Rottenstein Law Group Hoping European Breast Implant Recall Convinces U.S. Regulators to Rethink Proposal to Accelerate FDA’s Medical Device Approval Process
(New York, NY, January 24, 2012) The Rottenstein Law Group, which represents clients with claims stemming from the adverse effects of vaginal mesh, is in agreement with a January 19 Bloomberg article stating that the scandal over leaking French breast implants should convince U.S. regulators that American consumers would not benefit from speeding up the FDA’s medical device approval process.
For the past year, proponents of the European Union’s medical device approval process - which allows complex devices to reach consumers in European markets an average of two years sooner than in the U.S. - have been calling for the FDA to adopt a similar process, according to the article. Medical device industry supporters argue that the EU is luring device manufacturers away from the U.S., and contributing to high unemployment rates.
The breast implant debacle in Europe, which involves the removal of thousands of potentially faulty implants manufactured by the now-defunct French company Poly Implants Protheses SA, has brought negative attention to the EU’s medical device approval process, however. The European breast implant problem therefore should make U.S. regulators realize that it would be unwise to adopt a medical device approval process similar to the one in Europe, according to Carl Heneghan, an Oxford University teacher who has studied device recalls and is quoted in the Bloomberg article.
“All industry guys in the U.S. say, ‘we should have access to these products much sooner, like in Europe,’” the Bloomberg article quotes Heneghan as saying. “The flip side is, the European people are being used as guinea pigs.”
The importance of subjecting medical devices to comprehensive FDA reviews before they are approved for sale has been highlighted in recent months by the thousands of women in the U.S. who have suffered injuries as a result of vaginal mesh implants. The implants were granted FDA approval based on their similarity to devices already on the market, without the benefit of human testing. The implants have so far spawned more than 650 lawsuits filed by patients alleging that they have been significantly injured as a result of having surgical mesh products implanted transvaginally.
Anyone seeking more information about vaginal mesh can visit the Rottenstein Law Group’s Vaginal Mesh Lawsuit Information Center. The site has vital information about the dangers of this medical device, along with easy-to-use social media features that allow for easy sharing on sites like Facebook and Twitter. Visitors are also encouraged to link to their own Web sites and blogs in order to spread the word about defective medical products and dangerous drugs.
About the Rottenstein Law Group
The Rottenstein Law Group is a New York-based law firm that represents clients in mass tort actions. The firm was founded by Rochelle Rottenstein, a lawyer with over two decades of experience in compassionate representation of clients in consumer product injury, mass tort, and class action law suits. For more information, please visit their Web site, or call (888) 9-ROT-LAW.
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