Breaking News: Bayer Discontinues Sales of Birth Control Device Essure

By the end of 2018, Bayer HealthCare will stop selling Essure—a contraceptive device that has caused severe injuries and complications for thousands of women. Marketed as a permanent, nonsurgical method of contraception, Essure has caused debilitating adverse side-effects including chronic pain, pregnancy, miscarriage, perforation of the uterus or other organs, and even death. From 2002, when Essure was approved by the FDA, to the end of 2017, the agency had received at least 27,000 reports of adverse events relating to Essure.

In April 2018, the FDA restricted Bayer’s sales of Essure to health care providers that agreed to fully inform and review the device’s risks with patients. Two years prior, the safety regulator issued a “black box” warning on the product, the most stringent caution, outlining serious injuries that could result from using the device.

Cases on behalf of thousands of women have been filed against Bayer, claiming the manufacturer did not warn patients of Essure’s potential severe complications. Grant & Eisenhofer is Co-Liaison Counsel and serves on the Plaintiffs’ Executive Committee leading the litigation. If you have experienced complications from an Essure implant, please call us at 888-985-7228 to speak confidentially with an attorney about your potential claim.

Grant & Eisenhofer Attorneys Provide Guidance on Medical Monitoring Claims

In the July 2018 issue of Trial magazine, Grant & Eisenhofer director Beth Graham and associate Stephanie Riley weigh in on factors to consider when filing a medical monitoring claim. Individuals who have had defective medical devices implanted, but not removed, may be at risk for injury and eligible to file a medical monitoring claim. Eight states and the District of Columbia allow these types of claims. According to Graham and Riley, in many cases, lawyers will seek to certify a class consisting of a large group of claimants eligible to receive compensation. For a case to become class certified, claimants must have the same device and “typical” or sufficiently identical injury claims. To speak with an attorney about your potential claim, please call us at 888-984-7988.

Stryker Expands LFIT V40 Safety Notification

Metal-on-metal hip implants manufactured by Stryker Orthopedics have been the subject of safety alerts and recalls in the past several years. Since the company’s August 2016 notification concerning its LFIT V40 femoral head, indicating a higher-than-expected number of complaints concerning the device, Stryker has expanded its safety notification to include eight additional products that include the device. Problems with the Stryker device may include pain associated with device loosening, dislocation, fracture, leg length discrepancy, inflammation, and pain requiring revision surgery.

If you or a loved one has experienced complications after receiving a metal-on-metal hip implant, please contact us by calling us at 877-790-3588 for a confidential evaluation of your potential claim.

“60 Minutes” Reports on Unsafe Gynecological Mesh Plastic

Over 100,000 women have filed more than 48,000 lawsuits alleging that Boston Scientific’s gynecological mesh inflicts serious pain and injury. The mesh product is a plastic implant designed to relieve urinary incontinence and support organs post-pregnancy. According to a “60 Minutes” report that aired in May 2018, these lawsuits “make up the largest multi-district litigation since asbestos.” Experts consulted for the program said that the plastic in the mesh used by Boston Scientific was provided by a broker in China, and is unsafe for the human body. “I can’t, in my wildest imagination, imagine anybody that’s knowledgeable in the science of plastics ever deciding that it was appropriate to use polypropylene in the human body,” said plastics engineer, Duane Priddy. Patients described their side-effects from the device to include inflammatory reactions and “shooting, uncomfortable pain.”

FDA Takes New Measures to Inform Women of Essure Risks

In April 2018, a national movement of women suffering from painful side effects caused by Essure achieved two major victories: On April 9th, the FDA ruled that health care providers can no longer implant Essure unless the doctor and patient review and sign an FDA-approved document outlining the risks. The following week, the FDA announced new guidelines in approving medical devices for U.S. patients.

FDA Commissioner Scott Gottlieb noted that some women receiving Essure have not been fully informed about the risks associated with it: “Despite previous efforts to alert women to the potential complications of Essure, we know that some patients still aren’t receiving this important information.”  Even with warnings in place, Essure is still available in the U.S., though it has been removed from the market in other countries.

If you or a loved one has been hurt by the Essure implant, please call our attorneys at 888-985-7228 for a confidential evaluation of your potential claim.

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