An award of $5.5 million has been made in the first trial over a transvaginal mesh lawsuit. The jury found against medical device maker, C.R. Bard, and its Avaulta Plus transvaginal mesh. The jury agreed that Bard’s Avaulta Plus transvaginal mesh caused numerous and painful injuries in a California woman. The woman received the mesh to treat pelvic organ prolapse (POP), said Mass Device.
Christine Scott received $5 million for her injuries; her husband was awarded an additional $500,000 for damage to their intimate life. According to Scott, she was implanted with two Avaulta Plus surgical devices; the devices remain in her body and are unable to be removed safely, said MassDevice. This has led to eight more surgeries and nine other procedures to correct the damage caused. Scott’s lawsuit was filed in 2009 to treat her occasional urinary incontinence. The surgery has left her completely incontinent, in constant pain, and unable to have sexual relations, said MassDevice.
As we’ve explained, transvaginal mesh devices were approved through the U.S. Food & Drug Administration’s (FDA) 510(k) “fast-track” approval system in which little or no comprehensive pre-market safety testing is required, which is based on the theory that the fast-tracked products are similar in design to other, approved surgical products. While mesh devices have been used in surgery before, they were never used in this application and the results of this haphazard approach have been disastrous for thousands of women. Transvaginal mesh devices are prone to erode through skin and the vaginal wall and have been known to cause extrusion, perforation, and abscess. They can also break apart, making surgery to remove the defective device even more dangerous, painful, costly, and complex. Pain, inflammation, and the risk of infection present themselves to women who suffer from the dangerous effects of these devices.
The settlement might not bode well for Johnson & Johnson, Endo Pharmaceuticals Holdings, and Boston Scientific. As MassDevice pointed out, the jury decision may impact other decisions to these device makers, as well as Bard, all of which are in the midst of similar lawsuits.
Although Bard did pull it mesh products from the U.S. market earlier this month, it plans on appealing Scott’s decision, saying that its products can be used “safely and effectively when used properly and when used with the right patient,” according to a Bard attorney, wrote MassDevice. The Avaulta continues to be marketed outside of the U.S.
Also last month, Johnson & Johnson pulled its mesh products after more than 600 women filed personal injury lawsuits blaming the implants. According to Johnson & Johnson, the decision did not involve safety or efficacy issues; the company did not issue any warnings to woman who had already received the implants, said MassDevice.
Last July, the FDA warned patients and physicians that surgical placement of mesh to repair POP may expose patients to unnecessary risk and no clear clinical benefits appears to exist over other, safer alternatives, said MassDevice. “There are clear risks associated with the transvaginal placement of mesh to treat POP,” FDA devices deputy director Dr. William Maisel said then. “The FDA is asking surgeons to carefully consider all other treatment options and to make sure that their patients are fully informed of potential complications from surgical mesh.”
In late 2011, three U.S. Senators implemented a probe on Bard and its management concerning its transvaginal mesh devices, which was part of a larger investigation into medical device recalls. Early this year the FDA asked 33 mesh makers to conduct safety and efficacy trials for three years, to collect and review existing data on the devices’ safety and efficacy; and to conduct 88 post-market surveillance studies, said MassDevice.
Meanwhile, we recently wrote that a Tennessee woman filed a lawsuit against Boston Scientific over its Advantage Transvaginal Mid-Urethral Sling System. The national law firm, Parker Waichman LLP, filed the lawsuit on behalf of the patient who received the mesh to treat her POP and stress urinary incontinence (SUI), but suffered from an array of adverse effects. Parker Waichman LLP represents numerous women who have fallen victim to the defects of transvaginal mesh devices. Each lawsuit shares similar complaints; that these and other transvaginal mesh devices were not properly tested before being used in surgery.