Transvaginal Surgical Mesh

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) 697-4529 for a complimentary consultation.

Pelvic organ prolapse (POP) is a condition in which one or more of the organs in the pelvic region move out of place because the tissues designed to keep them where they belong become too weak to do the job. POP is common in women, especially those who have had hysterectomies or pregnancies. Treatment of POP often involves surgery, and in recent years, some POP surgeries have tried to treat the condition by inserting a surgical mesh into the pelvis.

The surgical mesh used to treat pelvic organ prolapse and stress urinary incontinence (SUI) is a sterile medical device that is added as a strengthening layer to pelvic tissue. It is intended to help the body keep the pelvic organs in their proper place. However, since 2008, the U.S. Food and Drug Administration (FDA) has received over 2,500 complaints from patients who have had medical problems after having a surgical mesh inserted to treat POP or SUI.

Symptoms of transvaginal surgical mesh complications include erosion of the surrounding tissue, infections, pain, urinary problems, and recurrence of the symptoms the mesh was intended to treat, according to the FDA. Some patients have suffered tearing in the bowel, bladder, or pelvic blood vessels when the mesh was inserted. Many patients have developed scar tissue in the area surrounding the mesh, which can cause chronic pain, pain or difficulty urinating, or pain during sexual activity.

If you or someone you love has suffered symptoms related to transvaginal mesh complications, the skilled Tennessee transvaginal surgical mesh injury attorneys at Massey & Associates, P.C. can help you protect your legal rights and fight for any compensation you may deserve. For a free and confidential consultation, call us today at (423) 697-4529.

Pelvic organ prolapse (POP) occurs when the pelvic organs slip out of place after the tissues that hold them in place start to weaken. This condition is most often seen in women who have had a hysterectomy or other abdominal or pelvic surgery that involved removing organs or muscle tissue. One way physicians treat POP is by inserting a surgical mesh to support the prolapsed organs.

Recently, however, the U.S. Food and Drug Administration (FDA) released a statement urging caution in the use of surgical mesh to treat pelvic organ prolapse. The FDA noted that complications caused by the mesh are not as “rare” as previously thought, and that data collected from patients who have had the mesh inserted indicates that it does not treat POP more effectively than surgeries that don’t use the mesh; however, the risk of complications is higher. The FDA received nearly 3,000 complaints of complications related to surgical mesh between 2008 and 2010.

The FDA recommends additional studies on the safety and efficacy of transvaginal mesh insertions to treat pelvic organ prolapse or some kinds of incontinence. Meanwhile, the agency recommends that physicians seek other, non-mesh-using methods to treat these conditions.

If you or someone you love has suffered complications after receiving a surgical mesh, please don’t hesitate to contact an experienced Chattanooga transvaginal surgical mesh lawyer at Massey & Associates, P.C. For a free and confidential consultation, call us today at (423) 697-4529.