FDA seeking to classify transvaginal surgical mesh as ‘high risk device’

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by Michael Heygood

The U.S. Food and Drug Administration has issued two proposed orders to address the health risks associated with surgical mesh used for transvaginal repair of pelvic organ prolapse. First, the FDA is proposing to reclassify transvaginal surgical mesh from a moderate-risk device (class II) to a high-risk device (class III). Second, the FDA is proposing to require mesh manufacturers to submit a premarket approval application for the agency to evaluate safety and effectiveness of such mesh products.

Pelvic organ prolapse occurs when the internal structures that support the pelvic organs such as the bladder, uterus and bowel become so weak, stretched, or broken that the organs drop from their normal position and bulge (prolapse) into the vagina. Women with pelvic organ prolapse (“POP”) often experience pelvic discomfort, disruption of their sexual, urinary, and bowel functions.

Surgical mesh is used to provide additional support when surgically repairing weakened or damaged tissue. Surgeons thread the mesh devices through incisions in the vagina to fortify pelvic muscles that failed to support internal organs or to treat incontinence. In just 2010, at least 70,000 mesh devices were surgically implanted in the United States.

Starting as early as 2008, there have been safety concerns about transvaginal mesh products. In October 2008, the FDA warned of complications for patients who receive surgical mesh to treat stress urinary incontinence and pelvic organ prolapse. Later, a second FDA warning stated such complications from mesh products were far more common than had been previously thought.

Women who have undergone surgery with mesh have experienced serious complications, including severe pain, infection, bleeding, pain during sexual intercourse (dyspareunia), organ perforation, urinary problems, and vaginal mesh erosion. Thousands of transvaginal surgical mesh lawsuits have been filed involving more than 50 different brands of implants. Manufacturers involved in mesh lawsuits include Johnson & Johnson, Boston Scientific, C.R. Bard, Gynecare, and American Medical System

Many mesh products come in kits that include instruments specifically designed to aid in insertion, placement, fixation, and anchoring of mesh in the body. The FDA proposal provides that such instruments provided in kits will also be reviewed as part of the regulatory submission for a mesh product.

The FDA has previously (in 2012) issued orders requiring manufacturers of urogynecologic surgical mesh devices to conduct postmarket surveillance studies to address specific safety and effectiveness concerns related to surgical mesh used for transvaginal repair of POP. Consistent with its usual procedures, The FDA will take comments on the recently-announced proposal for 90 days.

Heygood, Orr & Pearson and Surgical Mesh Cases

If you or a loved one were injured by a surgical mesh product, you may be eligible to file a lawsuit and receive a settlement from the company that manufactured the device. The lawyers at Heygood, Orr & Pearson have represented hundreds of individuals who have been injured by dangerous medical devices like surgical mesh. Our law firm has won hundreds of millions of dollars in verdicts and settlements on behalf of our clients, and will work to ensure that you receive the compensation for your injuries that you are entitled to under the law

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Heygood, Orr & Pearson has the resources and experience to protect your rights against irresponsible pharmaceutical companies and medical device manufacturers. If you have been injured or have lost someone you care about because of defective or dangerous prescription drugs or medical devices, you deserve to have the manufacturer held responsible for such and deserve proper compensation. Contact us by calling toll-free at 1-877-446-9001 or by filling out our case evaluation form to find out more about your legal options.