FDA calls for ‘black box’ warning on Essure birth control device

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THE BRONX -- It wasn’t the announcement that Lisa Saenz, a Bronx social worker and mom, was looking for.

“It doesn’t look like they’re pulling Essure from the market, which is what we were hoping for,” Saenz told PIX11, after learning the Food and Drug Administration had finished its three-month review of the product that’s billed as a permanent, non-surgical, sterilization device.

The FDA announced Monday that it will require Bayer HealthCare to perform a new, post-marketing study on Essure, which has been plagued by thousands of complaints from women.

Nearly 10,000 sent their reports of negative health effects to the federal agency, before—and after—hearings were held last September in Washington, D.C.

The FDA also stated Monday that Bayer will have to post a “black box” warning label on the device, when it’s sold in doctor’s offices for implantation. This would be “designed to call attention to serious or life-threatening risks,” according to the FDA website.

Essure coils—which are inserted through a woman’s cervix and vagina and used to block the Fallopian tubes—were given FDA approval in 2002.

The device received a coveted “Pre-Market Approval” status from the federal agency, meaning the FDA was convinced the product had been put through rigorous safety testing over a five-year period of study.

It also meant women who had the Essure procedure couldn’t sue.

The Essure coils are made of nickel, and many women believe they triggered severe allergic reactions in their bodies.

They reported abdominal pain, bloating, rashes, migraine headaches, and even unwanted pregnancies.

A number of women had hysterectomies.

“The potential to get pregnant shouldn’t be so high, and in our group alone, we have over 600 ‘live’ births,” said Saenz, who runs a Facebook group called Essure Problems of New York and New Jersey.

A couple of weeks ago, a Pennsylvania congressman, Mike Fitzpatrick, lobbied the FDA to take the product off the market. He cited data showing more than 300 fetal deaths were reported, by women who got pregnant after having the Essure procedure done.

Bayer HealthCare told PIX11 at the time, the data was flawed.

“Ectopic pregnancies and blighted ovum are not considered fetal deaths,” Bayer said in a statement , “and can occur for a multitude of reasons not related to Essure.”

Bayer, which bought the Essure device from the original manufacturer—Conceptus, Inc—has been very sensitive to the criticism about a product that’s been sold to 750,000 women, according to the company.

“Choice of contraception and the decision to use a permanent method is a very personal one that should be made between a woman, her partner and her healthcare provider. Not every option is right for every woman. This is why choice is so critical. Tubal ligation and, actually, pregnancy itself, carry risks, which can be serious,” Bayer said just two weeks ago.

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