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Spokesman: Mesh implant production not halted due to lawsuits

New Orleans, Louisiana, women may be aware that there are more than 1,000 product liability lawsuits pending against the branch of Johnson & Johnson that produces vaginal mesh implants. This week, a representative of the company announced that the company asked the U.S. Food and Drug Administration for permission to halt sales of four related products in the next four months.

Women reporting serious injuries and organ damage from such devices sued healthcare companies and mesh producers recently. The company spokesman said this was not a product recall but rather a discontinuation not related to the pending lawsuits.

The mesh implants were designed to repair damaged or weakened tissue and support pelvic organs in case the tissue surrounding it weakens due to menopause, childbirth, or hysterectomy. Patients suffering from stress urinary incontinence also used the product for relief from their overactive bladder. According to figures from the FDA, approximately 75,000 women received the implant for pelvic organ relapse and around 200,000 for bladder conditions in 2010.

According to the FDA, earlier this year they asked mesh producers to further study the device's safety. The agency also claimed they might require manufacturers to perform trials in people before granting sale approval by reclassifying the risk category of the product.

The company's spokesperson claimed they were giving doctors an opportunity to find alternatives to the product by spreading the discontinuation over a few months. The decision to discontinue stemmed from the negative publicity surrounding the product, he explained. He also mentioned the company would continue to produce related products.

The FDA reported that it received about 1,500 complaints of complications caused by the mesh between 2008 and 2010, five times the rate of complaints received between 2005 and 2007.

Source: Reuters, "J&J to stop selling controversial vaginal implants," Anna Yukhananov and Ransdell Pierson, June 5, 2012

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