes after learning that some women were not being adequately informed of Essure’s risks before getting the device implanted — despite significant efforts to educate patients and doctors.
In February 2016, the FDA ordered Bayer to add a warning and patient decision checklist to the product’s labeling. Since then, sales have declined approximately 70 percent decline in the United States. The FDA originally approved the product in 2002.
“We’ve been closely evaluating new information on the use of Essure, and based on our review of a growing body of evidence, we believe this product requires additional, meaningful safeguards to ensure women are able to make informed decisions about risk when considering this option,” FDA Commissioner Dr. Scott Gottlieb said in a statement. “We take the concerns of all women affected by Essure very seriously.
“I’ve personally had the opportunity to meet with several women and hear their important concerns about this product. Despite previous efforts to alert women to the potential complications of Essure, we know that some patients still aren’t receiving this important information. That is simply unacceptable. Every single woman receiving this device should fully understand the associated risks.”
With the change, the device can only be made available by healthcare providers and facilities that provide information to patients about the risks and benefits of this device. A patient brochure, titled “Patient-Doctor Discussion Checklist — Acceptance of Risk and Informed Decision Acknowledgement,” must be reviewed with the prospective patient. The patient and physician implanting the device must sign the the acknowledgment.
The FDA said it will review and monitor Bayer’s plan to ensure the company complies with the changes. If these procedures are not followed, the FDA said it will take criminal and civil penalties action.
In a statement, Bayer said it “will continue to reinforce the use of the checklist with healthcare providers and will inform them about this important label update.”
In the procedure, a health care provider inserts flexible coils through the vagina and cervix and into the fallopian tubes, which carry eggs from the ovaries to the uterus. Tissue forms around the inserts over about three months, serving as a barrier that keeps sperm from reaching an egg.
Women have reported adverse events after implantation that include perforation of the uterus and/or fallopian tubes, migration of inserts to the abdominal or pelvic cavity, persistent pain and suspected allergic or hypersensitivity reactions. Women have also reported experiencing headache, fatigue, weight changes, hair loss and mood changes, such as depression.
The FDA said it hasn’t determined whether these conditions are related to Essure.
In a financial statement on Jan. 30, Bayer said it had been served U.S. lawsuits from approximately 16,100 users of Essure. Plaintiffs allege personal injuries from the use of Essure, and are seeking seeking compensatory and punitive damages.
But in the statement Monday, Bayer noted the FDA “has repeatedly determined — after a rigorous review of the scientific evidence — Essure … is a safe and effective medical device that benefits women by providing them with a valuable contraception option.”
In January, a study from France showed the implants are relatively safe and do not raise the risk of side effects or health problems. Researchers analyzed data from more than 105,000 French women who received sterilization between 2010 and 2014, including one-third receiving the Essure. Women who got the Essure implant faced lower immediate risk for complications than traditional laparoscopic surgery.
“While some women may continue to choose Essure as their birth control option based on current information, as new information becomes available, the FDA will continue to keep the public informed of the agency’s evaluation and findings, and consider regulatory options that appropriately balance benefits and risks for Essure,” said Dr. Terri Cornelison, assistant director for the health of women in the FDA’s Center for Devices and Radiological Health.