Women harmed by sterilization coils push FDA to act

STERILIZ05aanws
Essure is a tiny coil that is inserted in a woman’s fallopian tube to create scarring that blocks it.

The ranks of women harmed by Essure sterilization coils continue to grow, while the U.S. Food and Drug Administration’s efforts to inform them of the risks are not working, a 37,000-member advocacy group declared Tuesday.

Administrators of the six-year-old Facebook group Essure Problems said that in the first quarter of this year, the FDA received about 2,000 reports of women who underwent operations — usually hysterectomies — to remove coils that were causing complications such as pain and bleeding.

More than 9,000 removals have been reported since 2009, in addition to miscarriages, fetal deaths, and other problems, according to an analysis of the FDA’s “adverse events” reporting system. It was conducted by Madris Tomes, a former FDA manager who is the founding CEO of Device Events, based in York, Pa.

Angie Marie Firmalino, 44, a co-founder of the Essure Problem group on Facebook

“More than 15,500 adverse-event reports have been filed,” said Essure Problems cofounder Angie Marie Firmalino, 44, of Tannersville, N.Y., who needed a hysterectomy to get rid of fragments of broken coils. “We feel like the FDA needs to step in and take action. How much harm is acceptable for a non-lifesaving device?”

Asked for comment, the FDA said it “continues to review the available information about Essure, including reports of problems submitted to the FDA.”

The manufacturer, Bayer Healthcare, emailed: “We take all adverse events seriously. … We have reached out to many women who have reported complications … and provided any guidance we can. There are risks with all medical procedures.”

Surgeries to Remove Essure

This analysis of data from the FDA’s voluntary adverse events reporting system shows how many women needed surgery — either hysterectomy or fallopian tube removal — to remove the Essure sterilization coils because of severe problems such as pain and bleeding. Reports have been steadily increasing with growing awareness of the dangers.
Staff Graphic

Essure Problems has been among those pushing the FDA since 2013 to take Essure off the market. The coils, approved 15 years ago, are implanted in the fallopian tubes to scar them shut. The device is marketed as a simple, nonsurgical alternative to conventional tubal surgery.

Last year, the FDA ordered Bayer to add label warnings that Essure can cause chronic pain, organ perforation, and allergic reactions, and to create a “patient decision checklist.”

But about 200 women have contacted Essure Problems over the last six months to say that doctors did not tell them about the label warnings or use the three-page checklist.

“Unfortunately for many women, they are being implanted without informed consent,” administrators of the Facebook group emailed the FDA on Monday, demanding tougher action.

The FDA’s response, shared by the group: “We understand your frustration. We assure you, Essure is a high-priority issue for the Agency and we continue to take feedback like yours into consideration.”

Bayer, which acquired Essure in 2013, has been hit by thousands of lawsuits over the coils. Last year, the German-based company’s annual report said it incurred losses of $413 million in connection with the devices.

Bayer has said it does not know how many women have implants, just that about a million Essure “kits” had been sold worldwide, most in the U.S. The company recently announced it would discontinue sales in two small markets, Finland and the Netherlands.

Continue Reading