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Oct 15, 2009 (Ft. Lauderdale, Florida)

An article published on MedPageToday.com, FDA Warn of Transvaginal Mesh Procedure Complications, seems to indicate that the USFDA does not go far enough to warn of the risks and hazards associated with the use of transvaginal meshes in the treatment of severe urinary incontinence (UI). Based upon the studies now conducted by several significant authorities on the long term efficacy of all of the severe UI treatments, including the transvaginal meshes (i.e.; Guideline No.35 from the Royal College of Obstetricians and Gynaecologists, etc.), the efficacy rates of these procedures, as a whole, are tabulated as low as 45%, while the “sling removal” rates were reported as high as 35% in some of the summary reports.

Given the number of sling surgeries in the US alone (probably upwards of 125,000 procedures per year), and the number of reported serious complications within a number of the case studies (as high as 35%), it would seem that the reports citing serious complications in the USFDA release were significantly underreported.

The list of cautions that the USFDA recommended in the article should be a standard part of every pre-surgical patient conference, including:

  • Obtain specialized training for each mesh placement technique, and be aware of its risks.
  • Be vigilant for potential adverse events from the mesh, especially erosion and infection.
  • Watch for complications associated with the tools used in transvaginal placement, especially bowel, bladder, and blood vessel perforations.
  • Inform patients that implantation of surgical mesh is permanent, and that some complications may require additional surgery to correct the problem.
  • Inform patients about the potential for serious complications and their effect on quality of life, including pain during sexual intercourse, scarring, and narrowing of the vaginal wall.
  • Provide patients with a written copy of the patient labeling from the surgical mesh manufacturer, if available.

The FDA also recommended that patients let their surgeon know if they’ve had a past reaction to mesh materials such as polypropylene.

In contrast, our Company (Precision Medical Devices, Inc. – PMD) is about to introduce a new device product (a remote-telemetry-controlled bionic ADJUSTABLE urethra valve implant called the flow-control device – FCD) that is expected to be the first treatment product to revolutionize the treatment of severe UI in the last 30 years. The product is expected to have a very low risk profile with comparatively few adverse events versus all of the other currently in-use severe UI treatments (as all of the FCD product’s component implant pieces are made from materials that have be found to be safe and inert in implants of other products for over 30 years).