Were Some Vaginal Mesh Devices Marketed Without FDA Approval?
The Life Solutions Group discusses a recent report regarding claims that a transvaginal mesh manufacturer marketed the device without FDA approval. "
11/12/2013 // TWM // The Life Care Solutions Group
Recent claims by a woman who filed a lawsuit against pharmaceutical giant Johnson & Johnson alleging the company marketed the device without approval by the U.S. Food and Drug Administration have made headlines. The case was filed on behalf of the female plaintiff in an Israel District Court, with legal representatives seeking to have the claim certified as a class action lawsuit. A reported 60,000 women in Israel have sustained injuries related to the Prolift transvaginal mesh device according to the lawsuit, which is seeking compensation in the sum of NIS 6 billion ($1.7 billion).
The situation in the aforementioned case in Israel is similar to the circumstances many women face in the United States who have chosen to seek legal compensation from the manufacturers of vaginal mesh or sling devices. Thousands of women in this country have documented medical evidence of health complications associated with being implanted with the mesh for conditions such as pelvic organ prolapse and stress urinary incontinence.
Since the initial release of information from the FDA regarding the serious health risks associated with mesh implants, more and more women have stepped forward to acknowledge that they have been injured, according to the Life Care Solutions Group. Questions regarding the legality of manufacturers continuing to market and make available similar devices that have caused numerous patients harm have also resulted.
The Life Care Solutions Group is available to help women who have questions about their medical and legal options for those who have been injured by a transvaginal mesh device. Individuals may contact the group today to request a free case review or for more information on how to receive help for a specific TVM injury.
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