Product Liability

FDA reviews safety of transvaginal mesh

The Food and Drug Administration (FDA) this week is reviewing the safety of surgical mesh used to repair pelvic floor disorders based on a recent report that found transvaginally implanted mesh fail to lead to better outcomes than non-mesh repairs and should be reclassified as posing a high risk to patients. Patient groups are also demanding a recall of the so-called moderate risk devices, saying they were permanently injured by the products.

Surgical mesh products are made of non-absorbable synthetic material and are used during transvaginal surgery to repair pelvic organ prolapse (POP), a common condition in women caused by age, obesity or childbirth. POP occurs when the pelvic organs, such as the bladder, rectum or uterus, bulge or descend into and sometimes past the opening of the vagina. Eighty-five surgical mesh devices to treat POP have been approved for use by the FDA between 1992 and 2010.

About 300,000 women underwent surgeries to address POP and incontinence in 2010, and an estimated 75,000 of those involved the transvaginal implantation of surgical mesh. The FDA has received 1,503 reports of complications associated with the devices from January 2008 to December 2010. Those problems include mesh erosion, pain and urinary incontinence, oftentimes requiring more hospitalizations or surgeries. In some cases the injuries were permanent. In July, the FDA issued a safety warning about potential problems involving transvaginal mesh.

As part of its review, the FDA said it is considering whether to order Johnson & Johnson, Boston Scientific Corp, and other manufacturers of surgical mesh to submit additional safety data. There is no word when the agency is expected to give a recommendation.

The Journal Gazette