Trans-vaginal Mesh Makers ordered by FDA to Study Risks
The Food and Drug Administration has ordered medical device manufacturers to study safety complications with trans-vaginal mesh used in women's pelvic surgeries. In April an FDA report found that women who have the surgical mesh implanted are at greater risk of pain , bleeding and infection than women who have traditional surgery with stitches.
For more information visit the FDA website at:
Surgeons have been successfully employing mesh fabricated from polypropylene for hernia repairs for decades. In the late 1990's, manufacturers sought new surgical uses for this material in order to expand their markets and determined that due to the large number of pelvic surgeries being performed on women for stress urinary incontinence (SUI) and pelvic organ prolapse (POP) polypropylene mesh “slings” could be marketed with very profitable returns. SUI and POP are relatively common conditions that occur in women who have given birth, usually multiple times, due to the stress labor and delivery creates on the pelvic musculature.
While SUI and POP had been treated using various techniques by uro-gynecologists for years, trans-vaginal mesh manufacturers entered this market and sold their products as being minimally invasive and safe because polypropylene is chemically inert. The manufacturers convinced the FDA that extensive clinical testing was unnecessary because mesh had been successfully employed in hernia operations for years and the SUI and POP procedures were really no different than hernia repair. Based on these representations, the FDA granted Section 510(k) approval to these manufacturers to market the products without first conducting extensive clinical testing.
In the past decade, while manufacturers continue to aggressively market these products, it has become painfully apparent that hernia repair and gynecological surgery are not substantially equivalent. While the surgical site for hernia repair constitutes a “sterile field,” the female pelvis and its organs does not. And while polypropylene may be chemically inert, it is not biologically inert, i.e., it can get stiff, bend and move; it can serve as a bacteria “magnet,” and problems which have arisen for thousands of implant patients include erosion, contraction, extrusion, protrusion, chronic infection, migration and chronic, life-altering pain. Because of these multiple, varied complications, many physicians do not recognize what is causing the patient's problems, and it is believed that adverse event reporting to the FDA is substantially under-reported.
However, despite industry protests to the contrary, the FDA recently reclassified mesh products as Class III (the highest risk) devices due to the danger involved with POP procedures. Such a reclassification has not yet occurred with respect to SUI procedures although the issues involved are almost identical.
One of the chief and most troubling problems with mesh complications is the difficulty in removing the product once it has been embedded in patients for a number of months. While manufacturers extol its ease of implantation, mesh in a very great number of cases cannot easily be removed and many women require multiple procedures in an attempt to do so. Needless to say, as the number of procedures increases, so does the increased risk of compromise to the patient's pelvic parts. Because of the available alternatives to patients prior to the introduction of these mesh products for POP and SUI procedures, the head of the Mayo clinic has written that hundreds of the women having had polypropylene mesh implanted “have suffered needlessly.”
If you or a loved one have suffered complications from a trans-vaginal mesh contact Showard Law Firm at (520) 622-3344 or toll free at (866) 307-2147, for a free consultation.