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Vaginal Mesh Now Deemed “High Risk”, What This Means

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In light of a significant increase in adverse event reports associated with vaginal mesh devices, the FDA has reclassified the product as a high-risk device. Transvaginal mesh is used in the treatment of pelvic organ prolapse (POP) and stress urinary incontinence (SUI), as well as for abdominal repair of POP. The high-risk classification only applies to mesh used in transvaginal POP repair.

Pelvic organ prolapse occurs when weak abdominal tissues can no longer support abdominal organs. The condition can be extremely painful and can result in organs protruding outside of the vaginal opening. Older women are most at risk of developing POP. In the past, surgical procedures were conducted through the abdomen, but transvaginal mesh claimed to involve a less invasive, less painful procedure with a shorter recovery time. Unfortunately, hundreds of women have been seriously injured by these devices. There are currently multiple lawsuits pending against several surgical mesh manufacturers, including American Medical Systems, C.R. Bard, Cook Medical, and Boston Scientific.

Transvaginal Mesh Linked to Persistent Pain and Infection

On January 4, the FDA published a press release announcing its new classification for vaginal mesh devices. In addition, the agency is requiring manufacturers to prove the safety and efficacy of their product. These updates are in response to years of injuries linked to surgical mesh devices. The FDA updates have changed the classification of transvaginal mesh devices from a class II to a class III, which is given to devices that carry a high risk. Severe and persistent pain and painful intercourse are among the common risks associated with surgical mesh. However, one of the most dangerous risks is mesh erosion, which can result in potentially life-threatening infections.

Beyond the new warnings, surgical mesh manufacturers will now be required to prove that their product is safe and effective by submitting a premarket approval (PMA) application. In the past, manufacturers were able to utilize the FDA’s 510(k) process, which provides an easier route to approval for low-risk medical devices similar to those already on the market. In doing so, they were able to bypass clinical trials. Had clinical trials been required to obtain FDA approval, countless injuries may have been prevented. The PMA process will apply to all existing manufacturers, as well as to new manufacturers and devices entering the market. The following quote from the chief scientist for the FDA’s Center for Devices and Radiological Health, William Maisel, MD, MPH, appeared on the agency’s website: “These stronger requirements will help to address the significant risks associated with surgical mesh for repair of pelvic organ prolapse.”

The Goldwater Law Firm – Medical Device Injury Lawyers

More than $5.5 million has been awarded to people injured by vaginal mesh injuries and that number is expected to rise sharply. If you have been injured due to a transvaginal mesh device, it is in your best interest to contact the Goldwater Law Firm immediately. Our skilled team of injury lawyers will help you determine your rights and options before moving forward. You may be entitled to compensation for medical bills, pain and suffering, and other associated costs. Contact the Goldwater Law Firm today for a free consultation.