Women who wish to avoid pregnancy without tubal ligation or using hormonal birth control may undergo the Essure® sterilization procedure. While Essure’s manufacturer, Bayer, touts Essure as less invasive than getting fallopian tubes tied, it has serious complication risks. Much like other, similar surgically implanted medical devices, Essure can migrate, fracture and perforate a woman’s internal tissues and organs. Despite Bayer’s claim that Essure is 100% effective for contraception after three months, women reported ectopic pregnancies and fetal deaths. Since Bayer didn’t disclose some complication risks, injured women may file an Essure lawsuit against the manufacturer for negligence.

What is Essure?

Essure permanent birth control includes a pair of soft, flexible metal coils inserted into the fallopian tubes to prevent pregnancy. Three months after a gynecologist inserts both coils, Essure is supposedly 100% effective for contraception. Essure works by triggering a process called fibrosis, meaning scar tissue envelops both coils, creating a barrier that prevents fertilization. Most women who choose Essure already have children or are older and want to avoid invasive surgical procedures, including hysterectomy.

Bayer secured premarket approval for Essure in 2002 from the U.S. Food and Drug Administration. Due to passing the FDA’s supposedly rigorous premarket approval process, Bayer is legally protected from any Essure lawsuit liability claims. However, injured women filing adverse event reports with the FDA are making Essure lawsuit allegations of negligence against Bayer.

Essure Lawsuit History

Heather Walsh filed the first Essure lawsuit against Bayer in 2013. According to court documents, Walsh scheduled the Essure procedure in 2008 with a Bayer representative present to supervise her doctor. Unfortunately, the Bayer rep never showed, and her doctor’s initial device insertion attempt failed. After several failed implantation attempts, her doctor finally succeeded at placing both Essure coils in Walsh’s fallopian tubes. Over the next two years, Walsh was hospitalized four times for severe pain, fainting, and fever. Finally, a CT scan revealed the problem: An Essure coil migrated into Walsh’s abdomen and became lodged behind her colon. Worse, the technician discovered three Essure coils instead of two. Ultimately, Walsh needed multiple surgeries to remove the migrated Essure device from her colon as well as a hysterectomy. Today, Walsh still suffers constant pain and autoimmune disorders allegedly caused by her faulty Essure permanent birth control implant.

After Walsh filed her Essure lawsuit, thousands of women soon followed in her footsteps. Despite Bayer’s legal preemption status, judges are approving Essure lawsuit claims to go forward in courts across the country. This is due to the severity of complications and number of plaintiffs involved (Bayer currently faces 3,700 Essure lawsuit claims).

In September 2016, U.S. District Court Judge Winifred Y. Smith approved an Essure mass tort request in California. In other words, one judge will oversee every Essure lawsuit filed in California at the state level. However, unlike a class action lawsuit, each individual Essure lawsuit claim involved in litigation remains independent.

Current Essure Lawsuit Allegations Against Bayer

Although Bayer has immunity from product liability claims, injured women may still file an Essure lawsuit for negligence. In April 2016, Pennsylvania U.S. District Judge John R. Padova ruled Essure lawsuit claims filed against Bayer could move forward. In other words, the PMA laws Bayer cited may not always apply.

Among Essure lawsuit claims currently pending, many plaintiffs share similar allegations, including:

• Medical malpractice
• Negligence in manufacturing and marketing a faulty medical device
• Wrongful death
• Failure to adequately train medical professionals on proper Essure placement techniques and device risks
• Fraudulently concealing adverse event reports from the FDA during the premarketing approval stage
• Failure to disclose Essure migration, perforation and ectopic pregnancy risks from consumers and healthcare providers
• Conspiracy to engage in misconduct for enrichment purposes at the expense of plaintiffs’ health as well as financial well-being
• Breach of express warranty
• Failure to warn about potential allergy and autoimmune responses to Essure, including metal toxicity and nickel hypersensitivity (a warning that the device’s original developer, Conceptus, successfully petitioned the FDA to remove from Essure’s packaging and labels in August 2011)

Could The FDA Recall Essure Over Safety Concerns?

Public outcry over Essure grew so loud in 2015 that both consumer advocacy groups and elected officials finally stepped in. Despite the FDA’s refusal to issue an Essure recall, Pennsylvania congressman Mike Fitzpatrick ordered an independent review in April 2016. Working alongside former Device Events CEO Madris Tomes, they discovered more than 10,000 Essure adverse events in the FDA’s database. That’s nearly twice as many as the previously reported number (5,093) filed since 2002. In addition, the agency failed to report more than 300 fetal deaths in women implanted with Essure.

Congressman Fitzpatrick introduced the E-Free Act in 2015 and the Medical Device Guardians Act and Ariel Grace’s Law in 2016. To date, no bill has yet made it through both houses of Congress. However, thousands of women’s health advocates and injured Essure patients are fighting to get Essure pulled completely off the market. In the past year alone, Bayer says it lost $413 million in revenue fighting Essure lawsuit claims.