Essure Birth Control Lawsuit Claims Manufacturers Violated FDA Approval Requirements

An Arizona woman has filed a product liability lawsuit after experiencing problems with Essure birth control, alleging that the manufacturers of the sterilization implant have invalidated federal regulator’s approval of the device, suggesting that it should have never been sold to her.

The complaint (PDF) was filed earlier this month in the U.S. District Court for the Northern District of Californi by Danielle Patterson, indicating that Bayer’s ability to market the controversial Essure birth control implant rests on requirements in a Conditional Premarket Approval (CPMA) granted by the FDA.

Since Bayer and the original manufacturer, Conceptus, violated those requirements, Patterson maintains that Essure was “adulterated” and that the device manufacturers were precluded from selling the product, which allegedly endangered her life and the safety of the public.

“Defendants actively concealed these violations and never advised Plaintiff of the same,” indicates Patterson in the complaint. “Had Plaintiff known that Defendants were concealing adverse reactions, not using conforming material approved by the FDA, not using sterile cages, operating out of an unlicensed facility, and manufacturing medical devices without a license to do same, she never would have had Essure implanted.”

Essure Birth Control Safety Concerns

Essure is a birth control implant offered as an outpatient procedure by many medical facilities to provide permanent protection against pregnancy.

During the Essure procedure, a doctor inserts bendable coils into the fallopian tubes, passing through the vagina, cervix and uterus. The process causes scar tissue to form around the coils over several months, which blocks the tubes, preventing insemination.

In recent years, there have been growing concerns about the safety of Essure implants, with thousands of women reporting severe complications after receiving the device.

Between the date the birth control product was approved in November 2002 and May 31, 2015, the FDA has received at least 5,093 adverse events involving Essure complications.

Patterson’s lawsuit notes that the CPMA requires that the manufacturer report any adverse reactions to the FDA within 10 days of becoming aware of the problem, among other requirements.

“Defendants were cited by the FDA and the Department of Health for failing to report and actively concealing 8 perforations which occured as a result of Essure, erroniously using non-conforming material in the manufacturing of Essure, failing to use pre-sterile and post-sterile cages, manufacturing Essure at an unlicensed facility and manufacturing Essure for three years without a license to do so,” the lawsuit states. “These violations invalidated the CPMA, rendering the product ‘adulterated’ precluding Defendants from marketing or selling Essure per the FDA, and, more importantly, endangered the life of Plaintiff and the safety of the public.”

Patterson was implanted with an Essure birth control device in May 2009. Following the procedure, she began experiencing severe, constant, daily pain and severe bleeding, according to the complaint. She has suffered migraines, abdominal, ovarian, and pelvic pain, pain during intercourse, heavy bleeding and emotional and mental pain and anguish as a result of Essure complications, the lawsuit indicates.

The Essure birth control lawsuit accuses Bayer of manufacturing and designing a defective product, pursuing claims for negligence, failure to warn, strict liability, breach of warranty, negligent misrepresentation, fraudulent misrepresentation, fraud by concealment.

Essure Recall Proposed In Legislation

The lawsuit comes as Representative Mike Fitzpatrick made good on earlier promises to introduce legislation calling for an Essure recall and to ban the device from the market.

The E-free Act was introduced on November 4, and would require the FDA to withdraw approval of Essure as Patterson’s lawsuit recommends.

The calls to recall Essure came following a September 24 meeting of the FDA’s Obstetrics and Gynecology Devices Panel, which was focused on the safety concerns surrounding the birth control implant and reports of Essure complications suffered by a number of women who received the device. The hearing was marked by a parade of women who gave passionate testimonies on the damage the Essure implants have allegedly done to their bodies and their lives.

The advisory committee suggested that better safety data is needed, including a patient registry and a new clinical study on safety and effectiveness. They also said Bayer should provide women with more detailed information about the risks of Essure before it is implanted, suggesting that women have review a checklist of possible complications and sign off on it before getting the procedure.

Patterson’s complaint is one of the first of what many expect may be hundreds of Essure lawsuits that may be filed by lawyers across the country in the coming months and years, arguing that the birth control never should have been implanted in women.