A clinical procedure called trans-vaginal mesh (TVM) implantation has already established a reputation until disturbing reports of its fatal consequences came out in big figures and stirred the public lately. Filed lawsuits against this procedure are piling up as the population of discontented recipients keep growing.
Trans-vaginal mesh procedures are intended to be carried out to treat Pelvic Organ Prolapse (POP) and Stress Urinary Incontinence (SUI). Trans-vaginal mesh (TVM) implantation is frequently performed for the surgical management of Pelvic Organ Prolapse (POP) and Stress Urinary Incontinence (SUI). POP and SUI affect a great percentage of the adult women population all over the world. This results to more women undergoing TVM surgery.
The U.S. Food and Drug Administration (FDA) alerted the public about the potential risks caused by this procedure in 2008, and has been actively conducting investigations regarding the possible reclassification of vaginal mesh and is now studying the need of regulatory changes like clinical testing addressing the benefits and risks of using vaginal mesh for POP and SUI.
How is a recall initiated?
In a recall, the FDA suppresses the availability of a medical device or drug in the market after negative comments relating to the safety and effectiveness of that particular product are received from consumers. 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?
Recalls are grouped into three classifications. Recalls which are most likely to cause debilitating injuries or death are classified as category I. Category II are those recalls that don’t frequently cause serious health threat but may pose a temporary negative 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 should vaginal mesh products 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. Representing over 225,000 concerned individuals, Public Citizen requests that selling of non-absorbable surgical mesh be discontinued because its advantage over non-mesh procedures as treatment for POP and SUI are not defined, and most patients who received it had developed high-risk and life-changing complications. The group also suggests that the FDA should approve all the non-absorbable vaginal mesh proposed to be marketed in the future only after adequate clinical trials that ensure their safety and effectiveness.
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 considering the expanding of monitoring the device performance. The FDA is encouraging the recipients of TVM and all medical professionals to immediately report adverse reactions to the FDA to better understand the causes of these complications.
References:
fda.gov/downloads/MedicalDevices/Safety/AlertsandNotices/UCM262756.pdf
fda.gov/downloads/MedicalDevices/Safety/AlertsandNotices/UCM262760.pdf
fda.gov/MedicalDevices/Safety/AlertsandNotices/TipsandArticlesonDeviceSafety/ucm169802.htm
Joe's Vaginal Mesh Recall Blog 