Transvaginal mesh is intended to become implanted in the tissues (like the vaginal wall), strengthening weakened areas, eliminating organ prolapse, and permanently resolving pain and incontinence. Although transvaginal mesh surgery is simpler, less invasive, and more effective than more traditional treatments for pelvic organ prolapse (POP) and stress urinary incontinence (SUI), it also carries a higher complication rate.
Unfortunately, what sometimes happens is the mesh shrinks once implanted in the vaginal tissue, causing vaginal shortening, tightening, and intense pain. Another more serious possibility is that part of the mesh material does not get absorbed into the tissue as intended, and instead remains free inside the pelvic area. The sharp edges of the mesh can perforate surrounding organs or cut into the vaginal wall.
Clinical trials investigating the risks associated with transvaginal mesh indicate there is a higher rate of organ perforation using this method. In a 2011, a Swedish study was conducted comparing the outcomes of 389 women, all suffering prolapse in the anterior (front) vaginal wall; 200 underwent transvaginal mesh repairs, and 189 underwent colporrhaphy (a procedure that uses the patient’s own connective tissue to add support to the weakened muscles). After one year, approximately 60 percent of the women treated with transvaginal mesh achieved positive outcomes (no recurrence of the prolapse), while only about 34 percent of the colporrhaphy patients achieved the goal. However, complication rates were significantly higher for the transvaginal mesh group. They experienced a:
- 3.5 percent rate of bladder perforation
- 12.3 percent rate of new stress urinary incontinence after surgery
- 3.2 percent rate of follow-up surgery to repair mesh erosion
While this study only tracked a few adverse outcomes, when mesh implantation fails, it can cause multiple negative symptoms, including:
- Mesh erosion into the vagina, bladder, uterus, and bowels (some patients have even experienced the mesh exiting the body through the vagina)
- Organ perforation
- Chronic pelvic pain
- Chronic bleeding (due to perforation of blood vessels)
- Abscesses (pus-filled sores)
- Pelvic infection
- Recto-vaginal fistula (a tunnel/opening between the rectum and the vagina allowing feces to escape through the vagina)
- Nerve damage and neuromuscular problems
- Difficulty urinating
- Dysfunction in emptying the bowels
- Painful intercourse
- Vaginal scarring and disfigurement
- Recurrence of original POP or SUI symptoms, including another painful prolapse episode
- Psychological trauma
These complications necessitate additional surgeries—referred to as revision surgery—to remove the device and repair damage. However, because synthetic surgical mesh was designed to integrate itself into the tissue and stay in the body indefinitely, removal of the mesh is extremely difficult. Blood vessels and tissues grow around the mesh, requiring doctors to remove it in pieces, one surgery at a time. In some cases it may not ever be possible to remove all the mesh. Even if the mesh can be removed, some women are still be left with some of the complications listed above.
On July 13, 2011, the FDA reported it had received 4,000 reports of complications related to transvaginal mesh used to repair POP and SUI during the preceding six-year period, with more than half—2,874—occurring from 2008 to 2010. The statement also reported seven deaths during the 2008–2010 period associated with procedures using transvaginal mesh. Three of the deaths were related to the mesh placement procedure (two bowel perforations, one hemorrhage) and the remaining four resulted from complications caused by the implant.
Previously, the FDA had said that complications from transvaginal mesh surgeries were rare, but 2011’s report warned patients and doctors that they are common. They also concluded, after reviewing the existing literature, that transvaginal mesh repair doesn’t appear to have any benefits over the traditional surgical methods and advised patients to consider alternative treatments. As a part of its alert, the FDA noted that there has been no determination of the specific factors that cause patients to be at increased risk for complications. The list of potential contributing factors may include the health of the patient, the mesh used, the surgical technique, simultaneous procedures (additional surgical procedures that are performed during the same operation, such as a hysterectomy), and estrogen status.
What this means is that, without any indicators of risk, some women might have surgery to repair POP or SUI and then experience serious complications. If you have already had transvaginal mesh implantation as part of surgery to address POP or SUI, be vigilant about any body changes (swelling, bleeding) or unusual symptoms (fever, tenderness, pain, problems with urination and defecation) you may experience. If you notice any of these symptoms, go back to your doctor immediately.
If you have had transvaginal mesh implantation and have developed complications, you may be entitled to financial compensation for your medical bills and pain and suffering. Our experienced team of attorneys can evaluate your case and advise you on whether you have basis to file a suit. We will be your advocate against the company that manufactured the product that has caused you harm or injury. To find out if you have a claim, please call Avram Blair & Associates P.C. at 919-729-5152?? or contact us online.