The Food and Drug Administration (FDA) has directed Bayer to add a so-called black box warning to the Essure permanent birth control device. This is the agency’s most serious label warning for a drug or medical device. Hundreds of women have reported serious and painful complications they say were caused by Essure.
The FDA declined to withdraw Essure from the market altogether, saying Essure is safe and effective for many women although some women experience “very serious and sometimes debilitating problems,” the New York Times reports. But in mid-November, the agency ordered Bayer to add a boxed warning to the Essure packaging, saying Essure could cause the kinds of injuries women have reported.Essure Background
Essure is a permanent, non-surgical sterilization method, which received FDA approval in 2002. Two small coils made of a nickel alloy are inserted in the fallopian tubes through the vagina. The coils provoke an inflammatory response that causes scar tissue to form and block the tubes. The process can take up to three months and the tube blockage must be confirmed by a scan before the woman can stop using other birth control.
Essure is the first sterilization procedure for women that can be done in a doctor’s office, without an incision and without general anesthesia. The new device offered an alternative to tubal ligation, the surgical sterilization procedure commonly referred to as having the “tubes tied.”
The FDA approved Essure after clinical trials lasting only a year or two, although the device was intended to last for life. Essure could not always be successfully implanted, and the device failed to block the tubes in a significant percentage of patients. According to the checklist, nearly one in 10 women who try Essure cannot rely on it to prevent pregnancy. By the end of 2015, the FDA had received nearly 10,000 reports of injuries and pregnancies related to the device, and a small number of fatalities.
Women who have Essure implanted have reported a variety of adverse effects to the FDA including:
- perforation of the uterus or fallopian tubes
- device migration
- nickel allergy
- unintended pregnancy
- ectopic pregnancy (pregnancy outside the uterus)
A number of women have become pregnant even with Essure in place. While some of these women have had successful pregnancies and healthy deliveries, others have experienced complications and miscarriages. Women who become pregnant with Essure in place have a greater risk the embryo implanting outside the uterus (ectopic pregnancy), which may be life threatening if not detected promptly.
Calls to Remove Essure from the Market
In September 2015, in response to Essure complaints and a social media campaign assisted by activist Erin Brockovich, the FDA convened a meeting of the Obstetrics and Gynecology Devices Panel. The purpose of the meeting was to collect and discuss scientific data about Essure’s safety and effectiveness; to hear scientific and clinical opinions on the risks and benefits of the device; and to hear the experiences of women implanted with Essure.
Typical of women’s complaints about Essure injuries, is the case of a Mississippi woman who told the FDA she had to stop riding in in rodeo-style horse races because of intense pain after she had Essure implanted. The Essure coils had pierced her fallopian tubes and the woman’s doctor removed the implants, but the pain did not subside. The woman eventually had a hysterectomy and after the surgery, the surgeon discovered a piece of one of the coils still embedded in the woman’s uterus, the Times reports.
Earlier this year, the FDA approved a postmarket study plan that it believes will help the agency “better understand complications associated with the Essure device.” Bayer will follow 1,400 women implanted with Essure for five to six years. The first study report will be made in March 2017 and the final results are due 2023, according to the Times.
Bayer has revised the physician instructions and device labeling consistent with the FDA’s recently finalized guidance. A Patient Decision Checklist provides key information about Essure use, and the device’s safety and effectiveness. Bayer made important modifications to the patient counseling and device removal sections of the labeling to provide physicians with additional guidance in these critical areas.
Legal Help for Those Harmed by Essure
If you or someone you know has experienced injuries or complication after the implantation of Essure, please contact the attorneys at Parker Waichman LLP for a free, no obligation evaluation of your case. To reach the team of experienced device injury attorneys, fill out the firm’s online form or call 1-800-YOURLAWYER (1-800-968-7529).