FDA Warns of Complications Caused by Surgical Mesh in Transvaginal Repair
Thousands of women who received surgical mesh in a transvaginal repair procedure to correct pelvic organ prolapse face a series of complications and risks, according to the latest findings of the Food and Drug Administration (FDA).In a two-year period from 2008 to 2010 the FDA said it received 1,503 adverse-event reports triggered by the use of the mesh in pelvic organ prolapse repairs, or POP repairs. The corrective surgery is often performed through the vagina, or transvaginally, using a combination of the mesh and stiches to reinforce the anatomical repair.“The FDA is asking surgeons to carefully consider all other treatment options and to make sure that their patients are informed of potential complications from the surgical mesh,” FDA Dr. William Maisel said in a written statement.Maisel further warned that the surgical mesh is a ”permanent implant. which means that complete removal may not be possible and may not result in complete resolution of complications.”Known Surgical Mesh Complications In addition to this stern warning, the FDA listed a host of Mesh complications associated with the surgical mesh that could affect the 75,000 patients who underwent the transvaginal repair in 2010.The complications include:
- Mesh exposed or protruding from vaginal tissue.
- Pain during sexual intercourse
- Urinary problems
- The perforation of other organs caused from surgical tools used in placing the mesh
- Additional surgeries needed to repair or treat complications caused by the mesh
Studies Back FDA’s Conclusions Other leading studies confirm the FDA’s conclusions on the complications caused by implanted surgical mesh used in transvaginal repair for POP.In fact, a research paper published in the medical journal Obstetrics & Gynecology in 2010 found an alarmingly high 15.6 percent erosion rate of implanted surgical mesh only three months after a patient received the procedure.Even more disturbing is a study published in the New England Journal of Medicine in 2011, which found that despite the surgical mesh used in transvaginal repair sometimes curing the symptoms of POP, the risks and complications outweighed the benefits in many ways.Here are just some of them:
- Patients receiving the surgical mesh had nearly twice as much chance of developing urinary incontinence.
- Those receiving the mesh had seven times the risk of bladder perforation than colporrhaphy
- .More than 3 percent of those women who had the surgical mesh implanted during a transvaginal repair required additional surgery to correct problems caused by the mesh.
Consumer Group Calls for Recall The numerous complications occurring as a result of the surgical mesh has prompted grassroots consumer advocate organizations like Public Citizen to ask the FDA to immediately ban its marketing and use for transvaginal repair.While a growing number of patients who have fallen victim to the complications triggered by the mesh have been filing a surgical mesh lawsuit against its various manufacturers, there has been no class-action lawsuit as of yet. The makers of the mesh include Johnson & Johnson, C. R. Bard, Boston Scientific Products and American Medical Systems.If you or one of your loved ones are or have suffered any of the described complications associated with surgical mesh used in a transvaginal repair, please contact us. Make sure you get the representation and compensation for which you or your loved ones are entitled.
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