Recent complaints made by a significant number of women has sparked outcry about Essure, a permanent birth control product by the company Bayer and its affiliated company Conceptus. Essure is non-surgical and inserted inside a woman’s body by her OB-GYN. Complaints and lawsuits have been filed against the corporation claiming patients are developing terrible side effects consisting of severe pain which some experts believed is caused by the coils growing into the lining of the vaginal walls causing scar tissue and other complications.
Women who are suffering now have the option of having the product surgically extracted and some even have to have a partial or total hysterectomy. A group of women started a Facebook page called EssureFL and are sharing their experiences and thoughts about the product. Some women on the page have posted openly that this otherwise non-traditional kind of online dialogue has helped them throughout the process; from finding a doctor to remove the product, to words of encouragement. In a news release dated May 1, 2015 Bayer defended the product by stating, “a 5-year follow up study further supports the effectiveness and safety of the Essure ‘Procedure’ as a non-surgical, non-hormonal option for permanent contraception.” The problem with that statement, some say, is the company defends the procedure of implanting the device, which is copper coils, into the woman’s body, yet it does not explain the injuries that come thereafter in an otherwise healthy woman.
The news release also stated, “Among the 364 women relying on Essure inserts who completed the full five years of follow-up, no pregnancies were reported. In addition, the Essure inserts were generally well tolerated.” Yet, Bayer continues by stating 7% of the women in the trial suffered chronic pain thereafter. “Essure is supported by more than a decade of science and real world clinical experience,” said Edio Zampaglione, MD, Vice President, U.S. Medical Affairs, Women’s Healthcare and Neurology. “Bayer is strongly committed to providing access to a wide range of safe and effective contraceptive options for women, and we look forward to continued research on Essure.”
Bayer does admit severe injuries to patients who were enrolled in the clinical trial. One woman with irregular menstrual bleeding, another woman with lower abdominal pain and very heavy periods, and a third woman with continuous bleeding. The latter two patients ultimately had to have a hysterectomy. Even still, Bayer continued to defend the product by stating, “Essure is a safe and effective permanent birth control option for women when health care providers and patients follow the Instructions for Use. Most of the side effects that have been reported about Essure are known and included in the Instructions for Use.”