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UPDATE – FDA Warning: Serious Complications Associated with Transvaginal Placement of Surgical Mesh for Pelvic Organ Prolapse

Transvaginal mesh implants have been used to treat pelvic organ prolapse “POP” and stress urinary incontinence. In 2010, almost 300,000 women received mesh implants. However, in July 2011, the FDA issued a public safety warning about these products. The warning states that studies show 10 percent of women who underwent transvaginal mesh surgery to correct vaginal prolapse experienced severe complications within the first year post surgery. The mesh can erode into the vaginal walls or other organs within a year after surgery. It may tighten or shift, causing it to protrude into the vaginal canal. The experiences of the women who have been the victims of these products have ranged from serious to horrific, with some women experiencing constant and unremitting pain and discomfort!
The complications of transvaginal mesh are completely out of character with the products’ original marketing, which touted them as low-risk procedures. The reality is that the problems and post surgical complications associated with mesh products can be literally life-changing. In its typical understatement, the FDA has written “it is not clear that transvaginal POP repair with mesh is more effective than traditional non-mesh repair in all patients with POP,” and that the treatment may expose patients to greater risk than the original condition.
Injured women may experience:

  • Erosion, and possible exposure or extrusion, of mesh through vaginal tissue
  • Perforation of pelvic organs, bowels and blood vessels
  • Pelvic pain and difficulty moving
  • Abdominal pressure
  • Recurrence of POP
  • Vaginal discharge and infections
  • Vaginal bleeding
  • Vagina scarring or shortening
  • Urinary incontinence

Women experiencing these injuries can have trouble with many types of activities including sitting, walking and having sexual intercourse. To correct the injuries caused by transvaginal mesh, women may be forced to endure multiple surgeries, often with only limited success. Often times the victims of mesh products face a lifetime of chronic pain and disability.
Several companies manufacture surgical transvaginal mesh products:

  • American Medical Systems
  • Boston Scientific
  • C.R. Bard, Inc.
  • Caldera Medical
  • Johnson & Johnson/Ethicon – Johnson & Johnson has now recalled four of its mesh products. The company sent a letter to the FDA and judges overseeing mesh lawsuits in New Jersey and West Virginia. The letter stated the company would no longer sell the Gynecare TVT Secur system, Gynecare Prosima, Gynecare
  • Prolift and Gynecare Prolift + M products.

5/17/12 FDA Policy Update on Surgical Mesh Implants
7/13/11 FDA Safety Communication: UPDATE on Serious Complications Associated with Transvaginal Placement of Surgical Mesh for Pelvic Organ Prolapse
Terrell • Hogan’s Original Alert August 4, 2011:  The Food and Drug Administration is warning doctors and patients that using a mesh product in vaginal repair surgery can lead to serious complications. The FDA’s deputy director, Dr. William Maisel, said there are “clear risks” associated with the mesh. “The FDA is asking surgeons to carefully consider all other treatment options and to make sure that their patients are fully informed about potential complications. The mesh is used to support sagging pelvic organs such as the bladder, uterus, and bowel after they have been lifted back out of the vagina, where they descended.
Mesh-related problems reported to the FDA include painful sexual intercourse, infections, urinary problems, overall discomfort, and bleeding, usually from the mesh eroding through the stitched tissue or from skin contracting tightly around it.
The FDA has decided that it is not necessary to remove the products from the market, Dr. Maisel said “However we think it is important that patients and health care providers have the information we have about the adverse events.  Patient advocates disagree and say the FDA has not gone far enough.
Click here for the FDA Safety Alert


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About The Author

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Laura Hack

Laura Hack is a paralegal with Terrell • Hogan. She has been with the firm since 1996 and has worked primarily for Wayne Hogan. She is an experienced Paralegal with 30+ years of working in the law practice industry. Skilled in Appeals, Civil Trial Litigation Support, Torts, Trial Practice, and Pleadings.