Johnson & Johnson Draws Flak for Selling Vaginal Mesh Devices without FDA Clearance
Even before the lawsuit of Linda Gross against Ethicon could formally open, defendant Johnson & Johnson appeared to have been placed on the defensive following a report claiming that its subsidiary Ethicon did not have clearance from the Food and Drug Administration (FDA) to market its Gynecare Prolift product.
Media reports on the controversy revealed that Ethicon decided on its own to make the vaginal mesh device available for distribution on the basis of being “substantially equivalent” to Gynecare Gynemesh, a product which was cleared earlier by the FDA through the agency’s 510(k) prenotification process.
The FDA did not agree with this action and demanded that Johnson & Johnson comply with the requirements. The Gynecare Prolift was subsequently cleared by the agency in 2009 after having been in the market for over four years and could have very well exposed thousands of women to potential risks.
This product in question, and now the subject of litigation, was the same device used in treating Linda Gross for the treatment of her pelvic organ prolapse (POP) in 2006. Shorty thereafter, the former nurse from South Dakota started experiencing severe complications which resulted to injuries causing her endless pain and suffering.
Read More: First Johnson & Johnson Vaginal Mesh Trial Begins as Scheduled
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