Vaginal Mesh Problems Lead FDA to Consider Stricter Mesh Regulations

As explained in an official document released recently, the U.S. Food and Drug Administration (FDA) is considering tightening regulations on the use of vaginal mesh surgical products in the treatment of pelvic organ prolapse (POP), citing the alleged high risk of negative complications from the devices. Transvaginal mesh is used in a procedure where mesh is inserted into the vagina to treat POP or stress urinary incontinence (SUI). The FDA will convene the Obstetrics & Gynecology Devices Advisory Committee to discuss the use of surgical mesh for treatment of certain vaginal problems and will consider their options moving forward. According to the Wall Street Journal, out of 75,000 procedures where mesh was used, the FDA received reports of over 1500 complications just between the years of 2008 and 2010.

Out of 75,000 procedures where mesh was used, the FDA received reports of over 1500 complications just between the years of 2008 and 2010.

Mesh is surgically inserted into the vagina most commonly to treat POP, which occurs when the structures that hold the pelvic organs become so weak or stretched that the organs move from their original position and prolapsed into the vagina. Once the mesh is inserted though, it can reportedly contract and the complications of this can be comparable to those of the original condition. The alleged adverse physical effects due to the contraction of the mesh are varied, including vaginal shortening, bleeding, scarring, infection, mesh erosion, perforation, tightening and significant pain. In addition to possible adverse effects of the device, the FDA concluded that through preliminary investigations that there is not conclusive evidence that the use of transvaginal mesh to repair POP is a more successful method than alternative non-mesh procedures. For this reason, the FDA is currently advising that if possible, individuals and healthcare professionals should instead seek traditional solutions until the effects of transvaginal mesh can definitively be flushed out.

Referenced in the conclusion section of the document released by the FDA, the regulations that the organization is considering changing are: 1) A change in risk classification of mesh used for transvaginal POP repair from Class II to Class III, which would require manufacturers to submit premarket approval applications, including relevant clinical data for these device, 2) Clinical studies to address the risks and benefits of mesh used to treat POP and SUI and 3) Expanded post-market monitoring of device performance.

Transvaginal mesh side effects are serious, and victims may experience serious physical, emotional and financial hardships as a result of this surgical procedure. More than a handful of companies manufacture transvaginal mesh, including Boston Scientific Corp. (BSX) and Johnson & Johnson (JNJ), of which many have been the subject of vaginal mesh lawsuits alleging that they knowingly manufactured and marketed dangerous products. If you or a loved one has experienced POP mesh complications, contact a dedicated vaginal mesh attorney by completing the free, no obligation form on the right to find out if you can seek compensation for your pain and suffering, lost wages and medical bills.