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FDA Requires Emergency Safety Study of Vaginal Mesh

FDA Requires Emergency Safety Study of Vaginal Mesh

January 5, 2012 — The Food and Drug Administration (FDA) is requiring emergency safety studies of vaginal mesh, surgical mesh, and transvaginal mesh. The FDA is forcing the companies who make these medical devices to study the risks, after years of reports that they can cause serious complications, including death. An FDA advisory panel recommended in September that companies be required to conduct the safety studies, after there was a five-fold increase in adverse event reports between 2008 and 2010. 

Vaginal mesh belongs to a class of implantable medical devices that manufacturers do not have to study before they are marketed to consumers, under the FDA’s 510(k) system, which allows products to reach the market without human testing if there are similar devices already for sale. Additionally, manufacturers also do not need to study patients after they receive the implanted devices.

In 2010, around 185,000 women had surgery to implant vaginal mesh. Of those, an estimated 15% had complications, according to the journal Obstetrics and Gynecology. Complications include organ damage. The study in the journal concluded that vaginal mesh was no more effective than traditional surgical techniques, in which doctors use a patient’s own tissue to strengthen the wall and support internal organs.

The FDA has been aware of problems with vaginal mesh for several years. In 2008, the association issued a safety warning to consumers announcing reports of serious complications, but said that the reports were uncommon. From 2008 to 2010, however, there was five-fold increase in adverse event reports.

The FDA-mandated emergency safety studies will likely take several years to complete. The companies will need to design a study that meets the FDA standards, and then track women who have received the surgical mesh over three years. The FDA sent letters to Johnson & Johnson, C.R. Bard Inc., and 31 other manufacturers of these devices. These manufacturers are now facing more than 650 vaginal mesh lawsuits from consumers who experienced death, injuries, or malfunction with the products.

How do I contact a Lawyer for 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 experienced a side effect cause by vaginal mesh, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Vaginal Mesh Lawsuit Group or call toll free 24 hours a day at (866) 920-0753.

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