by Ryan L. Thompson on 02/03/2012
A medical device safety bill was introduced recently, wherein U.S. regulators would be able to block medical device approval based on past products with safety issues. Proponents of the bill reference the hundreds of thousands of injuries sustained by transvaginal implant patients with devices like those made by Johnson & Johnson and C.R. Bard Inc. Vaginal meshes were implanted in hundreds of thousands of women as part of a surgery for pelvic organ prolapse or stress urinary incontinence. The FDA last month ordered safety studies from Johnson & Johson, C.R. Bard, and Boston Scientific.
The medical device bill introduced this week would close a loophole that lets devices win approval even when they are substantially similar to an already recalled dangerous medical device product. The most substantial change made by the bill is that it would allow the FDA to refuse “pass-through” approval based upon past equivalent devices if those devices were removed from the market or if the agency were in the process of pulling it. It also would require companies to explain why their products are different from recalled versions.
Vaginal implant adverse reporting led to an alert last year from the FDA after thousands of patients complained of internal injuries, many requiring revision surgeries. The devices were cleared by the agency’s 510(k) device approval system, which allowed them to be sold without any human testing.
Complications from a transvaginal mesh, tape or sling can include:
- Erosion of the device through the vagina
- Revision surgery
Our mass tort and medical device litigation team at Watts Guerra Craft LLP is watching house bill HR3847 closely. We believe it has the potential to help prevent situations like the current transvaginal mesh, tape and sling litigation. If you need help or have questions about a defective medical device, contact us today.blog comments powered by Disqus