Johnson & Johnson ignored FDA demand
  • Wed, 06/27/2012 - 10:11am

Johnson & Johnson sold its Gynecare Prolift vaginal mesh implant for nine months after the Food and Drug Administration ordered the implant to be taken off the market, Bloomberg News reported yesterday.

The company began selling the product in 2005 because it believed the product to be “substantially similar” to its FDA-approved Gynemesh product. Johnson & Johnson did not, however, take the appropriate measures to gain 510(k) clearance, or premarket approval. According to the FDA’s website, a company has to “demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent, to a legally marketed device that is not subject to premarket approval.”

The FDA website goes on to say that premarket approval is its “most stringent type of device marketing application.”

Premarket approval is up to the FDA, not the company. Thus, the FDA sent Johnson & Johnson a letter in August of 2007 demanding that it stop marketing the Gynecare Prolift until the agency determined whether the product was in fact “substantially equivalent” to approved devices.

According to Bloomberg, the FDA found 16 possible deficiencies in the Prolift and warned Johnson & Johnson that it would be violating the Federal Food, Drug, and Cosmetic Act if it continued to sell the product.

The FDA eventually approved the Prolift in May of 2008, but according to ABC News, “Between 2008 and 2010, the FDA received 1,503 reports of injury, malfunction or death associated with the surgery.”

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About the Contributor

Kaitlin Gill
Cleveland
I report on news regarding product safety concerns for individuals and families.

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