Pinnacle & Obtryx Transvaginal Mesh Products Cause Significant Losses
to Boston Scientific Significant
On November 13, 2014, a Miami, Florida Federal court awarded $26.7 million to four women who claimed egregious injuries caused by the Pinnacle mesh implant and accused the company, correctly, according to the court, of defective design and failure to warn physicians and patients of the risks associated with the implant.
A week later, another group of women were awarded $18.5 million by a Charleston, West Virginia court. These women were also inflicted with permanent and severe injuries caused by the Obtryx mesh sling used to treat incontinence. The court upheld the plaintiffs’ complaints of negligence and deliberate deception by Boston Scientific.
In September, a Texas state court rendered a $73 million verdict to one woman for injuries suffered from a Boston Scientific transvaginal mesh implant.
The manufacturer would probably like all cases to be heard in a court much friendlier to their interests, such as the state court of Massachusetts, where the company is based, and where they have won several cases.
FDA Approval and Recall of Transvaginal Mesh Implants
Transvaginal mesh slings were created using the same mesh implant method previously created for hernia surgeries. A pliable, mesh-like product is inserted into a woman’s body to form a sling to support the bladder or uterus, which would also provide assistance in alleviating incontinence. However, instead of requiring manufacturers to apply for a new application for a new product, the FDA allowed the product to ride solely on the backs of other similar products using the 510(k). Thus, since 1996, women have been live test subjects for the transvaginal mesh products.
The sling proved to be rigid, rather than supple, with sharp edges with the capacity to tear into the into the organs and tissues of its host. Furthermore, the mesh embeds itself into the organs and tissue becoming so entwined that it cannot safely be removed, and many of the injuries it causes cannot be reversed.
Since the first approval of the transvaginal mesh implants in 1996, thousands of complaints were reported to the FDA. In 2012, the FDA issued orders to all manufacturers of urogynecologic surgical mesh products to produce studies of the monitored products released and produce the results to the FDA. In response, many companies quietly withdrew their products from the market.
Boston Scientific Plans to Appeal Verdict
As in any large monetary award, Boston Scientific denies liability and plans to appeal the verdicts.
It appears they, as well as many other manufacturers, may have a lot of cases to appeal.
In total, there are almost 70,000 cases against several mesh implant manufacturers in multi-district and state courts all over the country.
- Boston Scientific has 14,250
- Bard Avaulta – 10,117
- Ethicon – 22,077
- American Medical Systems (AMS) – 19,170
- Coloplast – 1,813
- Cook Medical – 293
- Neomedic mesh lawsuits –84
PROFITS OVER SAFETY
Yet, the manufacturers of these proven defective products remain proud and arrogant, convinced that their vast amounts of money hold them immune from the confines of silly things like laws. They continue to put their faith in profits rather than maintaining the safety, health and welfare of patients implanted with their products. Patients can pray that these large monetary verdicts will deter and possibly knock manufacturers from their lofty perches long enough for them to see the pain and suffering their greed causes their consumers.