The United States Food and Drug Administration (FDA) has ordered manufacturers of the controversial transvaginal mesh implants, a total of 33 companies, to conduct three years of safety and effectiveness trials on the devices, according to Massdevice.com. This move follows growing public pressure and concern over the potential harm caused by these implants, and also comes after numerous multi-district lawsuits, FDA panel meetings, and citizens’ petitions incited by a July 2011 warning that the surgical mesh may pose an unnecessary risk to women. The FDA is officially asking manufacturers of the implants, including Johnson & Johnson and C.R. Bard, to collect and review any existing data on the efficacy of their devices and mandated 88 postmarket surveillance studies between the 33 companies.
Transvaginal mesh is used to treat pelvic organ prolapse, and from 2008 to 2010, the FDA received 1,503 adverse reports associated with the transvaginal mesh used to repair this condition. A number of medical device manufacturers have introduced the gynecological surgical mesh, but unfortunately, not all were thoroughly tested for complications before being placed on the market. Some of the health problems patients have experienced related to the medical mesh include:
- Vaginal infections;
- Difficult bowel movements;
- Bleeding;
- Erosion of the implanted mesh;
- Recurrence of dropped or prolapsed organs;
- Lower backaches; and
- Leakage of urine.
Any medical device manufacturing company has the responsibility to fully test a product before putting it on the market; otherwise, dangerous complications and threats to a patient’s health and well-being can result. The transvaginal surgical mesh attorneys in Tennessee with Massey & Associates, P.C. can help any woman who has experienced health problems due to the implant receive compensation for her injuries and pain and suffering. We will work diligently to ensure any at-fault parties are held legally accountable. Call (423) 396-0720 for a complimentary consultation.
Gary Massey, Jr., is a well-known courtroom advocate practicing law in Chattanooga, Tennessee. Gary is a native of Tennessee who began practicing law in 1998. He graduated from Cumberland School of Law where he was ranked in the top 3% of his class and was an editor of the Cumberland Law Review.
