On September 24, the Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee of the Food and Drug Administration (FDA) will meet to discuss the risks and benefits of Bayer HealthCare’s Essure birth control system.
Medical experts take a closer look at problems reported with the birth control implant Essure, including chronic pain, bleeding, headaches, and allergic reactions, US News reports.
Essure was granted FDA approval in November 2002 and is the only permanent birth control method that does not require surgery. Bayer HealthCare Pharmaceuticals’ online materials say the implant procedure can be done in a doctor’s office and takes about 10 minutes to perform. The procedure does not require hospitalization, incisions, or the recovery time of surgical sterilization.
The FDA has received more than 5,000 complaints about Essure in the 13 years it has been on the market. In April, the FDA said it would investigate Essure following complaints of fraud during the clinical trial and reports of serious side effects.
Essure consists of small, flexible nickel-titanium coils that are inserted through the vagina into the woman’s fallopian tubes. The coils cause scar tissue to form in the fallopian tubes, eventually blocking the tubes and preventing pregnancy. Once an X-ray confirms the tubes are fully blocked, the method is considered 99.83 percent effective, National Public Radio (NPR) reports.
Some studies suggest problems with Essure are relatively rare, but thousands of women have attributed health problems to the implant. Among the more serious concerns are unintended pregnancies and ectopic pregnancies. In an ectopic pregnancy, the embryo implants somewhere other than the uterus, and this can be life threatening. Women have also experienced migration of the device from the fallopian tubes, organ perforation, chronic pain, and allergic reaction to the nickel in the coils. In a few cases, the coils have been expelled. Some women have had the coils removed to alleviate side effects. NPR reports that a Facebook group for Essure users has drawn thousands of posts from women who have experienced symptoms they attribute to the device.
In May, Bayer released data from a long-term study that it said supports the safety and efficacy of Essure. According to this study, the device caused pelvic pain in only 7 percent of participants in the study. But an article in the New York Times called the company’s data into question. The Times cited a long-term trial published in the Journal of Minimally Invasive Gynecology. Only 366 out of 518 original study participants were followed for the full five years, according to the Times. And women who were tracked cited a number of problems tied to the device, including unusually heavy periods and recurrent pelvic pain.
The FDA panel will gather scientific and clinical opinion on the risks and benefits of Essure, as well as comments and written testimony from women who have used Essure. The committee will evaluate the evidence about the safety and effectiveness of Essure, and will provide recommendations to the FDA about appropriate use of the device, product labeling, and the potential need for additional post-market clinical studies.
The panel meeting will be held at the FDA’s campus in Silver Spring, Maryland and will be open to the public.
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