We have written in prior issues about all of the heartbreaking problems women across the U.S. are having because of the transvaginal implantation of polypropylene mesh to correct pelvic organ prolapse or stress urinary incontinence. As we have reported, the mesh is used to repair pelvic organ prolapse, or when muscles in the area weaken, causing organs to bulge or slip down into the vagina. Pelvic organ prolapse can be the result of age, childbirth, obesity, or hysterectomy. Mesh is also implanted transvaginally to treat stress urinary incontinence, which occurs when a woman experiences involuntary leakage of urine during exercise, coughing, or laughing. The Food and Drug Administration has warned that women can suffer complications, stating that in the case of pelvic organ prolapse all other alternatives should be explored prior to a decision to have a transvaginal mesh procedure. Based on all we have learned, I don’t believe transvaginal mesh should be used at all by doctors.
There are more than 14,000 federal lawsuits against some of the largest manufacturers of transvaginal mesh products. The cases have been consolidated in a federal court in West Virginia. More trials are upcoming – against Bard in June and American Medical Systems in December. These lawsuits accuse the companies of inadequate testing, failing to disclose potential risks, and fraudulently promoting the mesh as a safe medical device. The manufacturers deny those allegations, but they will have difficulty proving a defense to their actions and failures to act, based on what we have learned during discovery. The lawsuits seek compensation for pain and suffering, reimbursement of medical costs and punitive damages.
When pelvic mesh products were introduced, they were seen as an improvement over traditional surgery using stitches and a woman’s own body tissue, which also can have complications. Transvaginal mesh procedures were portrayed as more effective and having a much shorter recovery period. Since similar mesh was already used in other types of surgery, including for repairing hernias as far back as the 1950s, the products received fast-track approval from the FDA without the tests that the agency requires for first-of-a-kind devices.
The FDA cleared the mesh — often a soft, lightweight porous plastic — for pelvic organ prolapse in 2002. The agency said in a 2008 public notice that problems were “rare.” But in July 2011, the FDA admitted that it erred in its initial assessment and estimated the most common problems occur in 10% of women within a year of surgery. The mesh can be inserted through the vagina or through an incision in the abdomen. The problems involve shifting and erosion of the mesh, as well as infections. A year ago, the FDA ordered several dozen manufacturers to conduct rigorous studies to track the complication rates with their surgical mesh products over time. Some companies have undertaken those studies, while others chose to stop producing certain products.
The mesh manufacturers have a responsibility to educate doctors about their products, but they failed to do so. Doctors were not aware of the very serious problems caused by transvaginal mesh or the rate at which those problems were occurring. Rather than doctors being the problem, the real culprit is the mesh product itself. Lawyers in our firm don’t sue doctors in these cases and we believe that is the proper course of action. Doctors have been victims themselves.
Most transvaginal mesh cases have been consolidated in the United States District Court for the Southern District of West Virginia before Judge Goodwin. However, several thousand lawsuits have also been filed in state courts around the country. In the first lawsuit of this type to go to trial, a California jury in July awarded a California woman $5.5 million in her case against C.R. Bard. Then the verdict in New Jersey following. These are two very big victories for all women who have been victimized by the manufacturers.
Our firm is heavily involved in the mesh litigation. If you have questions or need more information, contact Leigh O’Dell, a lawyer in our Mass Torts Section who handles this litigation for the firm, at 800-898-2034 or by email at Leigh.Odell@beasleyallen.com.
Source: Associated Press and ABC News
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