As any mother can tell you, pregnancy and childbirth take a toll on women’s bodies. During a vaginal childbirth, stress is placed on the muscles and tissue that make up the pelvic floor and support the internal organs of a woman’s pelvis. Sometimes those muscles and tissue become stretched or even tear, particularly after multiple vaginal births. One of the symptoms of this fatigue is a condition called stress urinary incontinence (SUI), which can cause leakage of small amounts of urine during physical activities that increase abdominal pressure. As women age, those weakened muscles and tissue sometimes fail, causing the uterus, bladder, or rectum to push painfully against the vaginal wall, resulting in potentially severe discomfort or other health issues. This condition is called pelvic organ prolapse (POP), and in some cases it can dramatically affect a woman’s quality of life and overall health. An estimated 1 in 9 women will require some sort of procedure to repair a POP-related condition during their lifetime. Beginning in the 1970s, surgeons began using surgical mesh products made from metal or plastic to conduct surgical repair procedures on women suffering from POP. Surgical mesh had long been used to repair abdominal hernias, and adapting it to repair POP damage was a seemingly logical step. By the 1990s, the use of surgical mesh had broadened enough that women suffering from severe SUI also were undergoing mesh procedures. It wasn’t until 1996 and 2002, however, that the FDA approved the first mesh products specifically designed to treat SUI and POP, respectively. As these new mesh products evolved in the marketplace, surgical implantation was increasingly avoided in favor of transvaginal placement: the doctor performing the procedure could insert the mesh product directly into the vagina to reinforce the vaginal wall and help prevent the pelvic organs from impinging upon it. The procedures seemingly became less invasive, more accessible, and less traumatic for the patients. At least, that was the idea. As the use of transvaginal mesh products increased, alarm bells started to sound at the federal government’s Food and Drug Administration (FDA). From 2005 through 2010, the agency became aware of almost 4,000 cases where transvaginal mesh was associated with malfunction, injury, or death. There were reports of implanted mesh eroding vaginal tissue, causing severe urinary tract infections, causing bleeding, triggering neuromuscular problems, even causing organ perforation. Between 2008 and 2010, three women died in connection with transvaginal mesh procedures to treat POP. Two of them suffered perforations of their bowels. The other hemorrhaged to death. Women who suffered symptoms sometimes had to undergo multiple surgical procedures to remove the faulty mesh, only to discover that the health problems introduced by the mesh lingered or even worsened after its excision. After issuing public health notifications about the dangers of vaginal mesh in 2008 and again in 2011, the FDA is belatedly preparing to reclassify all surgical mesh products that are inserted into the vagina to treat POP and SUI as Class III, or high-risk, devices. This would require their manufacturers to conduct clinical testing and provide data proving that the devices were safe for distribution to the patient population. Unbelievably, no such safety testing for vaginal mesh devices has ever previously been conducted under regulatory requirements. In the meantime, more than a quarter-million women continue to have transvaginal mesh procedures every year, even though the FDA’s own study concluded more than three years ago that transvaginal mesh provides no improved clinical benefit for treating POP over the traditional surgical mesh procedures that it was meant to replace. Even if the FDA does reclassify vaginal mesh to require clinical testing from its manufacturers, the damage may already have been done to millions of women who have had mesh devices implanted in their bodies over the past 15 years or more. The scale of the suffering caused by these untested, unregulated medical devices is just beginning to take shape. As the realization has dawned on health officials and consumers that the responsible medical device manufacturers prioritized profits over patent safety, almost 100,000 individual lawsuits have been filed against various manufacturers of transvaginal mesh kits.If you’re a woman who trusted your health to a transvaginal mesh procedure and has suffered medical problems as a result, Scartelli Olszewski stands ready to assist you. Our Pennsylvania personal injury lawyers have the knowledge and resources to take on the manufacturers of these defective medical devices in order to compensate those who have been hurt. Call us today.
Rachel D. Olszewski, an attorney at Scartelli Olszewski, P.C., is a dedicated advocate for clients who have suffered unjust harm. Following the legacy of her esteemed family members, Rachel specializes in personal injury, medical malpractice, and criminal defense. She is actively involved in professional associations and serves on the board of the Luzerne County Bar Association Charitable Foundation. Rachel is admitted to practice in Pennsylvania state courts and the U.S. District Court for the Middle District of Pennsylvania.
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