Transvaginal placement of surgical vaginal mesh is a procedure that is used to treat Urinary Stress Incontinence (USI) and Pelvic Organ Prolapse (POP) in women. In October 2008, the Food & Drug Administration (FDA) warned that transvaginal placement of surgical mesh had caused serious and painful complications in hundreds of women.
Have you experienced injury or other complications due to a transvaginal mesh implant? It’s time that you got legal help. At Schlesinger Law Offices, P.A., our Fort Lauderdale vaginal mesh lawyer can help you fight for compensation that may cover medical bills, lost wages, pain and suffering, and more.
The original 2008 FDA safety notice proclaimed that transvaginal mesh side effects are rare, even though over 1,000 reports of complications were received by no less than nine transvaginal mesh manufacturers.
On July 13, 2011, the FDA issued an update on the original safety notice. The update states that transvaginal mesh side effects are not rare. The notice also states that no clear evidence shows that transvaginal mesh used in the treatment of POP is more effective than traditional treatments without the mesh.
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Erosion of Vaginal Tissue & Other Side Effects
Several transvaginal mesh side effects have been reported to and acknowledged by the FDA. The most common of these is that the mesh can erode vaginal tissue and puncture the vaginal wall. This side effect can be painful and cause other complications, including infection and permanent injury. The treatment of vaginal erosion may involve multiple debilitating surgeries to correct. Some women have not had the problem resolved even after undergoing several surgical procedures.
While vaginal wall erosion is the most common and consistently reported side effect, the FDA has stated that in their 2011 safety update that they are aware of several other transvaginal mesh side effects.
These Side Effects Include the Following:
- Organ perforation
- Urinary complications
- Painful intercourse
- Mesh Contraction
A previously unidentified transvaginal mesh side effect was included in the FDA safety update: mesh contraction. Mesh contraction occurs when transvaginal mesh begins to shrink after it has been implanted. This side effect can cause tightness and shortening of the vagina, resulting in pelvic discomfort and pain.
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 transvaginal 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 vaginal mesh attorneys have provided injured victims with the knowledgeable and passionate representation they need for the past six decades
I can't thank the team of lawyers from Schlesinger Law Firm for their high quality of professionalism and persistence in pursuing my lawsuit. They always made me feel part of their family.