Brazil Pulls Controversial Essure Birth Control Device from the MarketMay 2, 2017
Although Bayer Healthcare faces considerable pressure to withdraw the Essure permanent birth control device from the market, the company has not yet taken such action. Earlier this year, Brazil's National Health Surveillance Agency, Anvisa (Agencia Nacional da Vigilancia Sanitaria) suspended Essure from the Brazilian market.
Brazil's official gazette reported that Anvisa suspended the importation, distribution, marketing use and dissemination of the Essure system and also recalled Essure devices that had already been distributed. It was not clear whether the recall would extend to the removal of devices that have already been implanted, Modern Healthcare reports.
Brazil approved Essure in 2009, according to a 2011 regulatory report filed by Conceptus, the company that developed and original marketed Essure. Bayer acquired Conceptus in 2013.
Essure is the first birth control device of its kind, a non-surgical form of sterilization that was approved by the U.S. Food and Drug Administration (FDA) in 2002. Before Essure came to market, permanent birth control required surgery to sever the fallopian tubes.
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 woman's fallopian tubes are blocked and she cannot become pregnant. But unless the blocked tubes are 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 currently available to women.
Personal injury firm Parker Waichman notes that thousands of women have sent reports of Essure complications to the FDA since the device came to market in 2002.
In lawsuits and reports to the FDA, women say they have suffered serious Essure complications, including:
- abdominal pain
- pelvic pain
- back pain
- device migration
- weight gain
- heavy menstrual bleeding
- irregular menstrual cycles
- metal allergy
- organ perforation
- unplanned pregnancy
In addition, women have reported ectopic pregnancy-where the embryo implants outside the womb. Ectopic pregnancy can be life threatening if not detected soon enough.
As of the end of January 2017, 3,700 Essure lawsuits had been filed in the U.S. According to Modern Healthcare, anecdotal evidence suggests that fewer women are choosing Essure. Dr. James Greenberg, an OB/GYN at Brigham-Faulkner OB/GYN Associates in Boston, told the business and research website that he had been implanting two or three Essure devices per month, until recently. "If I put in one in the past year, I'd be surprised. " Greenberg said demand started to decline as "lawsuits started going up." Greenberg explains that "the average medical consumer today goes right to the web." When a woman searches for Essure, Greenberg said, "the first thing that comes up is lawsuits." Such information does not inspire women's confidence in Essure.
FDA Black Box Warning
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, although many women felt the warning was not strong enough in light of the injuries and complications women have reported. The FDA's Manufacturer and User Facility Device Experience (MAUDE) database has logged about 10,000 reports from physicians and patients, ranging from severe pain and device migration to autoimmune responses to the device. The reports include four women's deaths linked to Essure.
In June 2016, U.S. Representatives Mike Fitzpatrick Louise Slaughter introduced legislation to remove Essure from the market. H.R. 503, popularly known as Ariel Grace's Law, is named for a child who was stillborn at 27-28 weeks gestation. Her mother became pregnant despite having had Essure implanted to prevent pregnancy. Ariel Grace's Law would take Essure off the market and would also eliminate a federal preemption law that has protected Bayer from liability in a number of Essure lawsuits.
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).