WEDNESDAY, May 11 (HealthDay News) -- In women, a vaginal mesh
support is more effective for repairing a common type of pelvic
organ prolapse -- which occurs when pelvic organs fall out of place
-- than simply stitching the connective tissue in the vaginal wall
muscle back together, finds new research.
But the newer procedure comes with a higher rate of serious
complications during the surgery, such as bladder perforation and
pelvic hemorrhage, and adverse events after the surgery, including
new urinary incontinence and pain during sex, according to the
study.
"It's already fairly well-known that mesh procedures have higher complications. The likelihood of hitting something you don't want to hit, like the bladder, are higher when the surgeon can't visualize everything he or she is suturing. The flip side to that is the ability to create a better support," said Dr. Scott Chudnoff, director of gynecology at Montefiore Medical Center in New York City, who was not involved in the study.
"Both traditional and novel surgical treatments for pelvic organ prolapse have advantages and disadvantages," echoed the study's lead author, Dr. Daniel Altman, an associate professor and senior consultant at Danderyd Hospital and the Karolinska Institute in Stockholm. "It is therefore essential that the patient and doctor discuss their surgical options carefully before the type and extent of surgery is decided."
Pelvic organ prolapse occurs when the pelvic organs, such as the
bladder and urethra, drop downward, often because of a weakness in
the vaginal wall associated with childbirth, hysterectomy or
menopause. This can cause the vagina to push forward, causing
discomfort and even incontinence.
The standard procedure for repairing a pelvic organ prolapse is
stitching together the area of connective tissue (fascia) where
there is a weakness, according to Chudnoff. This treatment, he
said, is called anterior colporrhaphy.
The novel surgery -- known as the transvaginal mesh procedure --
involves using a piece of synthetic mesh that has what looks like
wings (called trocar) that are used to anchor the mesh. The trocar
is pushed to a higher plane in the connective tissue, anchoring it
more securely, and then sutured into place.
Discussing the novel operation, Chudnoff pointed out that the
U.S. Food and Drug Administration issued a warning in the fall of
2008 about the high rates of complications with transvaginal mesh
procedures.
Although the FDA allowed the devices to stay on the market, the
agency recommended that physicians obtain specialized training in
placing the mesh, that they watch patients carefully for signs of
infection or erosion of the fascia around the mesh, and that they
fully inform their patients of all potential complications.
But, the more traditional surgery has issues, too. According to
background information in Altman's study, the risk of recurrence
has been reported to be as high as 40 percent with anterior
colporrhaphy.
The study involved 389 women in Sweden, Norway, Finland and
Denmark. Researchers randomly assigned the women, who had a
prolapsed bladder -- which occurs when weakened supportive tissue
between the bladder and vaginal wall stretches so much that the
bladder pushes into the vagina -- to one of the two procedures. Two
hundred underwent mesh surgery, while 189 women had the standard
surgery.
One year after the procedure, 61 percent of the women in the
mesh group had no prolapse or only a slight prolapse, compared to
34.5 percent of those in the standard surgery group.
On the other hand, mesh surgeries required more time, and there
was a greater risk of bladder perforation and pelvic bleeding
during this procedure, according to the study. Bladder perforation
occurred in 3.5 percent of women who had the mesh surgery, compared
to 0.5 percent in the standard surgery group. Pelvic bleeding was
also more common in the mesh group, with one woman losing up to
1,000 milliliters of blood.
Rates of new stress urinary incontinence post-surgery were
higher for women in the mesh group -- 12.3 percent versus 6.3
percent in the standard surgery group, and more women in the mesh
group reported pain during intercourse (7.3 percent versus 2
percent).
In the mesh repair group, six patients (3.2 percent) also had to
undergo another surgery for mesh-related complications, and five
underwent a new surgery to correct new stress incontinence,
compared to one additional surgery for prolapse recurrence in the
standard group.
Results of the study are published in the May 12 issue of the
New England Journal of Medicine.
"Surgical treatment of pelvic organ prolapse should take into consideration a number of factors," including the patient's type and size of prolapse, previous pelvic surgery and gynecological history, and co-existing medical conditions, as well as the patient's lifestyle and daily activities, Altman explained.
"The study shows that use of a synthetic implant, placed using a standardized surgical technique, may improve outcomes of prolapse repair compared to traditional surgery," Altman said.
"The new method was, however, associated with higher rates of complications, which may occur up to one year after the operation. For this reason, the benefits of the implant-based method must be balanced against the higher rates of adverse events associated with this approach," he concluded.
More information
Learn more about pelvic organ prolapse from the
American Congress of Obstetricians and
Gynecologists.