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TRANSVAGINAL MESH AND BLADDER SLINGS: FDA WARNS OF SERIOUS COMPLICATIONS

On July 13, 2011, the Food and Drug Administration issued a public health warning on complications associated with transvaginal mesh placement of surgical mesh for pelvic organ prolapsed (POP) and stress urinary incontinence (SUI). The FDA issued a strongly worded report warning that: (i) Complications related to transvaginal mesh surgery are occurring at a significantly high rate; (ii) There is no evidence that transvaginal mesh repair is more effective than traditional non mesh repair or that it provides any added benefit; and (iii) Transvaginal mesh surgery exposes patients to greater risk than traditional non mesh repair. This is a change from what previous FDA reports. The update states that surgical mesh for TVM repair of POP is an area of “continuing serious concern.”

TRANSVAGINAL MESH/BLADDER SLINGS: WHAT ARE THEY AND WHAT ARE THEY USED FOR?

Transvaginal mesh (TVM) and sling devices are medical devices surgically implanted to repair and reinforce weakened or damaged vaginal tissue, and to treat pelvic organ prolapse (POP) and stress urinary continence (SUI). Surgical repair of SUI can be performed through a vaginal incision by placing a biologic or synthetic “sling” (e.g., surgical mesh) under the urethra to help prevent urinary loss during physical activity. Surgeons also use surgical mesh to augment transvaginal POP repairs. The placement of surgical mesh is intended to increase the longevity of POP repairs. The mesh devices are typically placed transvaginally but may also be placed through an incision in the abdomen.

Other FDA statements and findings released in the July 2011 update include:

  • 50% of women who have surgery to remove the TVM continue to have complications and side effects because the mesh is often completely absorbed making the mesh impossible to remove
  • Adverse effects continue despite removal of the mesh
  • As much as 10% of the mesh may erode within 12 months of surgery
  • Incontinence after TVM surgery is more recurrent than with traditional methods
  • There is a higher incidence of second surgery following a surgery to implant TVM than any other vaginal surgery
  • Complications associated with TVM are not experienced among patients who have traditional surgery

COMPLICATIONS AND SIDE EFFECTS – ARE YOU HAVING THESE SYMPTOMS?

Complications include: recurrent urinary tract infections, yeast infections, Pudendal Neuralgia (including nerve damage and/or pain that radiates from the pelvis down the front of the legs), pelvic, abdominal and/or lower back pain, difficulty urinating, pain/burning with urination, issues with bowel movements, granulation tissue, abscesses, spotting, urinary leakage, bowel or bladder dysfunction, vaginal scarring, severe physical pain and altered pelvic anatomy, pain with intercourse, bleeding from mesh site, damage to nearby organs, urinary tract problems, recurrence of POP or SUI, mesh erosion into the vagina, bladder, intestines, and uterus, mesh shrinkage or contraction, mesh migration and mesh exposure. 

If you are having these symptoms, then you may also have the following, as a result of this defective mesh:

repeat surgery(s) to have the mesh repaired or removed, blood transfusions, IV therapy, drainage of hematomas and a significant decrease in the quality of life.

LEGAL RIGHTS OF THE INJURED

If you or a loved one has under gone a surgical procedure to treat POP or SUI and have suffered complications as a result of a transvaginal mesh or bladder sling implant, you may be entitled to legal compensation from the manufacturers of these defective products.

The lawyers of the firm Taylor Martino are ready to evaluate your claim and assist you in seeking compensation for your pain, suffering, and other physical injuries, the cost of restorative surgery as well as other financial difficulties, resulting from injuries caused by these defective products. Please call us for a free consultation and case evaluation.

HISTORY AND HOW THE MESH PRODUCTS GAINED FDA APPROVAL

The FDA’s oversight of medical devices has been called into question by auditors with the U.S. General Accounting Office. In 2009, federal auditors listed the FDA’s oversight of medical devices as a high-risk area warranting the attention of Congress.

The transvaginal mesh products received expedited approval from the FDA through a legal process called the 510(k) process. Considered by many to be a legal loophole, the FDA’s 510(k) process allows a manufacturer to certify that its product is substantially equivalent to another legally marketed product, avoiding the long pre-market approval process. Manufacturers of vaginal mesh products who take this route, avoid having to demonstrate the safety of their vaginal mesh products through clinical trials prior to their release on the market.

TRANSVAGINAL MESH MANUFACTURERS AND PRODUCTS

  • Johnson & Johnson (Ethicon): Prolene Mesh/Prolene Soft Mesh, Gynemesh, TVT, TVT-O, TVT-Secur, TVT Exact, TVT Abbrevo, Prolift, Prolift +M
  • American Medical Systems: Apogee, Perigee, SPARC, Mini-Arc Single Incision Sling, Mini-Arc Precise Sling, Monarc Subfascial Hammock, Elevate with IntePro Lite, In-Fast Ultra with IntePro Lite/Synthetic Mesh, BioArc SP, MiniArc Sling System, Lite Pelvic Floor Repair Kit
  • Boston Scientific: Pinnacle, Advantage, Obtryx, Lynx, Prefyx, Solyx, Posterior Uphold
  • Bard: Align, Avaulta Biosynthetic Support Systems, Avaulta Solo, Avaulta Plus Support Systems, Pelvicol, PelviLace, PelviSoft, Pelvitex, Ugytex, Uretex
  • Coloplast (includes Mentor’s mesh brands): ARIS TOT, NovaSilk
  • Caldera Medical: T-Sling, Desara
  • Cook Medical: Stratasis
  • Tyco Healthcare: IVS

To determine the manufacturer and type of transvaginal mesh you have, contact the hospital or physician’s office where your procedure was performed. The name of the mesh, catalog number, lot number and size should be recorded in your medical records.

Related Articles:

http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm262435.htm

http://www.fda.gov/downloads/MedicalDevices/Safety/AlertsandNotices/UCM262760.pdf

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