A lawsuit was filed on November 5, 2012 in the Northern District of California (Oakland) against C.L Medical over complications from I-STOP Vaginal Mesh. The lawsuit was filed by a woman plaintiff from California in which she alleged that she suffered permanent injuries from an I-STOP vaginal mesh implant that she received few years back.

In the lawsuit filed by the Californian woman and her husband it was said that the plaintiff was implanted with the vaginal mesh implant on September 14, 2010, after she was diagnosed with stress urinary incontinence and pelvic organ prolapse. However, immediately after the implant she began experiencing some side effects and the prolonged use of the drug forced her to undergo two revision surgeries.

According to the lawsuit filed by the plaintiff and her injury lawyer the side effects include bleeding, infections, chronic pain, mesh erosion, and hardening of the mesh. With the lawsuit the plaintiff has brought multiple counts against the defendant including strict liability, negligence, breach of implied warranty and fraudulent concealment. The plaintiff has claimed for compensatory and punitive damages for the physical injuries and mental distress that she suffered all the way through.

The personal injury lawyer of the plaintiff claimed that the vaginal mesh implant I-STOP contains non- compatible components like polypropylene that elicit a negative immune response in the body. The vaginal mesh attorney opined that this was one of the major causes of high failure rate of the implant. Side-effects and complications that the plaintiff suffered during the period includes nerve damage, tissue degradation and mesh erosion. The plaintiff has alleged the defendant that despite the high failure rate of the device the company promoted it aggressively neglecting the consequences that it could lead.

What are Vaginal Mesh Implants?

A Vaginal Mesh Implant also known as Trans Vaginal Mesh Implant is a medical device made up of porous synthetic material to repair damaged or weakened tissue that are caused by pelvic organ prolapsed or stress urinary incontinence. The device was introduced in the market in the year of 1990. The device was introduced with the intention to fix problems like pelvic organ prolapsed (POP) that are experienced by older women after their childbirth. The problem arises when the pelvic muscles of women weaken and the pelvic organ like bladder; uterus and rectum get dropped into the vagina.

According to reports from various sources around 50% of women in theUnited Statessomehow experience pelvic organ prolapsed however only a few of them require vaginal mesh surgery. A vaginal mesh implant can also be used to reduce the size of the neck of urinary bladder to treat urinary incontinence which occurs when women jump, cough, laugh or sneeze.

Side Effects of Vaginal Mesh Implants

Vaginal mesh implants

that are commonly used to treat hernia and Pelvic Organ Prolapses was approved by the United Stated Food & Drug Administration in the 1990’s and since then it has been widely used in United States. In the late 90s, the device was also found effective in treating Stress Urinary Incontinence which is also known as SUI.

However, later on complaints began to come out pertaining to its high failure rate and other side effects. Some of the side effects of vaginal mesh implants that are common these days are:

  • Organ Perforation
  • Infections
  • Inflammation
  • Vaginal Mesh Erosion
  • Scarring
  • Urinary Problems
  • Fistula