What is the FDA expedited approval process and why do so many unsafe products end up on the U.S. market after expedited approval? | DENENA | POINTS

The FDA expedited approval process is a reaction to the fact that in-depth testing and clinical trials of products are expensive and take a long time. Requiring a full testing and clinical trials regimen would present a significant barrier to product entry for many manufacturers and their products. Because of the pain and suffering we’ve seen from untested products like vaginal mesh implants our Pearland, Texas drug recall attorneys believe that stronger barriers to product entry on the market might not be a bad thing.

 When the FDA received its authority to approve drugs, supplements, and medical devices, as a practical matter the agency decided it could not go back and send all products and medical devices already on the market through a lengthy and expensive testing and clinical trial program. So the FDA pronounced that medical devices that were already on the market could remain there without additional testing. When some of those products later proved dangerous, the FDA issued product recalls.

 The FDA 510(k) expedited approval process also allowed new products that were “substantially equivalent” to existing products to go onto the market without additional testing. And our Pearland, Texas drug recall attorneys point out that over 90% of all products introduced since the FDA received its regulatory authority have reached the market under the 510(k) expedited approval process.

 As an example of the weaknesses of the FDA expedited approval process, we mention the implantable vaginal mesh that is now the subject of thousands of lawsuits across the nation. The mesh itself was of the same type as the mesh that had been successfully used for some time to repair hernias. Therefore, vaginal mesh manufacturers said that it was “substantially equivalent” to the hernia repair mesh and unfortunately sent it out onto the market under the FDA expedited approval process without additional testing or clinical trials to see what its results would be in patients.

 The vaginal mesh was implanted into thousands upon thousands of women who are now suffering grievous effects of the medical devices. Our Pearland, Texas drug recall attorneys note that a hernia repair is a much simpler and less invasive procedure than a transvaginal mesh implant designed to repair pelvic organ prolapse. This seems transparently obvious, so that one might think that maybe somewhere along the line, the FDA or even prolapse repair surgeons might have raised questions and flagged the expedited approval of the vaginal mesh implant. Safety advocates, some lawmakers, and concerned medical professionals are now calling for closer regulation FDA of new medical devices, supplements, and other products.

 The Pearland, Texas Drug Recall Attorneys are Now Accepting Additional Vaginal Mesh Injury Cases

 Contact us at 281-369-4363 or fill out our online contact form to schedule a FREE and confidential, no obligation legal consultation to discuss your injury and evaluate your potential eligibility for financial compensation. We’ve already begun the process of gathering evidence and developing strong claims on behalf of clients injured by the vaginal mesh implants. We could help you too. We’re Board Certified Texas personal injury trial lawyers. Let our more than 15 years of experience successfully resolving complex personal injury claims help you in your time of need. Contact us today.