J&J issues recall for Gynecare transvaginal surgical mesh

by Heygood Orr and Pearson

Johnson & Johnson has announced that it will recall several models of its Gynecare transvaginal surgical mesh patches after they were linked to reports of serious injury or death among patients. The products were sold by Ethicon, a division of Johnson & Johnson.

In 2008, the Food and Drug Administration warned about the safety of transvaginal mesh products, which can be used for the surgical repair of pelvic organ prolapse or stress urinary incontinence. According to the agency, surgery with transvaginal mesh is no more effective than traditional surgical repair, but carries an additional risk of complications.

Hundreds of transvaginal mesh lawsuits against the manufacturers of these devices have been filed by patients who experienced complications from their device following surgery. Other surgical mesh manufacturers besides Johnson & Johnson include Boston Scientific, C.R. Bard and Endo Pharmaceuticals.

Critics have faulted the FDA’s approval process for products such as transvaginal mesh, which allows some products to be sold without undergoing clinical testing if they are substantially similar to existing products. Johnson & Johnson’s Ethicon unit did not seek approval for the Gynecare Prolift mesh kit because it claimed the product was similar to Gynemesh, which had already been approved for sale.