Essure Birth Control Lawsuit. Dozens of women have come together to file a lawsuit against Bayer Healthcare over serious side effects they suffered with the Essure birth control system.
Essure is the first birth control device of its kind, a non-surgical form of permanent birth control, approved by the U.S. Food and Drug Administration (FDA) in 2002. The device consists of two small, flexible metal coils that are inserted through the vagina 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. Before Essure came to market, permanent birth control required surgery to sever the fallopian tubes.
Personal injury firm Parker Waichman notes that thousands of women have reported Essure complications to the FDA since the birth control system came to market in 2002.
Thousands of women who have had Essure inserted report serious side effects. The women say Bayer downplayed the true safety risks of Essure. Bayer Healthcare has marketed Essure as a safer, simpler, and more effective method of permanent birth control than other options currently available to women.
Conceptus Inc., acquired by Bayer in 2013, began development of Essure in 1998. Plaintiffs say the company was hundreds of millions of dollars in debt and Conceptus hoped a substantial U.S. market for Essure could help pull the company out of debt.
Because Essure was the first birth control device of its kind, the medical community would have understandable concerns about a device. Plaintiffs claim that in order “to promote the perceived safety of the device and gain market acceptance, Conceptus devised and implemented a scheme to defraud physicians and patients, by means of false and fraudulent pretenses, representations and concealment of material facts.” Conceptus marketed Essure as a simple permanent birth control solution that was safer than other alternatives. But the lawsuit alleges that Conceptus and Bayer knew of the serious dangers linked to Essure, and the companies allegedly withheld significant information about Essure risks.
Essure Side Effects
In Essure lawsuits and reports to the FDA, women say they have suffered serious Essure complications, including:
- device migration
- abdominal pain
- pelvic pain
- back pain
- weight gain
- heavy menstrual bleeding
- irregular menstrual cycles
- metal allergy
- organ perforation
- unplanned pregnancy
- ectopic pregnancy (pregnancy outside the uterus)
Essure migration and organ perforation are among the most dangerous Essure side effects. If the device migrates from its proper location and perforates an organ this can lead to infection and dangerous complication. Because Essure is a permanent form of birth control, the coils cannot usually be removed. Some women have needed a hysterectomy to remove Essure.
Since Essure received FDA clearance, the agency has received more than 4,500 adverse event reports involving Essure. 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. The adverse events reported associated with the use of the Essure System include persistent pain, perforation of the uterus and/or fallopian tubes, intra-abdominal or pelvic device migration, abnormal or irregular bleeding, and allergy or hypersensitivity reactions. Some women have had surgical procedures to remove the device.” In addition, because of “incomplete patient follow-up,” some women have become pregnant, the FDA said. 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.
In June 2016, U.S. Representatives Mike Fitzpatrick Louise Slaughter introduced the E-Free Act to Congress. This bill, H.R. 503, popularly known as Ariel Grace’s Law, is intended to remove Essure from the market. The bill 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.