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Andrew D'Arcy
Andrew D'Arcy
Attorney • (609) 641-6200

Transvaginal Mesh & the FDA – What you Need to Know

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Transvaginal Mesh is a surgical device that recently has come under much scrutiny due to FDA reports linking it to thousands of injuries as well as deaths. The device is surgically implanted within a woman’s uterus to support weak pelvic muscles, and is used to treat conditions such as pelvic organ prolapse (POP) or stress urinary incontinence. The device is sometimes referred to as a bladder sling due to the nature of its implantation and it is generally made from polyester or polypropylene. There are several manufacturers of the mesh, including large corporations such as Johnson & Johnson, and Endo Pharmaceuticals. Nearly 75,000 women had the mesh surgically implanted in 2010. But the increase in women receiving the device comes on the heels of FDA controversy that could soon lead to stricter regulations on the manufacturers, or even a recall on all products. All for good reason though; the complications that have been tied to the transvaginal mesh are quite serious, and according to the FDA studies performed in 2008, included:

  • Erosions through the vaginal epithelium
  • Infection
  • Constant Severe Pain
  • Urinary problems
  • Recurrence of Prolapse and/or incontinence
  • Bleeding

The conclusions were also backed by a 2010 study performed by the Journal of Obstetrics and Gynecology. The controlled trial took 65 women who had undergone surgery for either incontinence or prolapse conditions, 32 of which had used the transvaginal mesh as a corrective surgery. The trial, however, came to a screeching halt when it was found the 15.6% of the participants were suffering vaginal erosion due to the surgical mesh implants. The New England Journal of Medicine performed a similar study comparing the traditional treatment of POP and incontinence to transvaginal mesh implants and the statistics were startling. It was found the mesh had a much higher risk of defect including:

  • 7 times the risk of bladder perforation
  • 2 times the risk of urinary incontinence
  • And 3.2% of women who received the mesh needed surgery to correct problems caused by it

Transvaginal Mesh originally passed FDA inspection through their 510(k) process by which manufacturers of the device are cleared through the regulation process without clinical trial because their product is “substantially equivalent” to one that already exists on the market. In light of the recent dangers brought to light, consumer advocacy groups have pushed for the product to be recalled immediately and asked for all similar products being brought to market be classified by the FDA as a Class III device, which would call for rigorous clinical trials before being introduced to the public. Between January 2008 and December 2010, there have been 1503 cases of women that suffered adverse effects following POP surgery using the mesh and according to Public Health Information, complications with surgical mesh are “not rare”.

As it stands today, there has been no recall or re-classification of these devices despite the mounting evidence against them. Gynecologists and Obstetricians have been warned to use the surgical mesh as a last measure procedure, but without stricter FDA regulations, manufacturers will continue to market this device without having to fully disclose all of the complications that may come with it.