SAN DIEGO - Bayer Healthcare is changing its patient information booklet on its product Essure birth control to include the two most common side effects from women – pelvic pain and device migration of the two metal coils used in the procedure.
Unlike a traditional tubal ligation, Essure is marketed as permanent birth control without surgery. It's marketed as cheaper, easier and safer than a woman getting her 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.
Some other common complaints include bloating and rashes. Women also reported serious issues like miscarriages and the metal coils migrating out of their fallopian tubes.
Last month and just discovered by Team 10, the pharmaceutical company requested that the Food and Drug Administration allow them to change their patient information booklet to include the two most common side effects.
The booklets now will include "additional information on risks of chronic pelvic pain and device migration" in the information provided to patients.
Bayer told Team 10 partners, the ABC 15 Investigators in Phoenix, it continuously reviews 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 requested changes just a few weeks later. The FDA told Team 10's partners in Phoenix 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.
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.
Thousands of women like them have taken to social media, where thousands of women are sharing their experiences. The posts are from thousands of women who say they have the exact same symptoms. They tell nightmare scenarios after getting the Essure coils implanted.
Most of the comments and photos detail side effects from an allergy to nickel, which is a component of the coils. Originally, women were advised to test for that allergy before getting Essure, but the manufacturer asked the FDA to remove that requirement a few years ago.
Activist Erin Brokovich has taken an interest in the complaints and has launched her own petition.
Rally near Washington, D.C.
Last 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. Rally participants said 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.