Vaginal Mesh Lawsuits On the Rise
Vaginal Mesh Lawsuits
Transvaginal mesh manufacturers are facing an increasing number of negligence lawsuits, calling into question the Food and Drug Administration’s approval process for such devices.
To date, at least 600 lawsuits have been filed against vaginal mesh manufacturers seeking compensation for injuries sustained as a result of transvaginal mesh complications.
The vaginal mesh was originally developed to help women who had difficulty with incontinence or pelvic organ prolapse, brought on by a weakening of the pelvic floor muscles. These conditions may occur as a result of childbirth, menopause or a reproductive surgery, such as a hysterectomy. The mesh is implanted through a surgical procedure in which the synthetic material is positioned over the patient’s pelvic floor muscles and then sutured into place. Removing the mesh can be extremely difficult as the material is essentially absorbed by the surrounding tissue.
While the transvaginal mesh is intended to help women, these devices may actually be causing further injury. Researchers have pointed out the mesh can actually erode into the vagina, slip out of position or shrink, resulting in difficulty urinating, pelvic pain, serious infection and extreme discomfort during sex. These devices can also potentially cause perforation of the bladder, bowel or adjacent blood vessels, nerve damage, and vaginal scarring. Some of the lawsuits filed allege that the vaginal mesh side effects have caused life-threatening complications.
Current vaginal mesh models and FDA rules
Current vaginal mesh models were approved under the FDA’s 510(k) rule. This rule allows a product to be released to the market with little or no patient testing if a similar product was already approved through the FDA testing process. Under the 510(k) rule, tens of thousands of defective heart defibrillators and artificial hips were also released to the market, resulting in serious complications. These devices have since been recalled.
The Johnson & Johnson Company continues to stand by the quality of their transvaginal mesh products. The company manufactures the Gynecare TVT, which is modeled on an earlier device called the ProteGen, which has since been recalled from the market. Johnson & Johnson asserts that the safety and efficacy of its vaginal mesh device are supported by 13 years of clinical research data.
The FDA is considering making changes to the 510(k) rule, however, products continue to be approved under this system. According to the FDA, 300,000 women received transvaginal mesh implants in 2010 alone, potentially opening the door for even more personal injury lawsuits.
If you or someone you love has experienced serious or life-threatening side effects after undergoing transvaginal mesh implant surgery, you need to speak with a qualified medical device attorney right away to protect your rights. You may be entitled to damages for your medical bills, lost wages and pain and suffering caused by the defective transvaginal mesh.
Contact us today at 1-800-722-0765 to speak with one of our personal injury experts. Your initial case evaluation is absolutely free and we charge no fee unless we win a judgment on your behalf. Call us today to find out how we can help with your transvaginal mesh side effects lawsuit.