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Transvaginal Mesh Lawsuit
A transvaginal mesh is a medical implantation device that is intended to correct pelvic organ prolapse (POP) or stress urinary incontinence (SUI), conditions commonly occurring in women following menopause, giving birth, or a hysterectomy. This mesh-like device is typically made of polypropylene (a type of plastic) and is inserted through the vagina (trans-vaginally), though it is possible to insert it abdominally as well. Since the introduction of such meshes in the 1990’s, reports of their failing and causing significant discomfort and serious medical complications to the women using them have surfaced. It is only more recently, however, that the FDA has taken major steps to address the issue, and tens of thousands of lawsuits are now pending nationwide against the various manufacturers of transvaginal meshes.
POP and SUI May Be Better Treated By Other Means
Pelvic organ prolapse involves when a pelvic-area organ such as the bladder, urethra, or uterus, drops down out of its normal position and presses up against the vaginal walls, causing serious pain and irritation. By the age of 80, it is estimated that 10 percent of women will have surgery to correct some form of POP, but it can be treated effectively without a vaginal mesh by methods much less risk-laden.
Stress urinary incontinence involves abnormal urine release when pressure is put upon the abdominal region during exercises, cough attacks, sneezing, or laughter. SUI is more prevalent among women than any other kind of urinary incontinence. It develops when weakness of pelvis-supporting tissues lets the long neck of the bladder descend during physical activities and trigger urine release. In other cases, the problem is that a weak sphincter muscle is no longer able to properly regulate the discharge of urine. Though non-surgical treatment cures many instances of SUI, even those cases requiring surgery need not involve the implantation of a transvaginal mesh, for stitches and other lower risk options are available.
Some women who have a transvaginal mesh already installed and have not experienced any complications may be safe since only a portion (it appears some 10 percent) of meshes have been found faulty. One who already has a mesh should contact her physician to discuss the situation, but since placement of the mesh is essentially permanent without other risky and painful surgery, it would be a major move to attempt to remove it. But if you have been injured or think you have been injured by one of these devices, it is imperative that you quickly seek medical help and contact a good attorney who has experience in handling these cases.
The Problems Caused by Transvaginal Meshes
On October 20, 2008, the FDA warned of the dangers of transvaginal meshes to women in a Public Health Notification and advised doctors to make their patients fully aware that the implantation of such a mesh is essentially permanent and that ensuing mesh-caused medical issues could lead to new future surgeries. They also warned that such corrective surgery would not necessarily be successful. This came in response to a growing tide of complaints about the ill effects that transvaginal meshes were having on approximately one in every ten users. These side effects included: pelvic or vaginal pain, especially during sex, vaginal tissue scarring, the vaginal wall becoming more narrow, bleeding, inflammation, urinary discharge problems, mesh erosion, and the return of the POP or SUI the mesh was supposed to cure. The over 4,000 injury cases that flooded the courtrooms between 2005 and 2010 forced the FDA’s belated action, and at this point in time, the number of lawsuits has swelled to incredible proportions. These meshes are now widely recognized as potentially dangerous. Therefore there is no reason to hesitate in taking legal action if you have suffered injury by a transvaginal mesh implant- the defectiveness of the product is now no secret and settlements are very much obtainable.
The Public Endangerment Factor
In 1996, when the first transvaginal mesh was approved by the FDA, it was done via a process that does not require a thorough product test to be conducted by the manufacturer. In only three years’ time, this initial mesh device was recalled due to a huge number of reported injuries, and yet not only did transvaginal meshes retain FDA approval but a new slew of meshes were introduced to the marketplace by multiple companies who also enjoyed the low-threshold product safety testing requirements of the 1996 recalled mesh. No adequate warnings or appropriate information was included on their products’ packaging to alert consumers of the permanently detrimental effects that could possibly result.
Physical, emotional, and financial losses were sustained by thousands due to this poorly labeled and too-often malfunctioning medical device, and many cases are being won by these victims every year. The allegations in such cases stipulate that there existed a legal and moral responsibility of transvaginal mesh companies to do all possible to ensure the safety and reliability of their products but that this was not done. Instead, the information provided the users is alleged to have been misleading as was the information provided the FDA, physicians, and the general public. Such are very serious accusations, but unfortunately it appears that in some cases they may be accurate. The lack of adequate research into the effects of the meshes on patients and of full testing of the product to ensure it could be safely installed and removed combines with the lack of proper warning labels to build a strong case for a defective product lawsuit.
Legal Options for Victims
Those harmed by a transvaginal mesh device should seek legal counsel and representation to vastly increase their chances in court of receiving full compensation in accordance with law. Many similar cases have already been won, and it likely only remains to examine the details of your case and to prove in court that the mesh was responsible for bodily harm inflicted upon you or a loved one.