What is Pelvic Organ Prolapse?
When a pelvic organ—such as the bladder, uterus or vagina—drops, or prolapses, from its normal spot, it can push against the vaginal walls. Typically this occurs when the ligaments holding the pelvic organs in place become fragile or over-strained. The most common causes of pelvic organ prolapse (POP) are childbirth or surgery such as a hysterectomy. Pelvic organ prolapse can be worsened by obesity, a chronic cough, or pelvic organ tumors; typically older women are more likely to have POP and it also tends to run in families. Women who suffer from POP can suffer severe pain as well as a host of other issues. The corrective surgery commonly used since the 1970’s to repair pelvic organ prolapse involves the use of surgical mesh implants.
How is the Mesh Implant Used in POP?
The surgical mesh implant material is used to reinforce the ligaments, providing necessary support for other pelvic organs. This mesh is typically manufactured from polypropylene, polymers, titanium, Gore-Tex and/or Teflon, or a combination of these materials. The mesh materials are formed into slings to correct stress incontinence or surgical mesh slings which are used in the treatment of pelvic organ prolapse. In the treatment of pelvic organ prolapse or stress incontinence, a surgeon makes a minor incision into the wall of the vagina, implanting the mesh device into specific pelvic spaces. The mesh is attached by stitches or a particular tissue fixation device to various points in the muscles of the pelvic floor and surrounding ligaments. In theory, as time passes, cells grow into the small holes in the mesh and create a “hammock” type of support system, strengthening the surrounding tissue and curing the problem.
FDA Approval and Subsequent Concerns
While the mesh was used widely for POP and SUI surgeries, it was a sort of “off-label” use until 1996 when the FDA approved the mesh implant specifically for SUI surgeries, then in 2002, approved a similar mesh product designed for pelvic organ prolapse use. In 2010 alone, over 75,000 women received transvaginal mesh implants during surgery for vaginal prolapse or to shore up weak pelvic muscles which are failing to support internal organs as they should. Decades ago when the mesh implant was being used primarily for hernia repair, there were concerns about the tendency of the mesh to sometimes bunch up after the incision had been sutured, leading to infections, however there were no serious or fatal complications noted.
More Complications During Transvaginal Surgery Applications
Once the mesh was being used in transvaginal applications, more complications were reported, and on October 20, 2008, the FDA issued a Public Health Notification regarding the potential dangers associated with surgical mesh placement through the vagina in the treatment of SUI and POP. The idea behind this particular FDA warning was to let physicians and the public known that complications when surgical mesh was used in a transvaginal repair were not particularly rare. In fact, the number of adverse events between 2005 and 2007 when the mesh implant was used was well over 1,000. From January of 2008 through December of 2010, nearly 3,000 more reports of serious complications were reported when the mesh implant was used to repair pelvic organ prolapse or stress incontinence. Following the warnings in 2008, many more reports were noted, most commonly that the surgical mesh had eroded through the vaginal walls, causing severe pain, infections, bleeding, perforation of surrounding organs, urinary difficulties and pain during sexual intercourse.
Erosion of the Mesh Implant
Vaginal mesh erosion can occur when the surgical mesh does not bind as it should to the vaginal tissues. If this occurs, the mesh can work its way through the vaginal wall, protruding outside and causing potential infection or serious pain. When mesh erosion occurs, revision surgeries are generally required to correct the damage done by the implant. The vagina is the most common area the surgical mesh implants are likely to erode as the incision line could fail to heal properly and could even be felt during sexual intercourse.
The woman may feel pulling or tightness, which in turn leads to infection—sometimes serious or fatal—discharge or bleeding. On average, transvaginal mesh which erodes does so within 4-5 months when used in transvaginal applications, yet when implanted through the abdomen, the average time for mesh erosion was 15 months. Most mesh erosion cases require at least two surgeries to repair, and sometimes more, although in some cases a partial mesh removal surgery is performed in which only the portion of the exposed mesh is removed.
