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FDA Panel To Decide If The Risks of Women’s Surgical Mesh Are Too High To Keep On The Market

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Surgical mesh, either made of synthetic polymers or biopolymers is a material used to reinforce tissue or bone in female pelvic reconstructive surgeries.

It is also at the center of thousands of lawsuits from women who have experienced life-altering pain, sexual dysfunction, infections, tearing of organs, bleeding, and more.

Various types of surgical mesh including mesh slings have been implanted permanently into the pelvic area to typically repair pelvic organ prolapse (POP), hernia repair, and stress urinary incontinence (SUI). It was used in an estimated 300,000 surgical procedures for POP and SUI in 2010. Although there are other treatment options for these conditions, surgical mesh is viewed as a more permanent solution by some surgeons.

The FDA panel brought in medical experts to advise on whether to keep synthetic surgical mesh on the market after numerous reports of maladies from patients.

Billions of dollars have been awarded to victims of vaginal mesh or surgical mesh in personal injury lawsuits. Victims suffered crippling life-pain and had to have multiple surgeries in many cases as a result of the surgical mesh.

Vaginal mesh was first approved to go to market by the FDA in 1996, when the standards for medical devices were less stringent. After two public health notices released by the FDA in 2008 and 2011, advising the public on the serious complications of surgical mesh in some cases, the FDA panel is requiring that the two companies manufacturing surgical mesh products conduct clinical studies proving that the benefits outweighs the risks. These two companies are Boston Scientific and Coloplast Corp.

A recent study found more than 10,000 injury cases that could be linked to surgical mesh as well as 77 possible linked deaths. For information about how to file a surgical mesh personal injury lawsuit, send us a message.

 

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Clare Lithgow

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