Faced with growing pressure from the FDA, Ethicon, a division of pharmaceutical giant Johnson & Johnson, recently announced a recall of four vaginal mesh products from its Gynecare line: Prolift Kit, Prolift +M Kit, Prosima Kit, and TVT Secur. The recall is a response to a January, 2012 FDA order that companies producing vaginal mesh products must conduct further studies on the safety and side effects of these devices, as well as a March, 2012 FDA report finding that Johnson & Johnson had initially distributed Prolift products without proper approval.
Vaginal surgical mesh is most common used to treat Pelvic Organ Prolapse (POP), a condition in which internal organs drift into the vagina - sometimes even to the vaginal opening - due to a weakness in the tissues that are supposed to hold the organs in place. In July, 2011, the FDA issued a Safety Communication noting an association between the use of vaginal mesh and a number of severe side effects such as mesh erosion, incontinence, organ perforation, neuro-muscular deficiencies, pain, infection, bleeding, and recurrent POP. These side effects can be both physically and emotionally devastating.
POP is often treated with the permanent insertion of surgical mesh as a means of providing support to the weakened tissue, although the July, 2011 FDA statement concluded that surgical mesh provided no treatment benefits above non-mesh repair. The combination of the high risk of severe side effects and lack of efficacy led the FDA to recommend that vaginal mesh only be used as a last resort treatment option. Sadly, for many women who attempted to treat their POP with vaginal mesh, the damage has already been done.
Women implanted with vaginal mesh who have experienced serious side effects may be entitled to compensation for their injuries. If you have suffered an injury as a result of the use of vaginal mesh,
please contact one of our experienced vaginal mesh attorneys via our
online form or call 888-773-3515 for a free and confidential consultation.