FDA Investigates Fake Materials Claim In Transvaginal Mesh Lawsuit
April 07, 2016 – – TheProductLawyers.com reports on a recent article indicating that the FDA is aware of allegations against Boston Scientific that they used counterfeit materials to produce transvaginal mesh products.
According to the article, the FDA has stated that they are aware of the allegations and are currently investigating the claims. The issue came to light after law firm Mostyn Law sued Boston Scientific claiming that the company knowingly sourced counterfeit resin from China for the production of mesh. The FDA has stated, “We are examining these allegations to determine any necessary and appropriate next steps.” Boston Scientific has responded to the suit by denying the allegations.
The charges come among thousands of other suits concerning mesh products in which women have claimed that the products significantly altered their quality of life. The FDA approved transvaginal mesh in 1996 for use in stress urinary incontinence procedures and then again in 2002 for the treatment of pelvic organ prolapse. The material is usually made from non-absorbable synthetic polypropylene and is manufactured by several companies including C.R. Bard, Johnson & Johnson, Boston Scientific, Cook Medical and Coloplast Corp.
Side effects that have been alleged in these suits include bleeding, infections, organ perforation, recurrent prolapse or incontinence, severe pelvic or vaginal pain, a need for corrective surgery, vaginal scarring, vaginal shrinkage, inability to engage in sexual intercourse, erosion of mesh through the vagina and neuromuscular problems.
As more of these cases are expected to be brought to court, attorneys at Banville Law are working to make sure that those who believe they have suffered adverse side effects as a result of a transvaginal mesh implant are given the important opportunity to explore their legal rights fully. Qualifying individuals may be entitled to legal action and financial compensation. Banville Law is currently offering free case evaluations for those parties.
To learn more about transvaginal mesh, or to ask questions, contact Banville Law by calling (877) 671-6480.
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