June 26, 2012 — Documents recently unsealed in the ongoing transvaginal mesh lawsuit against Johnson & Johnson reveal that the company continued to sell vaginal mesh devices for nine months after the U.S. Food and Drug Administration (FDA) ordered the company to halt marketing the products in 2007. The company was never cited for selling the device without gaining FDA approval, nor was it cited for continuing to sell the products after the 2007 FDA warning letter.
The 2007 letter specifically warned that J&J must gain FDA approval before it could market its vaginal mesh products. Furthermore, the FDA requested that J&J provide the agency with more information on 16 different potential deficiencies with the product. The FDA letter warned, “If you market the device without conforming to these requirements, you will be in violation of the Federal Food, Drug and Cosmetic Act.”
Typically, when companies sell products without gaining FDA approval, or continue to sell illegally adulterated products, they face fines, injunctions against their executives, and forcible seizures of their products.
In this case, however, J&J and the FDA entered into talks. In 2008, the FDA decided to re-allow marketing of the vaginal mesh products. J&J faced no sanctions, because the FDA said the company “promptly complied” with the FDA’s request for a new device application.
The controversy stems from J&J’s Gynecare Prolift, which J&J began selling in 2005 without conducting any safety studies or gaining FDA approval. J&J defended its actions by saying that it independently determined that the Prolift was substantially similar to J&J’s ProteGen.
The FDA disagreed. In 2007, the agency sent J&J a warning letter requesting that the company submit an approval application. The FDA had received more than a hundred reports of serious injury, malfunctions, or death associated with the device. Recently, the FDA determined that vaginal insertion of the devices increased the risk of injury, malfunction, or death by a five-fold rate.
Hundreds of thousands of women have been implanted with transvaginal mesh devices — 300,000 just in 2010. The hammock-like mesh devices are intended to help support sagging pelvic muscles, which is a common complication of pregnancy. The condition can cause Pelvic Organ Prolapse (POP) or Stress Urinary Incontinence (SUI). While studies suggest that vaginal mesh is effective for treating incontinence, it comes with some serious risks. These side effects include organ perforation, abscess, infection, nerve damage, scarring, and erosion of the mesh into surrounding tissue areas. Most women who have these serious complications must undergo corrective surgery.
In July 2012, J&J announced that they will cease all marketing and sales of the Prolift and other vaginal mesh products.
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