Essure

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.”

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.

Essure Lawyers Request MDL to Centralize Lawsuits

Plaintiffs requested the U.S. District Court for the Eastern District of Pennsylvania, where Judge Gerald Austin McHugh, Jr. currently presides over three cases.

Approximately 30 lawsuits are pending in Pennsylvania, California, Connecticut, Missouri, and Idaho — with thousands more expected. Essure was implanted in over 750,000 women and the FDA has received 5,000 adverse event reports.

Lawyers want to create a Multi-District Litigation (MDL), which is like a class action. It helps coordinate discovery, trials, and settlements, while allowing each individual lawsuit to remain independent.

Essure is a permanent sterilization device made by Bayer that consists of two metal coils. It is inserted into the fallopian tubes, causing scar-tissue to grow and block sperm from fertilizing an egg.

Lawsuits accuse Bayer of failing to warn about side effects. In February, the FDA placed a “Black Box” warning label on Essure and ordered Bayer to conduct new safety studies.

Essure Birth Control Lawsuit Settlement

In August 2020, Bayer announced it would pay $1.6 billion to end virtually all of the U.S. Essure lawsuits involving women who claimed the birth control device caused serious health complications. The Essure settlements will resolve about 90 percent of the nearly 39,000 claims. Bayer had stopped selling Essure in 2018 but did not recall the device.

Thousands of American women filed lawsuits against Bayer after they say Essure caused devastating side effects and ruined their lives. Lawsuits say Bayer failed to report serious side effects such as perforated organs and broken devices to the U.S. Food and Drug Administration and to the public.

For many women, Essure side effects started immediately after implantation. In lawsuits, some say their devices moved out of the fallopian tubes and cut into nearby organs. Others say their device broke into pieces and wreaked havoc on their bodies.

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