Vaginal Surgical Mesh and Severe Side Effects

Vaginal Surgical Mesh and Severe Side Effects

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

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

Pelvic mesh, also known as transvaginal mesh, is mesh that is surgically placed for the treatment of women’s gynecological and urogynecological issues such as pelvic organ prolapse or stress urinary incontinence. Pelvic mesh is made of synthetic material, usually polypropylene, and is made of porous or micro porous weave. Some products even claim to have a “biologic element” made of a collagen blend.

Surgical mesh has been used in gynecology since the 1990’s. By using the FDA’s 510(k) expedited approval process, the mesh industry would produce dozens of these products each year without having to prove the safety or efficacy of these devices. In 2004, the industry began producing “pelvic organ prolapse kits” under the premise that these products were a safe and effective alternative to proven traditional surgical techniques.

Pelvic Organ Prolapse is the downward descent of the pelvic organs, usually after childbirth. Statistics show that pelvic organ prolapse affects approximately 50% of women who have given birth. Many treatments are available to treat pelvic organ prolapse, including surgical repair. Traditional surgical repairs are available to physicians and surgeons, either through Colporrhaphy (use of native tissue and sutures) or Sacrocolpopexy (laparoscopic surgery). Since the inception of mesh prolapse kits in 2004, doctors have increasingly turned to pelvic mesh over traditional surgery due to the false premise created by the mesh industry that mesh is a better alternative.

In 2010, it is estimated that 100,000 pelvic organ prolapse procedures were performed using pelvic mesh.

In July 2011, the FDA issued heightened warnings regarding the use of transvaginal mesh for the repair of pelvic organ prolapse. Three months later, in September, 2011, an FDA panel recommended that pelvic organ prolapse mesh be reclassified to prevent any more clearance of these products through the 510(k) expedited clearance process.

Pelvic mesh is used to treat pelvic organ prolapse conditions known as:

  • Cystocele
  • Rectocele
  • Enterocele
  • Vaginal Vault Prolapse
  • Procidentia

If you received a mesh product during a surgery to repair pelvic organ prolapse, that product could be responsible for serious complications such as:

  • Mesh erosion
  • Pain
  • Bleeding
  • Mesh-related infections
  • Pain during sexual intercourse (dyspareunia)
  • Vaginal scarring or shrinkage

Resources