Consumer Advocacy Efforts to Ban Pelvic Surgical Mesh Due to Serious Health Risks
A consumer advocacy organization known as Public Citizen has called upon U.S. government regulators to issue an immediate ban against pelvic surgical mesh implants. In fact, the group sent a formal petition to the U.S. Food and Drug Administration (FDA) in Washington, D.C., to seek the controversial medical product's complete ban. These consumer-oriented advocates assert that the pelvic mesh at issue subjects patients to serious, under-reported, undisclosed, and detrimental health risks.
More Stringent Testing and Reclassification of Pelvic Surgical Mesh Medical Products Proposed
Consumer advocacy groups such as Public Citizen and the FDA share concerns that the pelvic surgical mesh medical products that were widely used to repair female pelvic conditions are now in dire need of more stringent testing. It is hoped that the more stringent testing currently proposed will ensure overall product safety and effectiveness. Apparently, the FDA unfortunately used a short-circuited and abbreviated medical product approval process for originally clearing usage of the pelvic surgical mesh. Additionally, a panel of independent health consultant advisers has implored the FDA to consider entirely reclassifying pelvic surgical mesh. Some prior pelvic surgical mesh patients now complain that the U.S. regulatory system has failed to protect patient consumers by not mandating the requisite battery of extensive tests before it permitted pharmaceutical manufacturers such as Johnson & Johnson to sell the pelvic surgical mesh implants on the open market.
What Is Pelvic Surgical Mesh?
The pelvic surgical mesh at issue is inserted through the vagina and is used to treat the condition of female pelvic collapse. Specifically, the mesh is used to support a woman's weakened pelvic muscles that cannot hold her pelvic organs in the proper position any longer. Symptoms of those experiencing complications from pelvic surgical mesh include the following:
- pain at various levels
Complications From Pelvic Surgical Mesh Implants Worse Than Anticipated and First Reported
According to FDA statistics, approximately 75,000 women had prolapse surgery in 2010 with a type of pelvic surgical mesh implanted. The FDA subsequently released information, in the summer of 2011, indicating that complications from pelvic surgical mesh implants are both more frequent and more severe than the number of incidences that initial estimates reported.
Connect with an Attorney nowCall 877.913.7222