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 transvaginal mesh used in women's pelvic surgeries. An FDA report found that women who had the surgical mesh implanted are at greater risk for 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 issues such as 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. Most commonly women with multiple births, due to the stress on the pelvic musculature caused by labor.
While SUI and POP have been treated using various techniques by uro-gynecologists, transvaginal mesh manufacturers entered this market and sold their products by marketing them as 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. 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 do not. And while polypropylene may be chemically inert, it is not biologically inert. This means it can become stiff, bend and move, and serve as a bacteria “magnet.” In addition to this, there have been several problems other problems such as erosion, contraction, extrusion, protrusion, chronic infection, migration and chronic, and life-altering pain. Because of these varied complications, many physicians do not recognize what is causing the patient's problems.
However, despite industry protests, the FDA recently reclassified mesh products as Class III (the highest risk) devices due to the danger involved with POP procedures. SUI, however, has not been reclassified.
One of the most troubling problems with mesh complications is the difficulty of removing the product once it has been embedded in the patient for an extended amount of time. While manufacturers extol its ease of implantation, mesh cannot be easily removed and many women require multiple procedures to attempt to remove it. Needless to say, as the number of procedures increases, so does the increased risk of compromise to the patient's pelvic area.
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