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Rottenstein Law Group Acknowledges Consumer Reports Magazine for Publicizing Dangerous Drawbacks of FDA’s Medical Devices Approval Process


(New York, NY, April 3, 2012) The Rottenstein Law Group, which represents clients with claims stemming from the adverse effects of vaginal mesh, applauds Consumer Reports for publishing an investigative report describing the shortcomings of the U.S. Food and Drug Administration’s (FDA) medical device approval process.
The article, titled “CR Investigates: Dangerous medical devices,” is dated May 2012, but can be found on the magazine’s Web site. It states that Consumer Reports’ investigation into the FDA’s medical device approval process, which included “interviews with doctors and patients and an analysis of medical research and a device-safety database maintained by the FDA,” bore out the following three “areas of concern:”

  • Medical devices often aren’t tested before they come on the market.
  • There’s no systematic way for the government, researchers or patients to spot or learn about problems with devices.
  • Without major changes in the system, there’s not much patients can do to protect themselves.

The article goes on to describe the plight of three victims of the FDA’s insufficient medical devices approval process. One of those victims had to endure eight surgeries to adjust and remove surgical mesh that a surgeon implanted through the victim’s vagina in order to correct a condition known as pelvic organ prolapse. The mesh implant caused the victim extreme pain, and left her with nerve damage in one leg. She is now one of thousands of women suing the implant’s manufacturer.
The Consumer Reports article explains that the manufacturer of the victim’s vaginal mesh implant, and products like it, “took advantage of a loophole in the law that allowed them to grandfather their products onto the market without any advance safety testing. The agency routinely clears new devices...without clinical testing as long as manufacturers can show they are ‘substantially equivalent’ to a device that has already been on the market.”
The Rottenstein Law Group has long been publicizing the fact that many vaginal mesh products were granted FDA approval without having been tested on humans based solely on the products’ substantial similarity to implants that were once approved by the FDA by subsequently taken off the market for safety reasons. The firm has even commissioned an infographic that illustrates the history of the FDA’s approval of dangerous vaginal mesh products.
Anyone seeking more information about transvaginal 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.


 medical devices
 vaginal mesh
 pelvic organ prolapse

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