Bayer changes Essure patient booklet to include important health warnings after ABC15 Investigation

PHOENIX - BAYER CHANGES PATIENT BOOKLET

After years of struggling, women fighting to raise awareness about Essure birth control are finally being heard.

The ABC15 Investigators first told you about thousands of women voicing their concerns about problems with Essure in October. Common complaints include bloating, rashes and chronic pelvic pain. Women also reported serious issues like miscarriages and the metal coils migrating out of their fallopian tubes.

Now, the current manufacturer of the permanent birth control device, Bayer Healthcare, is making major changes.

Last month, the pharmaceutical company requested that the Food and Drug Administration allow them to change their patient information booklet to include side effects of the two most common complaints from women.

They will now include "additional information on risks of chronic pelvic pain and device migration" in the information provided to patients.

Bayer told the ABC15 Investigators they continuously review available information about their products, and "when appropriate…work collaboratively with the FDA to update the information available to patients and physicians."

PATIENTS TO BE WARNED

The FDA approved those changes just a few weeks later. The FDA told the ABC15 Investigators the approved changes were "done to include rare adverse events identified in the Essure physician labeling, but not included in the Essure Patient Brochure."

Essure is marketed as permanent birth control you can get without having surgery. It's meant to be cheaper, easier and safer than getting your tubes tied. During the procedure, two metal coils are placed inside the fallopian tubes. Over the next three months, scar tissue is supposed to amass around the coils, blocking conception.

Essure has been on the market since 2002. According to the manufacturer, about 750,000 women have had it implanted to date.

There are now more than 3,700 women sharing their health issues with Essure on the "Essure Problems" Facebook page – and the numbers keep growing.

RALLY NEAR WASHINGTON, D.C.

Sunday, about a dozen women fighting for Essure awareness rallied outside of the AAGL annual conference near Washington, D.C. The organization represents more than 7,000 gynecologic professionals worldwide.

The AAGL's Executive Board agreed to meet with the protesters to talk about their concerns about Essure. The results are promising.

The AAGL agreed to present these actions to their board for approval:

- Instruct their members to address the side effects women are experiencing with Essure

- Help women find doctors who can properly remove the Essure coils

- Conduct independent research on the device and its safety and efficacy.

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