Investigator | New warnings for birth control device

It appears that complaints from thousands of women from here and around the country about a controversial and permanent form of birth control are being heard.

The Investigator Tom Meyer recently reported on severe medical reactions that a number of women have had to the device known as Essure.

One of them was Kim Hudak, of Lakewood, who participated in the clinical trials held through the Cleveland Clinic for Essure. This birth control device consists of metal coils that are inserted into the Fallopian tubes to block conception.

But thousands of women have complained about all kinds of serious complications –- some of them, like Hudak, have had to have hysterectomies.

Now, Bayer –- the manufacturer of Essure -– is adding more warnings to accompany the product.

"I think it's a start," says Hudak. "I'm glad they're acknowledging problems they didn't acknowledge before."

But, she adds, the warnings should have been included years ago.

"They knew about these problems, they knew about them as far back as the clinical trials," says Hudak. "I had it documented in my medical records that they were not only possible problems, but absolute problems, because they happened."

Hudak shared the problems with the doctor in charge of the study, the Cleveland Clinic's Linda Bradley, but says she received no response to her emails.

The Clinic does require that its doctors list the companies with whom they have "industry relationships," and the online form for Bradley, who is an obstetrician/gynecologist, indicates that Bayer is one of the companies from which she has received at least $5,000 in fees.

Last year, Bayer acquired the company – Conceptus – that developed and manufactured Essure. Bayer confirmed the new warnings will include information on pelvic pain and migration of the metal coils – two of the most common complaints.

These complaints and complications are detailed on a special Facebook page that Hudak says has grown to include more than 5,000 women.

"The bulk of the members of this group are people who have had organs damaged from migrations, perforations -- severe issues with bowels and bladders," says Hudak.

She adds that the new warnings are a step in the right direction, but provide little clue to the severity of how Hudak and other women have suffered.

"This isn't cramps," Hudak explains. "This isn't a general discomfort. This isn't a fleeting discomfort. This is a pain that keeps some women in bed."

Since Hudak's hysterectomy, all the symptoms that started with the implant have disappeared, she says.

Bayer says 750,000 women rely on Essure. It is FDA approved, and the company says it has a well-documented benefit-risk profile.

If you want to share your Essure story on Facebook,here is the link.


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