A group of women has filed a lawsuit against Bayer HealthCare over adverse effects of the Essure birth control system.
Twenty-eight women filed the lawsuit together on March 21, 2017. Each woman alleges she suffered adverse health effects as a result of having Essure implanted.
This lawsuit originally appeared in the Superior Court of Alameda County (California), but the defendants say that because this case has a federal jurisdiction question it should be tried in federal court instead.
The plaintiffs claim that Bayer did not warn them of serious health risks that were revealed after Essure began to be sold in the United States. Anvisa (Agencia Nacional da Vigilancia Sanitaria), Brazil’s health regulatory agency, recently suspended the importation, distribution, marketing use and dissemination of the Essure system and also recalled Essure devices that had already been distributed.
Personal injury firm Parker Waichman notes the thousands of serious Essure complications reported Essure since Essure came to market in 2002.
Essure Permanent Birth Control
Essure is the first non-surgical form of sterilization approved by the U.S. Food and Drug Administration (FDA). Before Essure came to market in 2002, permanent birth control required surgery to sever the fallopian tubes (usually referred as having the tubes “tied”).
Essure consists of two small, flexible metal coils that are inserted into the fallopian tubes. The coils cause scar tissue to form, blocking the tubes and preventing pregnancy. The insertion can be done in a brief procedure in a doctor’s office, without anesthesia or the risks or recovery time involved in surgical sterilization. A few months after Essure is implanted, the doctor is supposed to do imaging to make sure the fallopian tubes are blocked and she cannot become pregnant. Unless the tube blockage is confirmed, the woman could still become pregnant, despite Essure.
Thousands of women who have had Essure inserted report serious side effects. The women say Bayer downplayed the true safety risks of Essure, marketing the device as a safer, simpler, and more effective method of permanent birth control than other options available.
Women who have had Essure implanted say they have suffered serious Essure complications including:
- pelvic, abdominal and back pain
- device migration
- weight gain
- heavy menstrual bleeding
- irregular menstrual cycles
- metal allergy
- organ perforation
- unplanned pregnancy
- ectopic pregnancy
Some women who have become pregnant even with Essure in place have had successful pregnancies and healthy deliveries, but others have experienced complications and miscarriages. Ectopic pregnancy—where the embryo implants outside the womb—can be life threatening if not detected soon enough. If Essure migrates from its proper location and perforates an organ this can lead to infection and dangerous complications.
Some of the most serious Essure adverse effects emerged only after thousands of Essure devices had been implanted in women. The plaintiffs in the new Essure lawsuit believe that Bayer Healthcare became aware of these serious problems but failed to inform healthcare providers and, in addition, failed to report what they knew to the FDA. Plaintiffs allege that even after 16,000 Essure adverse effects complaints, Bayer still failed to warn either the medical community or women of the risks.
In September 2015, the FDA Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee met to hear expert scientific and clinical opinions about Essure. A number of women appeared before the panel to share their experiences with Essure. In October 2016, the FDA directed Bayer to add a black box warning to Essure to notify consumers and healthcare providers of the serious risks. Many women, however, felt the warning was not strong enough in light of the injuries and complications women have reported. They feel Essure should be pulled from the market.
The plaintiff group says that not only did Bayer fail to warn about health problems but also mounted an aggressive marketing campaign to promote Essure. According to the plaintiffs, the campaign was false and misleading.
Bayer claimed that Essure “eliminates the risks, discomforts and recovery time associated with surgical procedures.” Allegedly, Essure devices “stay secure, forming a protective barrier against pregnancy.” But the women say that for many women, the device did not “stay secure,” and when it migrated, it caused serious damage to other organs. Many women say they had to undergo a hysterectomy to remove Essure and repair damage.
Legal Help for Women Harmed by Essure
If you or a woman you know has experienced Essure side effects, including unintended pregnancy, the attorneys at Parker Waichman LLP can provide a free, no obligation evaluation of your legal rights. To reach the firm, fill out the contact form or call 1-800-YOURLAWYER (1-800-968-7529).