Transvaginal Mesh Devices Prove Unsafe Despite FDA Approval
Products qualifying as medical devices are required to undergo a rigorous review by the Food and Drug Administration (FDA) before being sold. However, some medical devices marketed in the past, or currently promoted, pose dangers to patients because of poor testing and flawed FDA review. Transvaginal mesh (TVM) slings are among the defective products the FDA is still approving for sale and use. Patients injured by TVMs may have cause to sue medical device manufacturers and physicians because of the FDA’s continued carelessness.
TVM Devices Defined
Typically made of propylene mesh, TVM devices are used to treat conditions like pelvic organ prolapse (POP) and stress urinary incontinence (SUI). The TVM slings are inserted in the vaginal area to help repair weakened or damaged tissue, including the falling down or slipping out of place of organs or tissue like the uterus, vagina or bladder and the inability to control the flow of urine. TVM devices are also called mesh patches, mesh kits and transoperative or vaginal tape and are commonly used in pelvic reconstruction surgeries.
Potential For Harm
According to the FDA, there were more than 1,000 reports of adverse events involving TVMs from 2005 to 2007. Poor TVM reports increased between 2008 and 2010, with the FDA logging around 2,900 cases. About 1,500 were for complications with POP repairs and 1,400 were for issues after SUI surgeries. The FDA recently reviewed scientific reports from 1996 to 2011 to assess how safe and effective the use of TVMs are in POP and SUI procedures. The FDA concluded that TVMs do not “improve symptomatic results or quality of life” compared to non-mesh methods following POP repairs, but it is still interpreting SUI data.
Common TVM Injuries
The FDA stated the most common TVM reports it received between 2008 and 2010 were for general pain, infection and bleeding, as well as erosion or contraction of the mesh through the vagina. Issues with urination, pain during intercourse and the perforation of nearby organs also occurred. Other reported problems with TVMs included conditions that needed further medical treatment like continued prolapse, vaginal scarring or shrinkage, neuro-muscular difficulties and hormonal or emotional issues. No single TVM brand is to blame.
Claims Available To Injured Victims
The FDA acknowledges, and people seem to agree, that TVMs present further risks and complications to correct POP and SUI-related conditions than non-mesh methods. TVMs can also cause even further damage than the initial weakened or damaged tissue and, in some cases, lead to a patient’s death. TVM makers like Johnson & Johnson, Boston Scientific and American Medical Systems Holdings Inc. continue to face lawsuits brought by patients who were implanted with these defective devices and not properly informed of their risks.
If you or your loved one recently underwent surgery for POP or SUI and any brand of a TVM device was implanted, contact a local attorney with experience in product defects and personal injury litigation. You may be able to sue the TVM manufacturer for compensatory and punitive damages, pain and suffering, medical expenses, lost wages or wrongful death.