Patients considering having surgical mesh surgery for pelvic organ prolapse (POP) or a hernia repair may want to think twice. The Food and Drug Administration (FDA) on Wednesday, July 13, issued its second warning about the use of synthetic plastic mesh made by Boston Scientific, Covidien plc, CR Bard Inc., American Medical Systems and Johnson & Johnson after noting that in 2008 there was one death and five times the adverse events of 2005 to 2007.
At least 10 percent of patients have had to have multiple surgeries to try and remove the petroleum-based mesh after it migrated and eroded into organs, causing extreme pain and infections. It is almost impossible to remove mesh once it is implanted and scar tissue and inflammation forms around it.
In 2010, 75,000 female patients had surgery to repair pelvic organ prolapse, a condition where organs fall and press up against the vagina. The synthetic mesh is used to hold up the pelvic wall and is inserted through the vagina. An article in the Boston Globe quotes one surgeon who says the procedure through the abdomen has a much lower complication rate of about four percent.
Plastic mesh is also used for hernia repair and the FDA has received reports of adverse reactions to the mesh including adhesions, and mesh migrating to perforate nearby organs, nerves and blood vessels, chronic infection, pain, and hernia recurrence. In a rare mea culpa, the FDA scientists said the 2008 public health advisory calling the problem “rare” was wrong. Medical literature now suggests problems occur in at least 10 percent of women within 12 months of surgery.
Even with the high rate of complications, the FDA does not plan to remove mesh from the market at this time but urges patients and surgeons to first consider traditional surgery using stitches to tighten the pelvic floor which has a failure rate reported to be 20 to 45 percent. Plastic mesh was approved under the fast track approval for medical devices, largely unchanged since the 1970s, reports AP.
As with some drugs approved without adequate testing, many patients have found out that the plastic mesh medical device has more complications and risks than benefits. As evidence mounts against this defective medical device, a patient who suffers injures from synthetic mesh should be able to file a product liability lawsuit against mesh manufacturers for a defective design and the failure to adequately warn the public. Unfortunately in the meantime, thousands more women and men are having synthetic mesh surgeries to repair POP, incontinence and hernias every year.
Sources: http://www.boston.com/Boston/dailydose/2011/07/fda-warns-against-surgical-mesh-repair-pelvic-problems/Yf5Ukjj5JiACnJ515sPPVL/index.html and http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm142636.htm
