The U.S. Food and Drug Administration (FDA
) have instructed medical device manufacturers to examine safety complications in relation to a type of surgical mesh which is widely used to repair women's pelvic problems. According to Reuters
the FDA received over 1,500 reports of complications related to the use of such meshes between 2008 to 2010, and that the level of complaints has risen throughout 2011. Although surgical meshes have been used for many years for different types of surgery, the application of meshes for pelvic operations is relatively new.
Due to a series of concerns the FDA has instructed some thirty-three manufacturers of medical meshes to undertake retrospective safety studies and for these reports to be submitted back to the FDA for evaluation. The manufacturers required to undertake further analysis include Johnson & Johnson, Boston Scientific Corporation, and CR Bard Inc.
The surgical meshes are manufactured from either synthetic or biological materials. The meshes are implanted in women to repair weakened or damaged tissue as an alternative to conventional stitches. Surgical pelvic mesh products provide support for a woman’s organs in the pelvis, which may drop, fall, or protrude (prolapse) due to weakened or stretched muscles that occur from childbirth, pregnancy and other causes. The devices also support the woman’s body in cases of pelvic organ prolapse
and stress urinary incontinence
as part of urogynecologic procedures.
The latest FDA request follows a previous inquiry by the agency. This study, from 2011, revealed that women who have had a type of surgical mesh implanted to support their reproductive organs are actually at an enhanced risk of pain, bleeding and infection compared to women who have undergone traditional surgery with stitches.
Star Tribune Business
stated that the consequence of the FDA action is that the mesh may be reclassified as a high-risk device. The change in classification would require manufacturers to perform a comprehensive product safety test before release. This will take time and cost the manufacturers far more in development and manufacturing expenses.
The Boston Globe
speculates that the FDA notification will lead to a flurry of lawsuits, especially if it is proven that adequate safety tests were not carried out.