Yale researchers evaluate safety of popular sterilization method

A recent study co-led by Yale researchers in collaboration with peers at the University of California, San Diego found that hysteroscopy, a banned popular birth control method of sterilization, is not “generally harmful.”

When the U.S. Food and Drug Administration, FDA, first approved hysteroscopic sterilization in 2002, it was advertised as a less invasive type of permanent contraception called Essure. Initially, it was considered a turning point in birth control, but after thousands of adverse effects including pelvic pain, abnormal bleeding and the need for additional surgeries following the Essure procedure were reported, the FDA mandated a clinical trial to reassess the product’s safety. Essure was discontinued in 2018, and the study was ultimately left unfinished.

The paper detailing this current study’s findings was published on Feb. 3 in Obstetrics and Gynecology. It details that the procedure itself is not generally harmful. This research was led by Aileen Gariepy, associate

Latest Bayer Report Shows Thousands More Essure Adverse Events

When Bayer announced in July 2018 that it would stop selling the permanent birth control device Essure, the U.S. Food and Drug Administration (FDA) required the company to continue to evaluate long-term safety information in women who received the device.

According to the latest analysis from Bayer covering the period of June 1, 2020, through August 31, 2020, there were an additional 7,509 events related to the Essure reported to the FDA’s medical database, including 7,332 serious injury reports, 104 malfunction reports, and 73 death reports. The most common patient problems reported included pain, perforation, foreign body/device fragment in the patient, pregnancy, and heavier periods.

The FDA added that the limited information on the reports provided by Bayer “prevents the ability to draw any conclusions as to whether the device or its removal, caused or contributed to any of the reported deaths or other events in the reports.”

Bayer Indicates Progress in Essure Settlement Talks

Victims of Essure birth control implant injuries may soon get the compensation they deserve. Manufacturer Bayer has indicated it is making progress in settlement talks with plaintiffs’ lawyers, and that it has set aside $1.47 billion for potential settlements involving approximately 32,000 lawsuits pending around the country.

Essure is a form of permanent birth control that Bayer sold from 2002 through 2018, after which the company stopped distributing the product in the U.S. because of restrictions implemented by the U.S. Food and Drug Administration (FDA).

Bayer Considering Settlements, but Maintains Essure is Safe
As of July 24, 2020, Bayer faced roughly 32,000 lawsuits filed by Essure users claiming to have suffered from serious injuries caused by the birth control device, including hysterectomy, pain, bleeding, perforation, unwanted pregnancy, and more. The plaintiffs seek both compensatory and punitive damages.

Bayer recently indicated in its second-quarter results announcement that it had seen progress in recent settlement talks: “Recently discussions on potential settlements have intensified which made good progress in recent weeks.” The company added that it continues to “support the safety and efficacy of the Essure device and are prepared to vigorously defend it in litigation.”

Bayer to pay $1.6 billion to settle thousands of Essure injury claims

The German pharmaceutical giant Bayer has agreed to pay $1.6 billion to settle tens of thousands of United States claims related to its birth control device Essure.

Nearly 39,000 women across the U.S. had claims against Bayer after suffering health problems including severe pain, bleeding and organ damage after being implanted with the device, a contraceptive coil that is placed in the fallopian tubes. The settlement will resolve roughly 90% of these claims, Bayer said in a statement last week.

The agreement did not include an admission of wrongdoing or liability by Bayer, and plaintiffs who participate will be required to drop their claims.

“Bayer sympathizes with all women who have experienced adverse health conditions, regardless of the cause, but the company continues to stand by the science supporting the safety and efficacy of Essure,” Bayer said.

The settlement provides a coda to years of controversy that have surrounded Essure.

Essure Birth Control Lawsuit

Essure lawsuits claim Bayer failed to warn patients of severe device side effects. Users suffered uterus perforation, device breakage, autoimmune disorders and fetal death. At least 39,000 Essure lawsuits have been filed. No settlements have been made.

Why Are Women Filing Essure Lawsuits?

We are helping women sue Bayer after experiencing complications with the company’s Essure sterilization device. Complaints range from problems caused by broken devices, device migration, and even expulsion of the contraceptive implant in some cases.

As part of the complaint, many women are seeking damages for the costs of medical care to treat symptoms and complications of the device’s malfunction, along with related expenses. Many women also are seeking non-economic damages related to pain and suffering, including mental and emotional anguish, as well as punitive damages to punish Bayer for developing, manufacturing, and promoting an unsafe medical device.

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