J&J Marketed Vaginal Mesh Implants Despite Halt Order by FDA

FDA

The shaky regulatory history of the Gynecare Prolift vaginal mesh implant system could lead to additional legal troubles for the manufacturer, Johnson & Johnson. The Prolift product is marketed by Johnson & Johnson’s Ethicon division. J&J is one of the world’s largest healthcare products manufacturers.

According to a letter dated August 24, 2007, J&J was informed by the Food and Drug Administration (www.fda.org) to halt marketing of the device until further investigations were made into whether or not the device was “substantially equivalent” to other J&J devices which had been previously approved.

J&J cites FDA regulations which allow the marketing and selling of devices without approval if the device is similar to a previously approved product. For nine months J&J and the FDA exchanged communications about the product, with the FDA eventually approving the Prolift system in 2008. However, in the intervening nine months, when J&J had been told to pull the product from the market, it continued to market and sell the device.

J&J now faces more than 1,400 transvaginal mesh implant lawsuits, claiming the implants have caused internal injuries including organ perforation, infection and other health issues. Vaginal mesh products are used to treat issues with incontinence or overactive bladder and to address issues with weakened pelvic muscles, which can occur for some women during menopause or after childbirth or hysterectomy.

In 2010, according to FDA statistics, 200,000 women received vaginal mesh implants for urinary incontinence. Additionally, 75,000 implants were used to treat pelvic organ prolapse.

Issues with the vaginal mesh implants began to surface last year when the FDA reported a spike in adverse events including death, injury or malfunction with the devices. Further safety studies were requested from the manufacturers earlier this year and in a move towards additional investigation, the FDA convened an advisory panel to review current clinical data for the devices. The panel recommended that the devices be reclassified as “high-risk” which would then require manufacturers to hold clinical trials of the devices on human subjects.

In a related move, J&J recently informed a federal judge in West Virginia that it will discontinue sales of its Prolift line of vaginal mesh products.

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