Since it was approved to go on the market in 2002, Essure, an implantable permanent contraceptive device, has been plagued by controversy. Thousands of women have filed grievances with the US Food and Drug Administration about unintended pregnancies, miscarriages, stillbirths, severe pain and bleeding.
In its latest response to ongoing concerns, the FDA issued an order Monday to restrict sales and distribution of the device.
The only implantable permanent women's contraceptive, Essure, faces new restrictions
The FDA is responding to complaints from women about the device
"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 written statement.
"Despite previous efforts to alert women to the potential complications of Essure," he continued, "we know that some patients still aren't receiving this important information. That is simply unacceptable."
Essure is the only non-surgical permanent form of birth control for women on the market in the US. A health care provider inserts the flexible coils of the device into the fallopian tubes by going through a woman's vagina and cervix. When it works as intended, scar tissue forms around the device over the course of about three months and builds a barrier to block sperm from reaching -- and fertilizing -- a woman's eggs.
Between November 2002 and May 2015, more than 5,000 complaints about the device were registered, prompting the FDA to order manufacturer Bayer to complete a post-market study, including effectiveness and adverse events. The agency also required Bayer to add a black box warning label to the product, to call attention to the risks. Sales of Essure fell in the US by about 70%, the FDA reports.
Bayer said in a statement Monday that "The benefit/risk profile of Essure has not changed and remains positive."
But, the pharmaceutical company added, "Patients deserve the most accurate and comprehensive information to help make their healthcare decisions, and Bayer has educated and continues to educate healthcare providers about the importance of appropriately counseling each patient on the benefits and risks of Essure. The FDA requested we update the label to emphasize this point."
The company touted its commitment to "Providing women with safe and effective healthcare options that meet their individual needs."
The online support group Essure Problems, which has more than 36,000 members, said in a statement Monday that it reported to the FDA commissioner that 95% of women implanted with the device after the FDA's previous guidance still weren't getting warnings about Essure.
Last year, nearly 12,000 "adverse event reports" were submitted, including stories of device removals that required hysterectomies, said Madris Tomes, founder and CEO of Device Events, which seeks to bolster patient safety by sharing information about negative reactions to medical devices.
The FDA outlined in its Monday release how some patients experienced "perforation of the uterus and/or fallopian tubes, migration of inserts to the abdominal or pelvic cavity, persistent pain" and more.
Bayer mentioned in a recent financial report that as of January 30, more than 16,000 Essure users had filed lawsuits against the company, alleging outcomes that included hysterectomies, perforations, depression and weight gain.
The new legally required labeling on Essure will permit the sale and distribution of the cotraceptive device only to facilities and health care providers that review, complete and sign with patients a brochure entitled a "Patient-Doctor Discussion Checklist -- Acceptance of Risk and Informed Decision Acknowledgement."
It is on Bayer to implement these restrictions, the FDA reports. Failure to comply will result in FDA action "including applicable criminal and civil penalties."
It was welcome news to the Essure Problems community, though its members still would prefer that the device be taken off the market.
"While it doesn't take Essure off the shelves, it certainly holds Bayer accountable," the group said in its statement.