Read on its own, the FDA’s report on transvaginal mesh used in pelvic organ prolapse surgery makes a reader assume the product is soon to be recalled. However, many medical professionals say that each individual surgeon’s relative skill and experience level have far more to do with whether the surgery will be successful. From the general sentiment expressed by surgeons, it seems to me that the horrible health problems women are having after pelvic organ prolapse surgery should actually be blamed on poor surgical practices. The FDA report did one good thing – it shed light on the tendency of pelvic organ prolapse surgery to fail, and has stoked the fires of controversy. In the past, patient reports related to pelvic organ prolapse repair surgery failure were less common – perhaps because of the very private nature of the problems that can result. Now, as women see how many others have suffered similar humiliation, pain and suffering, they’ll likely come forward to tell their own stories. Manufacturers of transvaginal surgical mesh have started to face vaginal mesh attorneys representing patients who believe they’ve been harmed by the product.
Pelvic organ prolapse is a circumstance that can happen to women after childbirth, after hysterectomy, or during menopause. In simple terms, the condition occurs when the pelvic muscles become damaged or stretched and can no longer support one or more pelvic organs. The organs then prolapse, or sag, into the vaginal cavity – and can even push out of the vagina Many women (up to 50%, some reports say) experience some degree of prolapse during their lives. The circumstance can affect normal urinary and sexual functions. Surgery is required to repair the condition in the most extreme cases. It is the use of surgical mesh in the form of a pelvic sling that has become the focus of transvaginal mesh lawyers and their clients. The 2010 FDA safety alert on this subject blames transvaginal mesh for a wide range of serious and potentially permanent health problems.
Some urogynecologic surgeons call into question the efficacy of the FDA report, stating that surgery is more apt to fail or succeed because of a surgeon’s level of skills than any other single factor. Surgeons that rely on pre-packaged prolapse kits may be more apt to do a shoddy job. The FDA concluded that in many cases, regular stitches are safer than vaginal mesh; this may be because surgeons who are more competent and confident are more likely to trust their skills to make the repair as they see fit, rather than relying on a product developed by a medical device company. In any case, many medical professionals believe that transvaginal surgical mesh is only a part of the problem, and that a surgeon’s abilities will ultimately decide the outcome of a pelvic organ prolapse repair procedure. For now, transvaginal mesh attorneys have turned their sights on companies such as Johnson & Johnson, who manufacture and market prolapse repair kits. The FDA is expected to make a further pronouncement on the topic this autumn after a special review committee convenes.