Did You Suffer Serious Complications Caused By This Medical Device?
Gynecological mesh, also known as surgical mesh or transvaginal mesh, is a device that’s intended to provide extra support to damaged or weakened tissue. In most cases, it was used to treat conditions like stress urinary incontinence (SUI) and pelvic organ prolapse (POP), but is now considered a high-risk device by the Food and Drug Administration (FDA) after a growing number of reports of complications after or during surgery. Patients who suffered serious health complications after receiving these implants are now filing lawsuits, many saying that they suffer from serious pain – as of now, Boston Scientific, one of the largest manufacturers of gynecological mesh, is facing an estimated 48,000 lawsuits.
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What Are Some Complications Caused By Gynecological Mesh?
According to some medical professionals, the issue can arise once the antioxidant additives in the mesh’s plastic dissipate. The material this mesh is made of, polypropylene, can be broken up when exposed to oxygen. According to the National Center for Biotechnology Information (NCBI), complications caused by this type of medical device include:
- Organ perforation
- Urinary problems
- Vaginal scarring/shrinkage
- Neuromuscular problems
- Recurrent prolapse
These complications are not rare. According to an FDA report published in 2010, there were nearly 4,000 “reports of injury, death, and malfunction” over the five-year period the Administration investigated.
The Issue With Boston Scientific
A CBS News investigation into Boston Scientific’s actions revealed some startling information. According to the 60 Minutes report, the multi-billion dollar medical device maker faced a serious supply issue back in 2004 – at the time, it was using a brand of polypropylene known as Marlex to create its mesh product. That year, the Marlex manufacturer, Chevron Philips, issued a warning that its product must no longer be permanently implanted inside humans anymore, despite prior clearance to from the FDA.
Boston Scientific was no longer allowed to purchase this material from Chevron Philips starting in 2005. When this decision was appealed by Boston Scientific, the manufacturer responded that,
"We are simply not interested in this business at any price."
Boston Scientific has enough Marlex stockpiled to last through 2012, but the company had a significant financial stake in ensuring that it could continue to use this FDA-accepted material after that, despite the warnings over its potential health risks. After contacting nearly two dozen companies across the globe with no success, Boston Scientific settled on a company based in China, though this product came with significant red flags like tests that showed not all of the mesh was made of the same material.
"This is an experimental material,” said Dr. Michael Margolis, a surgeon who has removed 350 implants and has been a witness in lawsuits against Boston Scientific. “Implantation of this into anyone is human experimentation but without consent. Because this is novel material. We don't know how this affects humans, it's never been tested before."
You can read or watch the full 60 Minutes report here. Reporters uncovered a considerable paper trail that includes some of the most senior members at Boston Scientific, and decisions that were questionable at best.
Hire A Law Firm You Can Trust
If you suffered serious complications caused by gynecological mesh distributed by Boston Scientific, you may be able to seek legal action to secure the compensation you deserve. At Schlesinger Law Offices, P.A., our Fort Lauderdale personal injury attorneys have provided injured victims with the knowledgeable and passionate representation they need for the past six decades. Call us at (954) 467-8800 to discuss your situation with a member of our firm, or fill out our online form to start out with a free case evaluation today.