Essure Battle ends in 16,000 lawsuits

The Washington Post called the fight to get Essure off the market a “protracted battle.” The Post reported, “in recent years thousands of women who opted for Essure for permanent birth control developed complications. They chose it instead of having “their tubes tied,” an operation that was the only other method of permanent birth control. In 2018, the pharmaceutical giant Bayer quit selling Essure in the U.S., the last country where it was available.

In 2018, a CNN expose revealed Bayer was paying doctors to promote Essure. A professor of surgery and patient safety at Johns Hopkins Medicine told CNN it’s “ethical” for drug companies to pay a doctor for “genuine research,” but he doubted “the more than 11,000 doctors paid by Bayer were involved” in research. Dr. Martin Makary told the national news network, the payments looked “like a bribe,” He likened it to “gaming the system.”

Essure’s coils are hard to remove if they malfunction

While Essure’s side effects are rare, they are serious and can be fatal. The BMJ, a highly-rated medical journal published in England, reported in 2015 that Essure’s coils can cause intense abdominal pain, severe allergic reactions and hemorrhages. They can dislodge and puncture the fallopian tubes where they are implanted, the uterus, and the abdomen. There’s a higher risk of pregnancy when Essure fails. Ectopic pregnancies associated with it can be fatal.

After interviewing medical experts in a 2017 investigation of the contraceptive device, Consumer Reports found that “doctors have been slow to recognize the trouble with Essure, and in many cases,” they were unprepared to treat women “who want or need the device removed.”

The magazine reported that “roughly half of the 17,000 adverse-events involving Essure” needed surgery, up to and including a full hysterectomy, to take out its coils. But they weren’t designed to be removed and when doctors try, they can break into small pieces, sometimes requiring a second surgery. Three Yale-based physician researchers quoted in the article said Essure “is just one example of “substandard data” being used to approve medical devices.

Critics of the U.S. Food and Drug Administration’s approval process urged the federal agency for years to take Essure off the market. In 2016, 14 years after it first approved Essure, the FDA put a Black Box warning on it and restricted sales of it in 2018 “to further protect women.”

Wayne Wright can help Essure’s victims

For 40 years, Wayne Wright has been helping victims recoup damages, pay medical bills and be reimbursed for pain and suffering when they have been injured by a bad medical device or drug. Wayne Wright is one of America’s top trial lawyers. His many national legal honors are based on the top awards he has won for clients. Calls and evaluations are free. Clients only pay a fee, agreed upon in advance, when Wayne Wright wins their case.