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No Vaginal Mesh Recall from FDA Yet

No Vaginal Mesh Recall from FDA Yet

August 6, 2012 — The U.S. Food and Drug Administration (FDA) has not issued a vaginal mesh recall, despite the fact that the FDA has received approximately 4,000 reports of serious vaginal mesh injuries. Instead of recalling vaginal mesh, the FDA has published two safety warnings — one in 2008, and another in 2011 after they continued to receive thousands of injury reports. A few months after the FDA asked dozens of manufacturers to conduct safety studies, C.R. Bard stopped selling the Avaulta vaginal mesh, and Johnson & Johnson stopped selling all four of its vaginal mesh products. However, these companies did not recall their device.

One surgical mesh device that was recalled is the ProteGen, manufactured by Boston Scientific Corp. When the FDA approved the ProteGen in the 1990s, it was the first vaginal mesh to win approval for the treatment of Stress Urinary Incontinence (SUI). The approval of the ProteGen was quickly followed by Johnson & Johnson’s Gynecare TVT vaginal mesh, which was approved under the 510(k) process.

The 510(k) approval process allows new devices that are “substantially equivalent” to existing, approved devices to avoid conducting expensive, time-consuming clinical studies. So long as a manufacturer claims their device is “similar,” they can gain FDA approval without submitting safety studies.

Unfortunately, Boston Scientific began receiving an alarming number of adverse event reports related to the ProteGen — including erosion, pelvic pain during intercourse, infection, and nerve damage. Boston Scientific voluntarily recalled the ProteGen in 1999.

However, other devices that were approved under the 510(k) process were not recalled, nor did the FDA require them to conduct safety studies at that time. The FDA continued to approve vaginal mesh devices that were based on the recalled vaginal mesh from Boston Scientific.

In August 2011, the consumer advocacy group Public Citizen petitioned the FDA to ban all marketing of vaginal mesh, order manufacturers to recall the products, and require that any vaginal mesh devices introduced in the future must conduct a well-designed clinical study proving the device is safe and effective. Public Citizen was concerned that vaginal mesh was linked to a higher risk of side effects but was no more effective than existing surgical methods for treating SUI or Pelvic Organ Prolapse (POP).

Instead of waiting for the FDA to issue a vaginal mesh recall, many women are contacting a lawyer to file a vaginal mesh lawsuit. In the first-ever vaginal mesh lawsuit, Christine Scott was awarded $5.5 million for her vaginal mesh injuries. Scott says she plans to use to money to create a website and form a support group for other women who have been seriously injured by vaginal mesh.

At least 650 vaginal mesh lawsuits are currently pending in federal court, and women continue to contact The Schmidt Firm, PLLC for information on how to join the ongoing litigation. If you were injured by vaginal mesh, you could have a vaginal mesh lawsuit and be entitled to significant financial compensation.

Do I have a Vaginal Mesh Lawsuit?

The Schmidt Firm, PLLC is currently accepting vaginal mesh induced injury cases in all 50 states. If you or somebody you know has been injured by vaginal mesh, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Vaginal Mesh Litigation Group or call toll free 24 hours a day at (866) 920-0753.

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