AMS Begins First of Two Transvaginal Mesh Safety Studies
According to MarketWatch.com, medical device manufacturer American Medical Systems has launched a transvaginal mesh safety study to determine whether two of its transvaginal mesh products have caused pain during sexual intercourse, chronic pain and other complications as plaintiffs claim in thousands of U.S. transvaginal mesh lawsuits.
AMS announced on June 9, 2014 that the first patient had been enrolled in its Embrace study, which will involve the AMS Atypical Prolapse Repair System and the Elevate Anterior. The decision to launch transvaginal mesh safety studies stems from an order from the U.S. Food and Drug Administration that requires all transvaginal mesh manufacturers to conduct post-market surveillance studies to test the companies’ products for risks versus benefits. According to the FDA, the agency received more than 1,000 reports from nine transvaginal mesh manufacturers of complications that were associated with use of the implants to repair stress urinary incontinence and pelvic organ prolapse.
The Co-Chief of Urogynecology and Pelvic Reconstructive Surgery at the Stanford University School of Medicine will lead the Embrace Research, comparing both devices with a native tissue repair control group. He states that pelvic organ prolapse is complex, often requiring multiple treatments to address the exact nature of the prolapse. In particular circumstances, a transvaginal mesh implant may be appropriate and beneficial.
AMS Transvaginal Mesh Safety Studies to Be Completed in Five Years
The Embrace study is one of the largest ever conducted by AMS, according to MarketWatch.com, and is the largest involving its Atypical Prolapse Repair System and Elevate Anterior. According to the article, 494 patients are expected to roll in the study at 40 locations across the country. Additionally, AMS is planning to conduct research involving its Elevate Posterior products, a study that will be referred to as the Harmony and will also involve 494 patients at 40 locations throughout the U.S.
AMS maintains that each of its transvaginal mesh safety studies will involve a two-year enrollment period after which the study will continue for three additional years. Both studies are expected to reach completion after five years, making them significantly longer than other post-market trials involving the transvaginal mesh implants.
Plaintiffs Allege Complications, Injuries
According to plaintiffs who have been fitted with transvaginal mesh implants like those manufactured by AMS, the products may cause serious and life-threatening complications such as:
- Infections in the mesh area
- Local organ damage
- Mesh site bleeding
- Urinary tract issues
The most common complication noted by transvaginal mesh recipients is that of mesh erosion, however, which involves the growing of skin around the implant. Should this occur, the woman will likely be required to undergo surgery to remove the implant from her body. However, in some cases, the mesh has grown attached to the body, and women are placed at an increased risk of needing a hysterectomy to rid their bodies of the implant.
Have You Been Injured by Transvaginal Mesh? Bernstein Liebhard LLP Can Help
If you received a transvaginal mesh implant from American Medical Systems and you are experiencing complications, you may have legal recourse. The attorneys at Bernstein Liebhard LLP are currently providing free case evaluations to transvaginal mesh recipients who have alleged suffered injuries due to several manufacturers’ products. Call us now at (888) 217-3033 to learn more about how transvaginal mesh safety studies can help hip recipients and how you may be entitled to recover compensation for your injuries.