FDA proposed orders reclassifying transvaginal mesh as a high-risk device

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Recently two final orders have been issued by the U.S Food and Drug Administration to manufacturers and the public, the first one is to reclassify these medical devices from class II, which generally includes moderate-risk devices, to class III, which generally includes high-risk devices, and a second order that requires manufacturers to submit a premarket approval (PMA) application to support the safety and effectiveness of surgical mesh for the transvaginal repair of POP. FDA orders manufacturers and the public to stronger the clinical requirements will help to address the significant risks associated with surgical mesh for repair of pelvic organ prolapse. To warn doctors and patients about the use of surgical mesh for transvaginal POP repair, the FDA has issued safety communications in 2008 and in 2011 warning doctors and consumers about an increase in adverse event reports related to mesh used for urogynecological procedures.


Transvaginal mesh, also called vaginal mesh or surgical mesh, has been used in the medical field since the 1950s, when it was introduced as a means of repairing abdominal hernias, and in the 1990s, surgeons began implanting mesh for the transvaginal repair of pelvic organ prolapse (POP). In 2002, transvaginal mesh was cleared for use as a class II moderate-risk device. Surgical mesh is a medical device that is used to provide additional support when repairing weakened or damaged tissue. Many mesh products come in kits that include instruments specifically designed to aid in insertion, placement, fixation, and anchoring of mesh in the body. Instruments provided in kits will be reviewed as part of the regulatory submission for the mesh product. Instruments are also provided separately from the mesh implant, and the FDA is proposing that this urogynecologic surgical instrumentation be reclassified from low-risk devices (class I) to moderate-risk devices (class II).


The Food and Drug Administration decision to reclassify vaginal mesh was on large number of complaints about the mesh, multiple lawsuits have been filed against one of the most well known vaginal mesh manufacturers Johnson & Johnson. Vaginal mesh has been linked to severe complications. Commonly reported problems include severe pelvic pain, pain during intercourse, infection, internal bleeding, organ perforation and urinary problems from mesh eroding into surrounding tissues.The decision by the FDA to reclassify the transvaginal mesh products as “high risk products” is a confirmation of the inherent danger of these products. Countless women have suffered from pain during intercourse, pelvic pain, recurrent infections, mesh erosion, mesh extrusion and several surgeries to remove the mesh.

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