News & Resources
Transvaginal Mesh Products Are High-Risk Devices According to the FDA
At last, the FDA has finalized its proposals from April of 2014 to reclassify certain transvaginal mesh implant devices from Class II medical devices to Class III devices. Class III medical products are “high risk” devices that require pre-market approval. This is a process that requires manufacturers to provide the FDA with clinical data to demonstrate safety and efficacy of a product before it can be sold. The reclassification only applies to transvaginal mesh used to treat pelvic organ prolapse (POP) and does not include transvaginal mesh sling products implanted for the treatment of stress urinary incontinence.
Companies already selling the vaginal mesh products (Johnson & Johnson/Ethicon, Boston Scientific Corp., C.R. Bard, Inc., etc.) will still have about 2 ½ years to submit their premarket approval applications. Companies making new transvaginal mesh devices for POP repair must submit a premarket approval application before the new products can be sold.
Transvaginal Mesh Injuries
Many women who have been implanted with transvaginal mesh implants have suffered serious injuries, including:
- Extreme Pelvic Pain
- Vaginal Scarring and Deformity
- Erosion/Protrusion of Mesh
- Urinary Problems
- Recurrent Infections
- Painful Sexual Intercourse
In light of these serious injuries, thousands of women have filed lawsuits. By some estimates, more than 70,000 women are actively pursuing lawsuits against the manufacturers of vaginal mesh implants. Our attorneys are helping women in Tampa and throughout Florida determine whether they should file a lawsuit to get compensation for their injuries.
Hiring a Tampa Vaginal Mesh Lawyer
One of the most important factors to consider when choosing a vaginal mesh attorney is how much experience the attorney or law firm has in medical device lawsuits. The companies that manufacture transvaginal mesh devices include, but are not limited to:
- Boston Scientific Corp.
- American Medical Systems
- R. Bard, Inc.
- Johnson & Johnson/Ethicon
These are large pharmaceutical companies that have teams of attorneys attempting to reject responsibility and liability for the injuries they have caused. Having an attorney with the experience to hold multinational corporations responsible is essential if your lawsuit against these companies is going to succeed.
The knowledgeable attorneys at Alley, Clark & Greiwe have the skills and experience to litigate against medical device manufacturers on behalf of women injured by pelvic mesh implants.
Are You Entitled to Compensation After a Mesh Injury?
Only an experienced attorney can determine whether you should pursue a lawsuit. Our attorneys have nearly three decades of experience pursuing pharmaceutical companies and protecting patients.
If you are a woman in the Tampa area who has had a mesh implant and suffered injuries, contact our attorneys immediately for a free initial consultation.
Call us at 813-222-0977 or schedule a free case consultation online.
