June 26, 2012 — According to court records, Johnson & Johnson continued to sell vaginal mesh devices for nine months after the U.S. Food and Drug Administration (FDA) ordered them to halt marketing the products on August 24, 2007. The company faced no sanctions because the FDA determined that J&J “promptly complied” when the FDA required the company to submit a new approval application. Prior to 2007, J&J’s Gynecare Prolift vaginal mesh had been sold without FDA approval.
In the 2007 letter, the FDA clearly stated that J&J could not market its vaginal mesh products until they gained FDA approval and provided adequate information on potential deficiencies with the product. They warned, “If you market the device without conforming to these requirements, you will be in violation of the Federal Food, Drug and Cosmetic Act.”
Despite this letter, J&J continued to sell vaginal mesh products while the company negotiated with the FDA over the future of the devices.
The controversy surrounding the transvaginal mesh products began several years ago, when the FDA began approving devices that were based on Boston Scientific’s ProteGen, which had been recalled in the 1990s amid safety complaints. J&J began selling the Gynecare Prolift in 2005 without submitting an approval application to the FDA, because the company had independently determined that the Prolift was “substantially similar” to the Gynemesh, a product that had already gained FDA approval.
The FDA disagreed with J&J, and sent a letter in 2007 requiring the company to halt marketing of the device and submit a new application. The FDA was concerned about the high number of reports of malfunctions, deaths, and serious injury. Recently, the FDA reported that the risk of death, injury, or malfunction increased five fold when the mesh was inserted vaginally.
Normally, when companies sell products without FDA approval, they face fines, injunctions against company executives, and seizures of the illegally marketed devices. However, J&J faced no sanctions, despite the fact that they continued to sell the vaginal mesh product for after the FDA’s 2007 warning letter.
Furthermore, just before the FDA cleared the vaginal mesh products in 2008, J&J agreed to place a warning label that the safety of the devices “have not been demonstrated in randomized controlled clinical trials.” However, instead they wrote that tests demonstrated its vaginal mesh products were substantially equivalent to earlier approved devices.
Transvaginal mesh devices are used to help support weakened pelvic muscles, a common complication of pregnancy, and the cause of Pelvic Organ Prolapse (POP) and Stress Urinary Incontinence (SUI). The hammock-like slings were implanted in approximately 300,000 women in 2010, although the use of the devices has declined in recent years. More and more women are reporting severe side effects, including infection, organ perforation, abscess, nerve damage, scarring, and erosion of the device into nearby tissue. Most of the complications required additional surgery.
Earlier this month, J&J announced that it will stop selling all four of its vaginal mesh products, including the Prolift.
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