FDA Considers Rigid Protective Rules to Wipe out the Harm of Pelvic Mesh Implants’ Usage

 

FDA desires to enforce more scrupulous safety requirements for surgical mesh implants. This action verifies and underscores the high and developing anxiety over safety matters regarding these implants, which are used to cure women’s pelvic problems. FDA deliberates stricter rules for these defective implants because the governmental agency aims to the reallocation of pelvic mesh implants to a high risk category as a medical device rather than a moderate risk.
 

It is world known that Johnson & Johnson, the dominant manufacturer of these medical devices has been sued by more than 22,000 patients for their defective pelvic mesh implants. These devices have reportedly caused overwhelming pain, infections, bleeding, and urinary problems to injured women. FDA has analyzed and pinpointed the unambiguous risks of surgical mesh implants through immeasurable patients’ reports and will take drastic measures soon to eliminate the risks and put on market harmless and competent medical products. Specifically, FDA will initiate to ask manufacturers to apply for pre-market permissions to FDA in order the agency to assess the medical device’s invulnerability and efficiency before setting the product on the market.