Transvaginal Mesh Medical Device Gains FDA’s High Risk Classification

Twitter ButtonGoogle+ ButtonFacebook ButtonPinterest Button

At first glance, transvaginal mesh treatments appear to be a really good idea. They’re designed to help women who suffer from serious medical conditions such as pelvic prolapses, bladder prolapse, and stress incontinence resume normal lives. When a doctor and their patient agree that transvaginal mesh is a good health option, the surgical mesh is surgically implanted.

transvaginal-lawsuit
The problem that thousands of women all over the United States have discovered is that not only does the transvaginal mesh not always work the way it’s supposed to, but it can also lead some severe health problems which can include:
• Severe pelvic and/or vaginal pain
• Inability to have intercourse
• Organ perforation
• Vaginal shrinkage
• Infection
• Bleeding
• Neuro-muscular problems
The severity of the side effects, as well as the fact that most women feel that the manufactures didn’t provide enough warning about the potential side effects, has prompted the filing of thousands of transvaginal mesh lawsuits throughout the country, including one that ended when a Texas jury ordered, Johnson and Johnson, one of the companies responsible for manufacturing transvaginal mesh to pay a $1.2 million lawsuit to one woman who put her faith in the device.
shutterstock_93505333-1-260x174In this particular case, the transvaginal mesh started to erode after it was in place, leading to a wide variety of serious medical side effects. After hearing the details of her case, the Texas jury agreed and Johnson and Johnson was ordered to pay the settlement.
Another transvaginal mesh was filed against another of the manufacturing companies responsible for creating the mesh, Boston Scientific. That particular lawsuit focuses on the manufactures ethics and business practices, accusing them of using “counterfeit materials from China” and that as a result of the low quality materials, the mesh doesn’t work as well as it should. If a jury agrees with the accusations brought forth in this class action lawsuit, Boston Scientific might not just have to pay a substantial settlement, they could also find themselves dealing with criminal charges.
Boston Scientific, which has been named in approximately 30,000 different lawsuits, has been quick to dispute the negative accusation, stating that “Patient safety is of the utmost importance, and we dedicate significant resources to deliver safe, high-quality products. We don’t believe the case has merit and intend to vigorously defend these claims.”
Courts report that there are approximately 70,000 women in the United States with a transvaginal mesh, many of these have very valid grounds to file a transvaginal mesh lawsuit and use the settlement to help restore their life after it has been ripped apart by unexpected side effects. The fact that the FDA has issued the companies responsible for manufacturing the mesh devices with several warnings and reclassified the transvaginal mesh as a high risk device indicates that it won’t be long before a fresh wave of lawsuits reaches civil courts throughout the United States.

1455717851_saqqiz
If you suspect that your transvaginal mesh as created some harmful  drug side effects, you need to contact a law firm right away and discuss your legal options. The longer you delay, the greater the odds that the statute of limitations, which is quite short in some states, will expire.

Leave a Reply