Trans-vaginal mesh (TVM) surgery has been well-known for quite some time until numerous complaints of its deadly complications surfaced and made a commotion in the public recently.   Filed lawsuits against this procedure are piling up as the population of discontented recipients keep growing.

The implantation of trans-vaginal mesh (TVM) is practiced for the clinical repair of Pelvic Organ Prolapse (POP) and Stress Urinary Incontinence (SUI). These medical conditions affect many adult women in all sides of the world.  With this, more and more women are exposed to TVM surgery.  This means that many more women are subjected to TVM procedure.

An announcement was made by the U.S. Food and Drug Administration (FDA) in 2008 covering the complications posed by TVM surgery; and investigations on the reclassification of the vaginal mesh and the need for regulatory changes like the availability of studies directing the advantages and negative effects of this medical device were also being considered by the agency. The U.S. Food and Drug Administration warned the public of the deadly consequences associated with this procedure in 2008, and has been doing investigations on the risks and benefits of TVM and the possibility of reclassifying this medical device.

What happens during a recall?

A recall takes place when the FDA receives reports from either medical professionals or patients of detrimental reactions of a drug or medical device and removes this particular device from the market.   The recall of a medical device or a drug from the market must be justified by the tendency of it causing serious injuries or even death.

How is a recall classified by the FDA? How does FDA classify recalls?

The FDA sorts recalls into 3 categories.  Category I are recalls classified to cause serious complications or mortality.  Recalls sorted as category II are those products that may cause reversible adverse effects.  In category III recalls, products are not frequently related to serious health complications.  After a recall is accomplished, the FDA ascertains that the recalled products are destroyed and appropriately reconditioned.

Why are vaginal mesh products necessary to be recalled?

In October 25, 2011, a consumer advocacy group called Public Citizen submitted an appeal to the FDA that all non-absorbable vaginal mesh be recalled. They stressed that there is a need for these non-absorbable vaginal meshes to be removed from the market since it’s benefits over other non-mesh procedures used to repair POP and SUI were unseen, and patients who received them developed fatal reactions.  The group also recommends that all non-absorbable vaginal mesh be tested appropriately for safety and effectiveness before the FDA approves its availability in the market.

It is not clear when the FDA will make a decision about this request, but it is currently doing investigations on the surgical meshes involved with all the reported complications. The FDA is also planning to broaden the scope of device performance monitoring.  To understand the risks caused by TVM procedure, the FDA is asking help from health professionals and involved patients to participate in this investigation by reporting negative reactions.