Technological improvements and advancements to mesh products continue to happen, helping surgeons, and ultimately, their patients. According to the Society of American Gastrointestinal Endoscopic Surgeons, about 600,000 hernia repair operations are performed in the U.S. each year. Although a number of problems and recalls of mesh material have occurred over the years, repairing an abdominal hernia with mesh is still the preferred method over suture repair.
A study published in 2000 compared patients who had hernia mesh repair to suture repair patients. About three years after their surgeries, 43 percent of patients who had suture repair had hernia recurrence, compared with 24 percent of those whose hernias were repaired with mesh.
But even mesh products can have their drawbacks. In 2006, the U.S.Food and Drug Administration (FDA) recalled Proceed Surgical Mesh products because the layers separated, and when the polypropylene layer was exposed to the bowel, patients had an increased risk of adhesions and bowel fistulization. Similarly, in 2005, the FDA recalled ComposixKugel Mesh Patches because they could break, causing bowel perforations or fistulas. The Composix product recall was expanded in 2006 and 2007 to cover other product models.
Recently the FDA has ordered new safety studies for surgical mesh implants that are used to hold pelvic organs in place. The agency is concernedabout a spike in the number of complications seen for female patients, including erosion and infection. Due to this spike, the FDA may also reclassify hernia mesh implants into a higher-risk category that would require manufacturers to conduct clinical trials in people before receiving approval for sale.
There have been more than 1,500 reports of complications with mesh from 2008 to 2010, which is five times the rate reported from 2005 to 2007. The devices, made of synthetic or biological material, which the FDA is focusing on in these cases, were commonly implanted to repair weakened or damaged tissue and provide support in cases of pelvic organ prolapse (POP).
In a new 2011 warning, the FDA now recommends that doctors and healthcare providers do the following:
• Recognize that, in most cases, POP can be treated successfully without mesh.
• Know that surgical mesh is a permanent implant that can make any future surgical repairs more challenging, and can put the patient at risk for additional complications and surgeries.
• Consider that mesh placed abdominally for POP repair may result in lower rates of mesh complications compared to transvaginal POP surgery with mesh.
• Be sure that patients are aware of the risks and benefits of transvaginal POP repair with mesh, and inform patients if mesh is being used.
The FDA now also recommends that patients undergoing surgery do the following:
• Ask the surgeon before surgery about all POP treatment options, including those that do not involve mesh, and understand why the surgeon may be recommending treatment of POP with mesh.
• Continue with routine check-ups and follow-up care after surgery. Notify the surgeon if complications develop (persistent vaginal bleeding or discharge, pelvic or groin pain during sex, etc.)
• Those patients who have had POP surgery, but don’t know if the surgeon used mesh should find out if mesh was used during their next scheduled visit with their healthcare provider.
Despite being the safest choice, new considerations are emerging concerning the use of mesh. This, in turn, fuels the continued development of improvements in surgical mesh products.