Bloomberg News (6/26, Voreacos, Nussbaum)
reports, "Johnson & Johnson... continued to sell a vaginal mesh
implant for nine months after US regulators told the company to stop marketing
the device, according to court records." As revealed in court documents,
in a letter dated Aug. 24 2007, "the US Food and Drug Administration told
J&J...to halt Gynecare Prolift sales until the agency decided whether the
device was 'substantially equivalent' to other products on the market. The FDA
cited the 'potential high risk for organ perforation' when surgeons insert the
mesh vaginally to support weakened pelvic tissue." The agency told J&J
that it would be violating the Federal Food, Drug and Cosmetic Act if it
marketed the device without conforming to certain requirements and if it did
not have FDA approval.
No comments:
Post a Comment