Which Implant Do You Have?
Please Check the Box Below

Johnson and Johnson

Mentor Corporation

Sofradim

Other/Not Sure

What Problems are
you Experiencing?

Mesh Erosion

Scar tissue formation

Dysuria (painful urination)

Dyspareunia (painful sexual relations)

Other

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FAQ

  1. What is transvaginal mesh?
    • TVM is woven mesh implants that stretch across the vaginal wall to support damaged tissue or prolapsed organs.  TVM has many holes within it to allow the body’s own tissue to grow into the mesh which is supposed to help support internal organs that were once supported by the vaginal wall until a significant stretching, such as during childbirth, may have damaged the tissue.
  2. What kind of material do companies make TVM from?
    • Surgical mesh currently is produced by several different manufacturers and is available in non-absorbable polyester, absorbable synthetics, animal tissues, and combinations of these materials. TVM is a permanent synthetic material, typically, made of woven mesh fibers.
  3. What are the various names of TVM?
    • Transvaginal mesh is commonly referred to as pelvic mesh, vaginal mesh, bladder slings, transvaginal mesh patches or surgical mesh.
  4. What are the complications with TVM?
    • These implants have led to serious complications such as mesh erosion, infection, pain, bleeding, recurrence of prolapse, urinary problems and bowel, bladder and blood-vessel perforations.  TVM has led to other problems that led to a significant decrease in quality of life due to discomfort and pain.  Often, women experiencing complications from TVM require additional surgeries to remove mesh because of vaginal erosion.
  5. What should I do if I have TVM?
    • Consult your doctor immediately to be examined to determine if the pelvic mesh has failed and if you will be required to undergo revision surgery.  Be sure to find out the manufacturer and the type of TVM implanted.
  6. What are alternatives to having TVM implanted to treat pelvic organ prolapse (POP)?
    • There are a few viable alternatives for treating pelvic organ prolapse without using TVM.  The standard procedure for repairing a pelvic organ prolapse is stitching together the area of connective tissue (fascia) where there is a weakness. This treatment is called anterior colporrhaphy.  Another alternative to the transvaginal mesh surgery is the vaginal pessary for prolapse procedure which involves the installation of a pessary device which supports the vagina. As an alternative to vaginal prolapse surgery the pessaries have proven successful, though the pessaries require replacing every 3 to 6 months.
  7. How many complications and adverse event reports have been given to the FDA?
    • Since 2005, the FDA has received over 4,000 adverse event reports pertaining to pelvic mesh.  An FDA review of adverse events of all urogynecologic surgical mesh products from January 2005 to December 2010 identified 3979 reports of injury, death, and malfunction. Among the reports, 2874 were received in the last 3 years (January 1, 2008, to December 31, 2010), and included 1503 reports associated with POP repairs and 1371 associated with SUI repairs. The number of reports associated with POP repairs increased by more than 5-fold compared with the number of reports received in the previous 3 years (January 1, 2005, to December 31, 2007), according to the FDA. Between 2008 and 2010, 7 reported deaths were associated with POP repairs. Follow-up investigation revealed that 3 of the deaths were related to the mesh placement procedure (2 bowel perforations, 1 hemorrhage).
  8. Which companies have the majority of complications, side effects or adverse events reported to the FDA?
    • The FDA indicates that Boston Scientific, Johnson & Johnson, American Medical Systems, Cook, Covidien, and C.R. Bard’s products have caused the vast majority of adverse events.
  9. How do I report my complications with TVM to the FDA?
    • It is important that patients report complications that may be associated with these products.  You can report any problems to the FDA's MedWatch Adverse Event Reporting program either online, by mail or FAX.

    Online: MedWatch Online Voluntary Reporting Form (3500)
    Mail: use postage-paid FDA form 3500 available at: MedWatch Forms
    Mail to MedWatch 5600 Fishers Lane, Rockville, MD 20852-9787
    FAX: 1-800-FDA-0178

  10. Are there any companies to be more worries about?
    • The FDA adverse event reports have not been linked to a single brand or model of mesh.