The medical device ‘Essure’ is an implantation method of sterilization that came to the market in 2002. The device received patient backlash from the outset and has since come under extreme scrutiny.
Over the years, women have reported serious complications from Essure and thousands have filed lawsuits against the medical device’s manufacturer, Bayer AG. Some of the complications women have reported are unintended pregnancies, tears and perforations of the uterus and other surrounding organs, as well as the sudden development of autoimmune disorders.
In summer 2018, Bayer announced the discontinuation of Essure. The company cited business reasons and stood by the safety and efficacy of the product. Sales of the device have declined significantly since April of 2018, a factor Bayer claim contributed to the decision to pull it from the market in the United States.
Essure has stood out as the only implantation method of sterilization approved by the Food and Drug Administration (FDA). But researchers estimate that nearly 10% of women who undergo the procedure could become pregnant within 10 years of implantation. This rate is nearly four times higher than traditional methods of sterilization, such as tubal ligation.
The device consists of metal coils which are inserted into a woman’s fallopian tubes to block sperm and prevent it from reaching the eggs.
It’s expected to be fully effective after three months following implantation. The procedure is done in-office, with the expectation that women return to normal daily activities the same day. Many women report mild to moderate pain or discomfort immediately following the procedure.
It is estimated, however, that nearly 10,000 of U.S. Essure patients required additional operations after their original procedure. This is due to anything from severe side-effects, the device traveling to different areas of the body, or perforations and tears requiring medical procedures.
Dr. Katy Moncivais, PhD, Medical Writer tells me: “Essure fails every test – it’s less safe, less effective, and more side effect prone than most other methods of birth control.”
Side-effects include – but are not limited to – pain with sex, back pain, abdominal pain, severe menstrual cramps, and severe pelvic pain. There have also been many reported cases of unintended pregnancies while the device was implanted. Some women carried the child healthily to term, but many experienced ectopic pregnancies, stillbirths, or miscarriages.
In the years since the device came to market, the FDA stepped in several times to regulate the product. The first steps to regulating were to enforce label changes on the device and to include a boxed warning to advise physicians and patients of the potential dangers. After these regulations were enforced, sales began to decline.
The United States was the last country to stop selling Essure to the public. Other parts of the world, including Canada, Europe and the United Kingdom, either chose to discontinue the device themselves or had it pulled from their markets by Bayer.
Activism has been central in the story of Essure.
Thousands of affected women are part of a Facebook group called Essure Problems. Last year, Netflix released The Bleeding Edge, a documentary on the medical device industry which features a section on Essure’s risk to women. A week after the documentary’s release, Bayer announced their voluntary discontinuation of the device.
Women’s health and bodies must not be compromised in the name of innovation, business or profit.
Essure was marketed as an easy method of sterilization for women who no longer wish to get pregnant. But from perforations in organs, development of autoimmune disorders, and unintended pregnancies, it has proven to be dangerous, or even life-changing, for far too many.