Articles Tagged with product liability

medical malpractice attorneys

FDA Says Surgical Mesh Manufacturers Must Stop Selling Unsafe Devices

On April 16, 2019, The U.S. Food and Drug Administration (FDA) ordered two manufacturers of three different vaginal mesh products to immediately stop selling and distributing their products for not meeting U.S. premarket standards for high risk devices. The FDA also said there was insufficient evidence that the mesh worked better than surgery to repair pelvic organ prolapse (POP).

The three vaginal mesh devices are:

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Willowbrook Sterigenics Investigated for Emitting Invisible Cancer-Causing Gas to Residents and Workers

The U.S. Environmental Protection Agency (EPA) is headed to the neighborhood of one of Levin & Perconti’s founding partners, John Perconti, to perform “ambient air testing” at the Willowbrook Sterigenics facility in DuPage County. Sterigenics is a global company which runs contract business for sterilization services. The Willowbrook facility, currently at the center of a toxic emissions review, sterilizes medical devices such as syringes and surgical procedure kits. The emission in question, Ethylene Oxide (EtO), is a known carcinogen and airborne substance identified as troublesome and cancer-causing for residents and workers who are ongoingly exposed. In 2007, the EPA issued standards to reduce emissions of EtO from hospital and medical device sterilizers to protect workers and community residents from damaging air pollutants.

An August 2018 public report prepared by the U.S. Department of Health and Human Services, Agency for Toxic Substances and Disease Registry (ATSDR) titled “Evaluation of Potential Health Impacts for Ethylene Oxide Emissions” showed workers and residents who live nearby Sterigenics have been exposed to elevated airborne EtO concentrations. The ATSDR further concluded that “an elevated cancer risk exists for residents and off-site workers in the Willowbrook community surrounding the Sterigenics facility,” and that “these elevated risks present a public health hazard.” ATSDR officials have put forth the recommendation that Sterigenics “take immediate action to reduce EtO emissions at this facility.”

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