vaginal implants

More than 300,000 U.S. women face surgery in the U.S. each year for pelvic-organ prolapse such as a fallen bladder or rectum or dropping uterus. Repairs can be done using the patien’t’s own tissues or augmented by biologic (animal or human tissue) or synthetic mesh (usually polypropylene). Study results conflict but it has been widely agreed upon that when mesh repairs are performed that the anatomical results are superior though the subjective results are quite close. In other words the same number of women satisfied by mesh and non-mesh repairs are close. Women often do not feel a failed surgery that their doctor sees as failed objectively. Experienced vaginal surgeons may disagree with these conclusions because the studies often do not take into consideration the skill levels of individual surgeons. A study in the May 2011 New England Journal of Medicine has concluded that the newer technique of supporting the internal organs with a mesh trampoline produces better short-term success, but complication rates are higher. The study came when growing popularity for the mesh surgery was compared to the older method of stitching sagging organs back into place with an anterior repair or colporrhaphy. None of the marketed kits have been extensively tested against each other. Surgeons have sought a better repair method because traditional surgery has a 40% risk of failure and recurrence. That is too many failed surgeries in the eyes of the full time pelvic surgeon. In the randomized multi-center trial, 189 women had colporrhaphy and 200 had their vaginal walls supported with a standard thickness mesh kit. Just under 16% were having the surgery as a re-do of a failed primary surgery.

At the one-year mark, 61% who got mesh repair were free of any prolapse compared to 35% among the women in the colporrhaphy group. The success rates were relatively low because the researchers were very strict about what constituted a success. Not only did patients’ organs need to be repositioned, but “the patient must have no sense of bulging and protrusion. When you say that, the success rates drop. Mesh repairs had higher blood loss, took longer, and had more bladder injury. At the one-year mark, mesh patients were more likely to report new stress urinary incontinence or leaky bladder (12.3% for mesh treatment vs. 6.2% for colporrhaphy). The incontinence “could be due to damage to the urethra and supporting structures, but it could also be that the procedure is too effective. It overcorrects the bladder base and it lifts it up a little too much,” according to the researcher. These were easy to correct when found.

Another study of 1172 patients were evaluated at a short-term follow-up (mean, 3.6 months) and a 1-year follow-up. Twenty (1.7%) reported intraoperative complications and 44 (3.8%) reported postoperative complications. There were no bowel injuries in this study. The subjective success rate of the surgery was 92.8% and the anatomic success rate was 98.2%. These success rates were significantly higher than standard repair without mesh. Researchers noted that “a lot of dissatisfaction came from persistent overactive bladder symptoms not eliminated by surgical repair. Another researcher noted that the significant difference in this study was that the surgeons were all very experienced. Typical mesh erosion rates found in many studies ranged from 10-20+% when using standard thickness vaginal mesh. The 2.9% incidence of vaginal mesh exposures “is very different from earlier studies” suggesting that transvaginal mesh surgery is a good option with the right patient selection and the right surgeon. The researcher stated that “members of AUGS (American Urogynecological Society) need to correct the public perception that transvaginal mesh is toxic and dangerous for our patients.”

More recent research has pointed to very high success rates and very low complications rates with the use of “Ultra-lightweight” mesh in appropriate patients undergoing pelvic reconstruction. With over 1,000 mesh implants in over 700 patients and up to 8 years of follow up, Dr. Red Alinsod has reported a long term success rate of over 98% with bladder repairs and over 99% with rectocele repairs. All repairs were done vaginally without the need for robotics and its numerous holes placed on the abdomen. Uterine prolapse and vaginal prolapse repairs were also 95% successful. The very light and airy mesh were soft and flexible and completely not palpable or felt once implanted. It had an exposure rate of only 1.4% with bladder rapairs and 0.5% with rectocele repairs. Most were trimmed uneventfully in the office setting. There was a 3-5% risk of resultant pelvic pain with intercourse versus the reported 16% when standard plication was used. There was indeed more bleeding with pelvic mesh repairs with a transfusion rate of about 5%. Complications were highly dependent on the skill and experience of the surgeon. The more cases the surgeon performed the lower his complication rate became. Important points stressed were that failed surgeries from standard repair results in the need of a repeat or reparative surgery which in itself is more dangerous than simple office trimming or band release when mesh is exposed. Mesh repair is able to handle the most severe cases and failed prior cases that standard repair is known to fail often with. There is a developing opinion among the most experienced surgeons that when there are minimal to no symptoms when prolapse is present that no surgery is needed. Pessaries (vaginal supporting “plugs”) can be used in these mild to even severe cases. When there are more symptoms that interfere with normal living then surgery can be considered. These are usually the moderate or severe prolapses when a bulge is seen or felt coming out of the vagina. When the vagina goes “inside out” then surgery is certainly recommended if pessary use is declined. These pelvic prolapse symptoms are quite distressing to women both physically and emotionally.

For patients with pelvic prolapse contemplating surgery the most important research to be done is to find the most experienced vaginal surgeon whether repair is to be done with the patient’s native tissue or with biologic or synthetic mesh. If contemplating mesh augmented surgery the goal is then to find the thinnest and lightest and most flexible mesh available to be placed by a skilled surgeon who has done hundreds of cases. Avoid the surgeon who insists on only doing non-mesh repairs or only doing mesh repairs. There is a role for both. Individualized care is an important concept and a full discussion of the choices is essential.