LAS VEGAS — Approximately 1% of patients who received at least one American Medical Systems product for pelvic prolapse repair had a serious, device-related adverse event that required reoperation or extended hospitalization, data from a registry of 670 patients showed.
The extrusion rate for AMS prolapse devices was 3.5%, and the erosion rate was 0.3%, Dr. Samuel Zylstra reported at the annual meeting of the AAGL.
“In general, the repairs are very successful,” said Dr. Zylstra, director of urogynecology services at Milford (Mass.) Regional Medical Center. “But we need some kind of standard of care control to let people know what's going on with these cases. We're probably missing cases that we haven't captured.”
In an ongoing registry launched in October of 2006 and supported by American Medical Systems Inc., manufacturer of the Perigee and Apogee mesh implant systems, Dr. Zylstra and his associates at 21 sites in the United States and New Zealand followed 670 patients who received at least one AMS product for prolapse repair, with no other restrictions on product type.
To be eligible for inclusion, the patients had to be at least 18 years of age and indicated for an AMS product. The length of follow-up was 2 years.
Both the Pelvic Organ Prolapse Quantification System and the Balden-Walker system were used to quantify types of prolapse. Treatment success was defined as improving at least one prolapse stage from preoperative baseline.
Most of the 670 patients were white (95%) and their mean age was 60 years. Their mean parity was three and their mean body mass index was 28 kg/m2.
Dr. Zylstra reported that 85% of patients had cystoceles repaired, 66% had rectoceles repaired, 56% had vault prolapse repaired, and 49% had enteroceles repaired. “Interestingly, 30% of all patients had all four of these compartments repaired during the same surgery,” he said.
In addition, 78% had incontinence repairs and 29% had hysterectomies performed concomitantly.
The median blood loss was 160 cc, and the median procedure time was 78 minutes.
The rate of intraoperative complications was 2.5%. “The majority of these were either hematomas or bladder perforations,” said Dr. Zylstra, also of the University of Massachusetts, Worcester. “There was one fistula, and another minor complication was related to the mesh insertion kit.”
Most of the patients (87%) were free of prolapse device-related events. On the converse side, 12% of the patients experienced at least one prolapse device-related event, and 1% of patients experienced a serious device-related event, he reported.
The variation in the rate of reported events across sites was high with an interquartile range of 0–13.5. The median rate of prolapse device-related adverse events was 4% across sites.
Of the patients experiencing at least one prolapse device-related event, 3.5% had an extrusion, meaning mesh that eroded through the vaginal mucosa, and 0.3% had an erosion involving the urethra/bladder. Other prolapse device-related events included continence issues, intraoperative events, healing, pain, granuloma formation, and dehiscence.
Six of the patients (0.9%) had a serious adverse event, defined as one that requires patients to be returned to the operating room for an additional procedure or an increase in postoperative hospital stay. Three of these cases were anterior cystocele repairs.
“One developed an infection in the vault which required surgical intervention and antibiotic use,” Dr. Zylstra said. “The second developed pain at the point of insertion [attachment] of one of the tapes to the body of the polypropylene mesh. That was removed and the patient did fine thereafter. A third patient had some mesh that separated and required surgical repair.”
The other three serious adverse events were in the posterior compartment with a rectocele or enterocele. “One of these was a recurrent apical enterocele/rectocele that caused constipation and difficulty with bowel movements,” he said. “That was repaired. A second had an intrusion into the introitus. The third had an extrusion through the posterior vaginal mucosa.”
Follow-up prolapse measurements showed clinically significant improvement from baseline by at least one prolapse stage in all types of repair except for that of the posterior/apical compartment.
“One of the reasons for that might be the difficulty in measuring enteroceles,” Dr. Zylstra hypothesized. “It may also be that with the posterior repairs, different clinical sites would use a different anchor for the Apogee.” The new “Elevate” procedures attach to the sacrospinous ligaments about two centimeters from the spinous process and demonstrate consistent posterior/apical support.
In light of these findings and the Oct. 21, 2008, Food and Drug Administration notice about adverse events associated with surgical mesh, Dr. Zylstra emphasized the need for physicians to follow patients who have undergone pelvic repair with mesh products “very carefully, looking for signs of erosions and extrusions, and following them for pain and infection issues.
“The other thing that is important is a careful informed consent, telling our patients that there is about a 1% chance that they may have to return to the operating room to be repaired with additional surgery,” he said.
Dr. Zylstra disclosed he has received research and grant support as well as consulting fees and honoraria from American Medical Systems for this registry and has provided Medtronic with similar support on other projects.
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