Mesh implants for women may have to undergo additional testing
Surgical mesh implants used to hold women’s pelvic organs in place have been singled out by federal regulators for new safety studies. The Food and Drug Administration has received more than 1,500 complications reports that led to problems including infection and erosion.
Potentially thousands of women might be affected by the government’s ruling in this product liability case. The devices in question are implanted when it becomes necessary to repair damage or weakened tissue, and to provide internal support for sufferers of pelvic organ prolapse, or POP. Another use is to aid women who suffer from stress urinary incontinence, or a severe overactive bladder.
As many as 50 percent of women may have POP in their lifetime, and about two percent will develop symptoms. Surgery aimed at supporting the prolapsed organs can be done with stitches or, increasingly in recent years, with surgical mesh.
The mesh treatment has been used in surgical applications for more than 50 years, and when companies began to manufacture it specifically for use in addressing POP and stress urinary incontinence, they did not have to do clinical trials in people. The requirement at the time was that the new devices had to be shown to be similar to items already on the market.
The FDA, however, is now reconsidering that notion and might reclassify the devices into a higher-risk group that would require clinical trials. This could affect thousands of women in California who might be in line to receive the devices, or have already received them. Anyone concerned with the effects of a potentially dangerous product may wish to contact an attorney to review their options.
Source: Reuters, “FDA wants new studies on surgical mesh impacts,” Anna Yukhananov, Jan. 5, 2011