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A Public Broadcasting Service (PBS) “Need to Know” series recently discussed vaginal mesh complications, which have affected thousands of women implanted with the controversial medical devices. PBS correspondent, Dr. Emily Senay, spoke with Linda Gross of South Dakota who experienced serious and devastating vaginal mesh complications she says have changed her family, her life, and her career. With the help of experienced vaginal mesh lawyers, Gross was able to obtain compensation for her injuries. But thousands of women still await their day in court. Complications are Catastrophic, Often Long-Term, Permanent According to the “Need to Know” broadcast, Gross was diagnosed with pelvic organ prolapse (POP) about seven years ago and was implanted, on her physician’s advice, with Ethicon’s Gynecare Prolift, a then-new transvaginal mesh device developed by Johnson & Johnson’s Ethicon unit. She was advised by her physician that the quick surgery would be minimally invasive and, if her body rejected the vaginal mesh, it could be easily removed. The surgery was deemed successful; however, her recovery proved catastrophic. Five months later, Gross sought surgical removal of the mesh, but by that time, her body’s tissues became entangled with the implant. The removal process was now a complex series of procedures that, in Gross’s case, involved 22 surgeries. Even now, parts of the mesh remain. Vaginal mesh is approved for the surgical treatment of POP and stress urinary incontinence (SUI). Implanted under the vaginal skin, pelvic mesh supports a weakened vaginal wall in women diagnosed with POP, or supports the urethra or bladder neck in SUI procedures. Sadly, vaginal mesh lawyers say Gross’ experience was not an isolated event. In 2011, the U.S. Food & Drug Administration (FDA) warned of a fivefold increase in reports of vaginal mesh complications, prompting the agency to change its stance that such problems were rare. The product Gross received, and others named in lawsuits throughout the country, were approved through the U.S. Food and Drug Administration’s (FDA) 501(k) process. In this process, approval is quickened with no clinical trials and is used when a device deemed low-to-moderate risk is found to be significantly similar to an already-approved, or “predicate,” device. Today, the FDA is investigating vaginal mesh products, and is considering making those designed for POP repair ineligible for 510(k) approval. Vaginal Mesh Lawsuits Pending throughout the Country Ultimately, Gross and her husband hired a vaginal mesh lawyer and filed a lawsuit against Ethicon and Johnson & Johnson. The case went to court in February 2013, and she was awarded $11.1 million in compensatory and punitive damages. More than 4,000 lawsuits have been filed against Ethicon and Johnson & Johnson over their transvaginal mesh devices; an additional 10,000 lawsuits have been brought against other mesh manufacturers. More trials are expected to begin in the summer of 2013.
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