FDA Strengthens Safety Requirements for Transvaginal Mesh Products
The U.S. Food and Drug Administration (“FDA”) has issued tighter regulations for surgical transvaginal mesh products that are designed to address pelvic organ prolapse, which is a condition that occurs when the pelvic floor is no longer able to support a woman’s pelvic organs. The surgical mesh is intended to strengthen the pelvic floor and wall, and to help keep the pelvic organs in place. The devices have been used for several decades in surgeries to treat pelvic organ prolapse and the stress urinary incontinence that results from the condition.
Common issues associated with the devices surfaced around 2002, involving devices implanted through the vaginal canal as opposed to through the abdomen. The method of implantation through the vaginal wall was touted as a more efficient way to implant the device that required less healing time and resulted in a smaller incision. According to the FDA, however, the veracity of these claims has not been proven.
After surgery, many women reported experiencing pain, organ perforations, infection, bleeding, urinary issues, and other problems, due to the mesh migrating after implantation. In many cases, this required additional surgeries to replace or remove the device.
Now, after tens of thousands of lawsuits have been filed against a number of device manufacturers like Bard, Johnson & Johnson, Boston Scientific, and others, the FDA has determined that the use of transvaginal mesh to address pelvic organ prolapse poses more substantial risks for women than the use of mesh products in traditional abdominal repair procedures. As a result, the FDA has reclassified vaginal mesh products from Class II devices, which pose a “moderate risk,” to Class III devices, which pose a “high risk.” Class III devices receive the utmost scrutiny from the FDA when it comes to reviewing the risks they pose and how they are used in surgical settings.
As part of the FDA’s new approach to transvaginal mesh, product makers must now provide a premarket approval application describing the efficacy and safety of their products and making specific mention of the injuries that women have commonly reported after receiving the devices, including organ perforation and pain. Existing device makers have 30 days to provide their applications, and new device manufacturers must submit this information along with their initial request for the FDA’s approval of the device. It should be noted that these new requirements only apply to mesh products used for treating pelvic organ prolapse, not mesh products used for treating abdominal conditions.
If you or someone you love has suffered injuries after receiving a transvaginal mesh product, you may be entitled to compensation. The seasoned and dedicated medical device lawyers at Moll Law Group have counseled accident victims across the nation, including in California, New York, and Illinois. We offer a free consultation to help you learn about your options, so call us at 312-462-1700 or contact us online to set up your appointment.
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