If you have had a transvaginal mesh implant (TVM), you should be aware of the potential problems that may exist and that have occurred for many of the women who have had this procedure performed.
TVM has been utilized as a treatment for pelvic organ prolapse (POP), and stress urinary incontinence (SUI), both of which conditions can often affect older women who have experienced vaginal childbirth, a hysterectomy, and/or menopause.
POP is a condition that occurs when certain muscles holding up certain pelvic organs, such as the uterus, the bladder, the rectum, the top of the vagina (vaginal apex) , and the bowel, become weak or stretched. When this happens, these organs can “prolapse,” or drop or sag, into the vagina, even to the point of protruding through the vaginal opening. Women who suffer from POP often feel heaviness or pressure in the vaginal area, or even sense that something is falling out of their vagina. It can also cause difficulty or changes in urination, constipation, as well as general discomfort or even pain during intercourse.
SUI is the most common form of incontinence suffered by women. SUI is caused by weakened pelvic muscles, and is more common in women who have had multiple pregnancies and undergone vaginal deliveries. POP can also cause SUI. Normally, a sphincter muscle around the urethra prevents urine from leaking from the bladder. When the pelvic sphincter muscles are weakened, women can experience SUI: urine can escape when pressure, or stress, is placed upon the abdomen, such as when a woman sneezes, coughs, laughs, lifts a heavy object, or exercises.
Although many women suffer mildly from POP or from SUI, some experience these conditions to the point that they seek medical treatment. Among the treatments that have been offered over the last decade is TVM. TVM is a medical device, designed like a sling, that is implanted into the pelvis to support weak or damaged tissue. The mesh is manufactured from synthetic or biological material, and surgically implanted into the base of the pelvis to assist weakened muscles and hold up prolapsed organs. The implant is permanent, and the intent is to reinforce a weakened vaginal wall, for POP, or urethra, for SUI.What Complications Have Been Associated With Transvaginal Mesh?
Mesh implants have been used in other surgical procedures, most notably in hernia operations. The idea is that a synthetic mesh implant can essentially reinforce a weakened muscle and prevent further damage or degeneration. Use of mesh for hernia treatment had been approved by the FDA prior to the development of TVM.
A mesh sling for treating POP, designed by Boston Scientific, had also been approved by the FDA, although Boston Scientific later recalled the device on its own without FDA intervention. As a result of these prior approvals, when various TVM devices were later proposed as a solution for treating POP and SUI, the FDA proceeded to approve them under a review process that was less rigorous than it would otherwise have been for a new medical device with a new application. As a result, when TVM came on the market with FDA approval, it was originally regarded as breakthrough medical treatment for POP and SUI. Unfortunately, it has since proved to be highly problematic, and even dangerous.
TVM implants have now been shown to result in a variety of painful, damaging, and frequently irreversible complications. Even worse, instead of remedying the conditions treated, they have often exacerbated them or led to more serious and debilitating problems.
The most common complication associated with TVM implants also ends up being the most damaging: erosion of the mesh. The edges of the mesh can cut through the vaginal lining and perforate the bladder , the bowel, blood vessels, and other organs. In addition, the mesh can disintegrate, and embed itself in the surrounding tissue. Symptoms and problems associated with TVM include:
Unfortunately, many of these complications may require additional treatment, including surgery or multiple surgeries, and some of the problems caused by TVM implants may not be reversible.
In 2008, after receiving numerous reports of adverse impacts from TVM, the FDA issued a public warning. Later, in July 2011, the FDA issued a Safety Communication directed at the healthcare professionals who perform TVM surgery as well as those who treat patients who have had TVM implants; it also cautions patients considering TVM implants as a treatment for POP and SUI. The Safety Communication states that TVM is not superior to other traditional methods of treating POP or SUI, and that TVM may cause adverse reactions that these other methods do not have. And while the FDA states that there are “serious complications” associated with TVM, it has not banned the use of TVM for treating POP or SUI.If You or Someone You Love is Experiencing or Has Experienced Complications from TVM Implants, Grimes Teich Anderson can Help
If you have undergone a TVM implant and experienced any or some of the problems outlined on this page, you should be aware that there may be a way for you to obtain compensation for your injuries. Several manufacturers of TVM implants have already been found legally liable for the injuries caused by their products, and have been forced to pay damages to TVM patients. Even if you have not yet suffered any adverse impacts from TVM, potential problems may currently exist with your implant, and it is important to know what your risks are and whether you may be entitled to damages for the risks, distress, and anxiety you may be experiencing.
It is important to note that, while specific manufacturers of TVM devices—specifically, C.R. Bard, Boston Scientific, and Johnson & Johnson’s Ethicon—have recalled their products, the complications experienced by TVM patients are not associated with any particular manufacturer or brand of mesh or mesh devices; the problem seems to be with the procedure and the product itself, rather than a particular manufacturer or material. All TVM device manufacturers, or any physicians who improperly implanted these devices, may still be held liable despite any corrective action they may have taken subsequent to discovering problems.
At Grimes Teich Anderson , we understand how unnerving and embarrassing it can be to discuss a personal medical problem with anyone, particularly a medical problem that affects such a sensitive issue as incontinence or sexual discomfort. We know what you are going through, and we can help you. Remember that you are not alone: it is estimated that, in 2010 alone, nearly 300,000 women suffered from POP, and 70,000 of those women underwent TVM surgery. In addition, nearly 185,000 women have undergone TVM surgery for SUI. If you have a problem with a TVM implant, you do not need to suffer alone or in silence.
The personal injury attorneys at Grimes Teich Anderson are experienced in handling product liability cases. If you are a TVM patient and you live in North Carolina or South Carolina, we are happy to meet with you to discuss your situation and to evaluate your options.* We have offices conveniently located in Asheville, Rutherfordton, Waynesville, and Spruce Pine, North Carolina, as well as in Greenville and Gaffney in South Carolina. If you have been harmed through the negligence of others, contact Grimes Teich Anderson toll-free at 800.533.6845, or complete our online confidential case evaluation form for a free, no-obligation consultation with an experienced and knowledgeable attorney.
*Grimes Teich Anderson LLP works on these cases with Henson & Fuerst PA, Raleigh NC but these claims will be handled primarily by associated co-counsel with offices in other state(s).