Doctors say women still have safe options in pelvic surgery
“How did I not know about this? I can’t believe I don’t know this stuff. The more I read, the more ticked off I got.”
Sherrie Palm, now 65, was blindsided in her mid-50s by pelvic organ prolapse, something she said she’d never heard of. She said she discovered a walnut-sized lump protruding from her vagina.
Half of women over 50 have prolapse and it’s estimated that about 10% will need surgery. The most common risk factors are vaginal childbirth and menopause, a time when estrogen, which helps to keep pelvic muscles strong, is in lower supply.
Prolapse means pelvic organs — the bladder, uterus and the small or large bowel — drop downward and bulge into the vagina. It can interfere with comfort and organ functions.
One type of prolapse repair surgery was recently affected by an April 16 order from the U.S. Food and Drug Administration that banned a synthetic mesh product used in the surgery. Addressing problems associated with mesh, researchers at the Magee-Womens Research Institute are testing materials that may work better within a woman’s body.
Surgery implanting synthetic mesh to reinforce the vaginal wall and support prolapsed organs has become popular over the past 20 years. Placing the mesh through the vagina, transvaginally, was offered as a less invasive approach than through the abdomen.
However, a boom in transvaginal mesh products was met with an increasing number of women reporting serious complications after surgery. They include chronic pain, infection, bleeding, pain during intercourse, urinary problems and pieces of mesh poking through the vagina.
After stepping up mesh product-review requirements, the FDA ended the sale of mesh used in transvaginal repair of the most common type of prolapse, called cystocele.
Ms. Palm, of Mukwonago, Wis., had transvaginal mesh surgery in 2008 and had a good recovery. She said she was so angry that she knew so little about the condition, she plunged herself into the topic — learning the facts, building a nonprofit
support group, writing a book (“Pelvic Organ Prolapse: The Silent Epidemic”), and speaking and advocating for women’s health.
Now she’s dedicated to getting the word out that women still have options in surgery to repair pelvic organ prolapse, despite the FDA ban. The news caused an uproar among participants in Ms. Palm’s online Association for Pelvic Organ Prolapse Support, a place for women to share their stories and find solutions.
Although clinical studies on mesh safety and effectiveness were still being evaluated, the FDA ordered the two mesh manufacturers to stop selling and distributing their products immediately. Considered high-risk products since 2016, they didn’t demonstrate benefits that would outweigh the risks, according to the FDA.
Women with the transvaginal mesh are advised to continue with their regular medical care and no further action is needed if they’re not having problems. But that didn’t prevent an outcry from women.
“We’ve received a lot of phone calls from patients since the order in April,” said Dr. Lindsay Turner, Allegheny Health Network urogynecologist. “These are women who have had surgical mesh in place or have plans for surgery.”
Patients incorrectly believe that the FDA ban applies to all mesh, Dr. Turner said. “Many of the products we are still using are safe and approved by the FDA.” She said most patients in her practice who were originally transvaginal candidates have chosen the option of laparoscopic surgery, with an incision in the abdomen. Treating prolapse In addition to cystocele, which involves the bladder pushing into the vagina’s front wall, other types of prolapse include rectocele, involving the vagina’s back wall and the rectum; enterocele, involving the upper vaginal wall and small bowel; and uterine prolapse, when the uterus drops down into the vagina.
Nonsurgical treatment includes physical therapy to strengthen pelvic floor muscles and pessaries, devices inserted into the vagina for support and to relieve pressure on the bladder and bowel.
Traditional reconstructive surgery uses a woman’s own tissue to correct the prolapse. It can be done laparoscopically through the abdomen or through the vagina. However, if the tissue continues to be weak and stretched, repeat surgeries may be needed.
A screen-like material, most mesh used in women’s pelvic reconstructive surgery is made of non-absorbable synthetic polypropylene. It can break down, and in half of those cases, the mesh may have to be removed.
Laparascopic surgery to insert mesh to support the upper vagina is called sacrocolpopexy. The mesh used is not the type banned by the FDA. It has a high success rate and few complications compared to the mesh in transvaginal repair.
Sacrocolpopexy, however, calls for specially trained surgeons, and not all patients can tolerate the surgery.
“The complication rates are much lower, and we’re satisfied with the success with those,” Dr. Turner said. “We have an individualized conversation with each patient.” Some are more at risk for complications and some patients aren’t a good match for mesh surgery.
For those, she said, natural tissue repair may be best. For longer-term success, she said, biological grafts (animal-based) can be used to restore support in the pelvic area.
Women who lift heavy objects regularly or who are very active are steered toward mesh repair.
“The ideal property of mesh is one that is durable and very lightweight,” Dr. Turner said. Also, she said it should have properties that allow good healing after surgery.
A new type of mesh Because transvaginal mesh fills a need for many women, it should be improved instead of eliminated, according to Dr. Pamela Moalli, professor of obstetrics, gynecology and reproductive sciences at the University of Pittsburgh and pelvic reconstructive surgeon at UPMC MageeWomens Hospital. She recently received a five-year, $2.5 million grant from the National Institutes of Health to make better mesh.
The work has started in Dr. Moalli’s research group at Magee-Womens Research Institute, in a partnership with Steven Abramowitch, Ph.D., associate professor of bioengineering at Pitt. They plan to evaluate strong but somewhat flexible polymer materials, to replace the stiff polymer now used in mesh.
Mesh was introduced to offer women longer-lasting support, since natural tissue repairs tend to fail within two to seven years, Dr. Moalli said.
“Complications related to a mesh are fairly unusual,” she said, estimating that sacrocolpopexy has a complication rate of about 6-8%. Midurethral slings, using mesh to support the urethra to treat stress incontinence, has a 6% rate.
“Most do very well,” Dr. Moalli said. “The goal in our lab is to completely eliminate any complications and to understand why they occur.”
Magee surgeons do sacrocolpopexy procedures often, she said, rebuilding ligaments in the vagina using biological materials and mesh. “We see very few of the complications they see in other parts of the nation. It requires a lot of surgical skill.”
The transvaginal procedure, introduced in 2005, used materials not designed specifically for it, she said, and the products were marketed to nonspecialists.
“Seventy percent were put in by people who didn’t have the appropriate training,” she said. “The patient population in which they were implanted may have had conditions that made them more susceptible [to complications].”
The patient’s tissues respond to mesh as a foreign body, by surrounding it with a fibrous capsule. However, with a lot of mesh products, Dr. Moalli said, there can be a heightened response — too much inflexible tissue and mesh can cause pain and discomfort.
“One problem with current materials is they might be too stiff; the vagina is very, very soft,” she said. “The other thing is the vagina is very elastic. It can expand and contract when you sneeze. We were interested in finding softer polymers and pores that when forced will change so they don’t collapse. So when you cough and sneeze, they change and then go back to their original shape.”
After studying meshes available, Dr. Moalli said she’s been doing minimally invasive sacrocolpopexy surgeries with square-pored mesh and she hasn’t had a patient with complications. In the future, she said, a material might be custom-tailored to suit an individual.
More needs to be known about women’s responses to mesh, she said, but for now, “Women can be reassured that most women are going to do well by far with materials we’re using right now.”