UPDATED: FDA slaps Bayer's birth control implant Essure with black box warning

Essure--Screenshot courtesy of Bayer

The FDA has been thinking for a while about increasing its oversight of Bayer's controversial birth control implant, Essure, and now that time has come. Regulators are slapping the device with a black box warning, a couple of weeks after an outside analyst revealed a startling number of fetal deaths linked to the product.

Regulators have ordered a clinical study to look at increased risks of Essure in certain women and issued a draft guidance with updated labeling recommendations including a black box warning label, Reuters reports. The agency also put out a checklist for doctors to use with patients to discuss the potential risks of permanent birth control implants.

Bayer is standing by its device. Essure "is an important permanent birth control option with a positive benefit-risk profile" and the company "will continue to work with the FDA to implement measures to support the continued safe, effective and appropriate use" of its product, Bayer said in a statement.

"Patient safety and appropriate use of Essure are our greatest priorities," Bayer's Senior VP and head of medical affairs for the Americas Dario Mirski said in a statement. "A woman's decision to choose a birth control method is a very important and personal one, and Bayer is committed to providing physicians with resources, tools and information to help them counsel women about Essure."

Earlier this month, Madris Tomes, founder and chief executive of data analysis firm Device Events, said that she found 303 fetal deaths linked to Essure after searching side-effect reports on the FDA's website. The agency previously said that it uncovered at least 5 fetal deaths in women who used the implant, which comprises two metal coils that are inserted into the fallopian tubes.

But Tomes' findings are just the tip of the iceberg when it comes to Essure's safety. Regulators have received thousands of complaints about the device since it was approved in November 2002. And most of those complaints come from after Bayer inherited Essure through its $1.1 billion deal for Conceptus in 2013.

The complaints didn't fall on deaf ears. In 2014, the FDA said that it would investigate Essure amid growing pushback. In September 2015, the agency held an advisory meeting where dozens of women urged regulators to withdraw the device, saying that too little is known about Essure's potential risks. About 750,000 women have used the product, and 70% of them are in the U.S.

Lawmakers are also weighing in on the issue. In October, Rep. Mike Fitzpatrick (R-PA) introduced a bill to ban Essure. Earlier this month, Fitzpatrick sent the FDA a copy of Tomes' report, asking the agency to look at the "immense discrepancy" between its numbers and the ones laid out by the analyst.

- read the Reuters story
- here's Bayer's statement

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Editor's note: This article was updated with a statement from Bayer.