Girardi | Keese

FDA proposal would re-classify pelvic mesh as 'high-risk'

In the late 1990s, medical device manufacturers began marketing a new product to surgeons that they said represented a significant step-up from traditional surgery in that it offered improved patient safety and altogether better outcomes.

The product in question was pelvic mesh, which is essentially a surgically-implanted plastic device designed to reinforce the pelvic walls of female patients suffering from a condition known as pelvic organ prolapse.

For those unfamiliar with this condition, which typically affects older women and woman who have given birth, it involves the bladder and other reproductive organs actually slipping into the vaginal area.

While the hopes for pelvic mesh were high given the previous success of mesh products to treat conditions unrelated to women's health (hernia, incontinence, etc.), the medical device soon presented serious health issues to patients, including infections, pain and bleeding.

Indeed, an analysis conducted by the U.S. Food and Drug Administration three years ago revealed that women who have pelvic mesh surgically implanted to correct pelvic organ prolapse as opposed to undergoing traditional surgery are more likely to experience complications.

Specifically, the agency found that 10 percent of pelvic mesh patients developed a condition known as mesh erosion in which the plastic mesh had actually eroded the vaginal wall into the surrounding organs and tissue. Of this 10 percent of women, half had to undergo surgery -- or several surgeries -- to repair the condition.

In recent developments, the FDA announced a proposal last week to reclassify pelvic mesh from a "moderate-risk" medical device to a "high-risk" medical device. If ultimately adopted, this would mean that manufacturers would have to submit comprehensive clinical data clearly demonstrating the safety and efficacy of the pelvic mesh product in order to secure FDA approval.

This move toward greater FDA oversight is not surprising when you consider all of the above plus the fact that over 22,000 personal injury lawsuits have been filed against just the leading manufacturer of pelvic mesh since its introduction.

Stay tuned for updates on the status of the FDA proposal.

If you have suffered serious personal injuries or lost a loved one because of a defective product, consider speaking with an experienced attorney to learn more about your rights and options for seeking justice.

Source: AP: The Big Story, "FDA wants stricter safety rules for pelvic mesh," Matthew Perrone, April 29, 2014

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