Johnson & Johnson vaginal mesh lawsuits another blow to the FDA's device review process
October 20, 2011 by Arezu Sarvestani
With high profile recalls in hip implants and defibrillators in the recent past, the FDA's medical device review process takes another hit it doesn't need as health care giant Johnson & Johnson weathers a storm of transvaginal mesh complaints.
The FDA's medical device review process is again under scrutiny as lawsuits pile up against health care leviathan Johnson & Johnson (NYSE:JNJ) for transvaginal mesh devices that may do more harm than good.
Lawsuits claiming negligence against mesh-makers have also implicated the FDA's review system for continuing to clear new mesh products under the 510(k) system, despite the predicate device being pulled from U.S. shelves.
Boston Scientific Corp.'s (NYSE:BSX) ProteGen mesh, cleared in 1996 and pulled from the shelves a year later, was used as a predicate device for clearing subsequent mesh products, despite more than 120 adverse event reports on the original design at the time, Bloomberg reported.
Sign up to get our free newsletters delivered right to your inbox.
Similar entries
"The FDA got caught with their pants down," California pelvic surgeon Thomas Margolis told the news service. "The ProteGen should have told them, 'Wait a minute, all of these mesh systems are bad.'"
- Show full page
- Login to post comments
-
Permalink
RECENT BLOG POSTS
- Mobilizing on the back end of a disaster
- Rising healthcare costs not directly tied to medical technology, according to study
- CareFusion may be weighing 2 very different deals
- Medical Devices: What does it really mean to be disruptive?
- Smarter strategic moves bode well for Wright Medical
- The IRS, NSA, and Justice Department scandals and what they mean for HIPAA
- A Father's Day remembrance
- What I'd tell the graduating medical school class of 2013
- Silencing immune attacks in type 1 diabetes
- Eucomed guidance clarifies RoHS compliance for medical device companies
Navigation
NEWS
Medical device tax: Consultant calls offshoring concerns 'horse hockey'
Concerns that the medical device tax will push companies to lay off workers and move operations...
FDA clears OrthoSensor's Verasense knee replacement device
The FDA clears OrthoSensor's Verasense device, designed to help surgeons fit knee replacement...
ArtVentive Medical wins CE Mark for peripheral catheter
ArtVentive Medical Group wins CE Mark approval in the European Union for its EOS peripheral vascular...
Recalls: FDA makes Endologix catheter introducer recall Class I
The FDA hits Endologix's catheter introducer device recall with Class I status, its most serious...
pSivida gains big on buyout rumor
A blogger's speculation that pSivida might be in line for a buyout bid sends the ophthalmology...
