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FDA Proposes Stricter Safety Requirements for Pelvic Mesh

By: Allan M. Siegel

In recent years, pelvic mesh products have been found to pose significant risks to patients who have had them implanted. This includes transvaginal mesh and hernia mesh. In response to reports of adverse side effects experienced by patients, the U.S. Food and Drug Administration (FDA) issued official warnings about pelvic mesh in 2008 and 2011. Just last month, the FDA proposed new rules to more strictly regulate these products.

According to a federal proposal made on April 29, 2014, pelvic mesh implants pose substantial dangers and should be reclassified as a high risk medical device. The FDA's proposal would require manufacturers to prove that their products and implants are safe for patient use before they are put on the market.

Pelvic Mesh Lawsuit

The FDA states that this push for tighter regulations is in response to years of patients reporting adverse side effects, including:

  • Bleeding
  • Infection
  • Organ perforation
  • Mesh erosion
  • Pain and scarring

The new proposed rules come three years after the agency discovered that women who receive mesh implants experience more complications than those treated with traditional surgery and stitches. One FDA study found that 10% of women experienced transvaginal mesh erosion within one year, and that half of the women required correctional surgeries to remove the mesh – some even required two or three surgeries.

Fortunately for the many patients who have suffered harm as a result of these unsafe products, the FDA is now cracking down. Unfortunately, damage has already been done and many patients have already suffered harm because product manufacturers – including Johnson & Johnson – made these unsafe implants available. Johnson & Johnson is currently facing more than 20,000 lawsuits from victims injured by pelvic mesh.

Chaikin, Sherman, Cammarata & Siegel, P.C. is currently reviewing cases of patients who have suffered harm after having pelvic mesh implanted. If you would like to learn more about your rights and how a Washington, DC personal injury attorney from our firm can help you file a lawsuit, call 202-644-8303 or fill out a free case evaluation form today. We represent clients throughout the DC metro area from offices in Northern Virginia, Maryland, and Washington, DC.