FDA Reviewing Vaginal Mesh

Surgical vaginal mesh for pelvic organ prolapse, or POP is being further investigated by a FDA panel.  The investigation is in part because nearly 300 lawsuits have been filed by women who have reported injuries including infection, organ perforation, urinary problems and mesh erosion as a result of having the mesh implanted.

The mesh supports pelvic floor tissues that weaken or stretch causing organs including the bladder, rectum or uterus to bulge into the vagina.  In August, a consumer group called for a recall of surgical mesh products made by Johnson & Johnson and Boston Scientific Corp.

Between 2008 and 2010, the FDA received 1,503 reports of injury, malfunction or death associated with pelvic organ prolapse surgery.  The mesh was approved quickly by the U.S. Food and Drug Administration using an abbreviated process known as 510(k).  Under the process, devices like the mesh implant can enter the market if manufacturers show they are “substantially equivalent” to others already for sale.

The attorneys at Messa & Associates are experienced at handling cases involving pharmaceutical and medical device injuries.  Our extremely skilled team of attorneys and medical experts are dedicated to ensuring your receive proper compensation for your injuries.  For more information or if you or a loved one has been seriously injured by a surgical mesh product, please contact us at 1-877-MessaLaw or visit us at www.messalaw.com.