Mesh Contraction or Shrinkage Following Mesh Implant
In other cases, the surgical mesh implants can create specific problems of vaginal shortening, tightening and pain. Mesh contraction can cause such severe pelvic pain or pain during intercourse that those who have had the implant lose their ability to enjoy their life because the pain is relentless. Women who have suffered contraction or shrinkage of the mesh can suffer severe emotional damage and physical symptoms as well.
Bleeding or Infection Following Mesh Implant
Hemorrhaging or bleeding, possibly severe or even fatal can occur following a transvaginal mesh implant. The FDA announced that the surgical mesh implant put women at a significantly higher risk for complications such as mesh bleeding than a standard procedure with stitches. Patients who have undergone a transvaginal mesh implant can develop bladder or urinary tract infections, kidney infections or potentially serious blood infections referred to as sepsis. The blood infections are, of course, the most severe as the infected blood can spread quickly throughout the body. Symptoms of an infection include abdominal pain or pressure, blood in the urine, confusion or disorientation, fever and chills, frequent and/or painful urination, irritability, nausea and vomiting. Women experiencing any of these symptoms following a transvaginal mesh implant should receive immediate medical attention.
Recurrence of Prolapse or Incontinence Following Mesh Implant
In many cases when transvaginal mesh is used it can fail to connect properly to the surrounding tissues and a recurrence of the prolapse can occur, or the woman may suffer mild to severe incontinence. In either of these cases further surgery will be necessary to repair the damage, and in some cases the surgeon may decide to perform a more traditional surgical procedure instead of replacing the mesh implant.
Urinary Tract Problems Following Mesh Implant
Urinary tract problems are also frequently seen in those who have had the transvaginal mesh implant, and these can range from mild to severe. Those with problems from the mesh can have trouble urinating or may feel pressure to urinate then be unable. Infection in the urinary tract can lead to fever and chills and requires medical attention. Bladder infection symptoms in women can include burning during urination, urine with a strong odor, bladder spasms, abdominal pain, blood in the urine, or, among the elderly, lethargy and mental confusion can be a sign of a bladder infection.
Who is Most at Risk for Mesh Implant Complications?
Any woman who has received a transvaginal mesh patch during a POP or SUI surgery is potentially at risk however there are some factors which may make specific women more vulnerable to complications. The woman’s overall health at the time of the surgery is always a factor, as is the age of the woman. The type of mesh material which is used in the device can be a factor in risk of complications, as can size and shape of transvaginal mesh device. The surgical technique is always a factor as is whether the woman has undergone prior surgeries such as a hysterectomy. Finally, the estrogen status of the woman at the time of her surgery can be a factor in whether there will be future complications following the transvaginal mesh implant.
No Recall in Sight
Although there are thousands of documented injuries caused by the transvaginal mesh patch, at this time the FDA is resisting the issuance of a recall of the device believing this move “too extreme.” One particular clinical trial found a 15.6 % erosion rate after three months in women who have undergone a transvaginal mesh implant, however the belief is still strong among surgeons that the devices offer definite benefits for many women and that the data needs to be studied further before a recall is made. It is likely that the FDA will continue to approve the transvaginal mesh implants as moderate risk, simply requiring additional safety studies or labeling changes. More clinical trials will definitely take place in order to establish whether the benefits of the mesh implants outweigh the risks, and women considering the surgery should make sure their intended surgeon has had the appropriate training in transvaginal mesh repair.
At Sullo & Sullo, LLP, we believe that getting compensation for the harm done by the surgical mesh manufacturer shouldn’t be one more hardship you must endure alone. Our attorneys will work hard to streamline the entire process after we have evaluated your case in order to determine whether you are entitled to compensation. The side effects related to transvaginal placement of surgical mesh can be extremely serious and can lead to long-term problems. Should mesh erosion occur you could be required to endure subsequent surgeries to correct the problem, and each surgery brings more potential problems. Don’t endure the serious side effects on your own—call our attorneys at Sullo & Sullo, LLP for compassionate, knowledgeable legal advice.
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