Transvaginal Mesh Injuries - Recent Verdict in New Jersey
Posted on behalf of Goldberg Finnegan, LLC on Mar 01, 2013 in Product Liability
Thousands of women have been treated with transvaginal mesh products since 2002 and many have suffered injuries as a result. These products have been used since about 2002 to treat "Stress Urinary Incontinence" (SUI) and "Pelvic Organ Prolapse", also known as (POP). The trans vaginal mesh procedure was touted as an easier and safer alternative to hysterectomy surgery. Hundreds of thousands of women have had the procedure to treat stress urinary incontinence and pelvic organ prolapse.
Stress Urinary Incontinence is basically when urine leaks during physical activity such as running, coughing, sneezing or laughing). Pelvic Organ Prolapse (POP) is basically when the bladder falls from its normal position in the tummy and pushes against the vaginal walls. This often occurs after childbirth or surgery. Many of those who had the procedure later complained of complications including pain, infection, excessive bleeding; and many had to have follow up surgeries.
The Problems with Transvaginal Mesh
Scientific studies have found that women treated with vaginal mesh have a much higher likelihood of developing bladder perforation, urinary incontinence, and also that many women needed follow-up surgeries to correct these problems. The FDA (with the Center for Devices and Radiological Health) has also recognized the problems and in July 2011 issued a report titled Urogynecologic Surgical Mesh: Update on the Safety and Effectiveness of Transvaginal Placement for Pelvic Organ Prolapse confirming the concerns in the scientific studies. The side effects of transvaginal mesh include the following:
- Mesh Erosion of the vaginal skin
- Pain during sexual intercourse
- Recurrence of Pelvic Organ Prolapse
- Urinary Incontinence (peeing on yourself)
- Internal Bleeding and Infection
FDA Action - Are they part of the problem or part of the solution?
The Food and Drug Administration (FDA) has been monitoring the problem with Transvaginal Mesh. In fact, in 2008 the FDA issued an alert to tell patients and doctors that ladies with vaginal mesh were suffering a high rate of complications. From January 2008 to December 2010, there were nearly 3,000 reports of injuries and/or death linked to transvaginal mesh used for pelvic organ prolapse (POP) or Stress Urinary Incontinence (SUI).
What is now clear is that transvaginal mesh was not properly tested before it was sold to consumers. The various manufacturers knew that the mesh product was very good at treating hernias, and therefore assumed that it would also be an excellent product when surgically placed in the vagina. The manufacturers pushed the product through the FDA's expedited 510(k) approval process which does not require testing since the mesh was similar to the mesh used to treat hernias. This presumption has proven wrong, and as a result of transvaginal mesh manufacturers rush to get their product to the market, literally thousands of women have suffered life altering injuries. The FDA issued an Updated Alert in July 2011 in which it states
"Based on an updated analysis of adverse event reports reported to the FDA and complications described in the scientific literature, the FDA identified surgical mesh for transvaginal repair of POP as an area of continuing serious concern...The FDA is issuing this update to inform you that serious complications associated with surgical mesh for transvaginal repairs of POP are not rare."
February 2013 - First Jury Verdict in Vaginal Mesh Case
The first Vaginal Mesh Lawsuit went to trial in New Jersey and the jury returned a verdict on February 25, 2013 of compensatory damages in the amount of $3.35 Million Dollars in compensatory damages against Johnson & Johnson, and $7.76 million in punitive damages for a total vaginal mesh verdict of $11.11 Million Dollars.
While our firm did not handle this particular case, the verdict is important because it provides insight as to the potential value of vaginal mesh cases. Of course every case is different and the outcome in one case does not guarantee the outcome in any other case. That said, there are over 1,800 other vaginal mesh lawsuits pending throughout the USA and I am sure that vaginal mesh manufacturers such as Johnson and Johnson, C.R. Bard, Mentor, Boston Scientific, Gynecare, Tyco, Covidien, and American Medical Systems will have to take this large verdict into consideration as the decide whether to litigate or settle future transvaginal mesh lawsuits.
The case involved a 47 year old lady from South Dakota who had a transvaginal mesh product called Ethicon Gynecare Prolift. The jury found that Ethicon failed to warn the patient's surgeon of the risks associated with Pro-lift vaginal mesh and that the defendant also improperly marketed the device.