A glass box engraved with “Another girl saved by the sling slayer” sits outside the surgeon’s office. A patient was so grateful after Dr. Dionysios Veronikis removed her painful pelvic mesh, she gave the box to him along with purple wooden hearts for others to sign and drop in after their surgeries.
Veronikis has had to buy a lot more hearts.
Women from all over the world are traveling to St. Louis to see Dr. V, as many call him, after word spread of his success at removing the implants. Pelvic mesh implants proliferated over the past decade to treat incontinence or the organs in the pelvis falling out of place (prolapse), usually because of muscles weakened by the stress of childbirth.
Serious complications prompted the FDA in 2011 to issue warnings on implants for prolapse, which has led to nearly 100,000 lawsuits and manufacturers taking products off the market. “But hundreds of thousands of women from across the globe have these products,” Veronikis said.
And they want them out.
Removing the entire implant is a risky and difficult procedure. But after years of pain, lost jobs, lost homes, lost husbands and even multiple failed surgeries — women are determined to find surgeons who can do it.
About 18 months ago, they started to find Veronikis, the director of female pelvic medicine and reconstructive surgery at Mercy Hospital St. Louis in Creve Coeur. Their success stories with Dr. V spread fast.
NO OTHER SURGEON COULD HELP
Two women from Australia recently made trips from across the globe to see Veronikis. So desperate to remove their implants, they were each willing to pay more than $30,000 for the medical expenses and traveling. The pair found each other through social media groups for mesh sufferers, which pointed them to the surgeon.
Caz Chisholm, 45, from Perth in Western Australia, used a combination of loans, credit cards and her savings. “I just decided after all the comments by women about Dr. V, I knew I had to see him,” Chisholm said. “No other surgeon would be able to help me.”
For nearly 12 years after a difficult childbirth, Chisholm’s incontinence kept her from being able to play with her active boy. When he got into soccer, something she enjoyed too, the single mom got sick of missing out.
In January, she had gotten a mesh implant using a technique involving small incisions in her vaginal wall and groin. Her incontinence was cured, but it hurt badly to bend over, sit down, get up and lie down. “I had to get the mesh out,” she said.
Sitting in the lobby of her St. Louis hotel just days after her surgery here, Chisholm was pain-free. At the angle the mesh was implanted, she was told, it eventually would have sliced though her vaginal wall.
Experienced surgeons have long performed bladder slings. The surgery involved opening the abdomen and creating a sling out of other parts of the patient’s body or sometimes a surgical material. Each surgeon had a personal technique, which “made the operation fit the patient, not the patient the operation,” Veronikis said.
The first mesh sling was created in the late 1990s, sold as a strip of mesh inserted through small incisions in the vagina and abdomen. It standardized the surgery and made it less invasive and long term. “It was a good thing,” Veronikis said, becoming the gold-standard treatment for incontinence if done by experienced urogynecologists.
Other companies quickly came to the market with their own versions of slings, a process made easier by the FDA’s classification of transvaginal mesh as a moderate-risk product. Manufacturers did not have to prove safety, only that their product was substantially similar to another in use. To get around patents, each new implant had slightly different variations or surgical tools.
“As things changed from the initial concept, complications changed,” Veronikis said. “Doctors started seeing more problems in their practice.”
Companies also started making mesh kits to treat pelvic organ prolapse. These pieces of mesh were larger, with multiple arms. “That really touched problems off,” he said.
At one time, dozens of products, each with their own set of instructions, were in use. Surgeons — told the procedures were safe and easy — could be trained in a weekend.
In 2010, about 100,000 women in the United States had surgeries using mesh to repair prolapse, and more than double that had surgeries for incontinence, according to the FDA.
“The mass marketing of these products as a better surgical procedure for the treatment of prolapse was just done incorrectly,” Veronikis said. “It needed trials and research.”
From 2008 to 2010, the FDA received 1,371 reports of complications with the more common mesh surgery for incontinence. But there were more than 1,500 reports, including seven deaths, associated with mesh used for prolapse repair — five times as many as the agency had received two years earlier.
The most frequent problems included mesh eroding through the vagina, pain, infection, bleeding, pain during sex, perforated organs during surgery and urinary problems. The implants were also found to shrink and contract. Many women needed additional surgeries or hospitalization.
The findings prompted the FDA in 2011 to issue safety concerns about mesh used to treat prolapse, warning that serious complications with surgical mesh for the repair of prolapse are “not rare.” The federal agency reviewed studies and found that using mesh appeared no more effective than nonmesh procedures.
“The FDA is asking surgeons to carefully consider all other treatment options and to make sure their patients are fully informed of potential complications from surgical mesh,” Dr. William Maisel, a deputy director at the FDA, said at the time. “Mesh is a permanent implant — complete removal may not be possible and may not result in complete resolution of complications.”
In April, the FDA issued proposals to reclassify surgical mesh for prolapse repair as a high-risk device. If finalized, manufacturers must submit studies demonstrating safety and effectiveness before it is sold.
“A society is sometimes judged by the way it treats its women and children,” Veronikis said, “and I think this was a dark chapter. These women’s lives are altered permanently.”
‘I’M ONLY 51’
Chisholm and Kirsty Datar, of Brisbane, scheduled their surgeries at Mercy at the same time so they could support each other.
Datar had a mesh implant to treat her incontinence in 2005, three years after having her fourth child. At first, the active science teacher was able to resume the things she loved such as hiking, biking, running and traveling.
But about two years later, she began to suffer back pain, pelvic pain, digestion problems and aching in her bones. The pain grew more intense. Specialists diagnosed her with celiac disease, diverticulitis, osteoarthritis and other problems. (Datar believes the diseases were autoimmune responses to the breakdown of the mesh in her body.)
This spring, Datar first heard the medical words “transvaginal mesh” on a television show. Searching the term on the Internet, she was shocked to find stories about lawsuits and complications that matched her own.
Datar demanded tests, which revealed her mesh had contracted and was “not in places it should be.” She searched for surgeons to remove it but said she was told they could only get 2 centimeters that had eroded through her vaginal wall. One surgeon failed to remove it all.
She turned to the “mesh ladies” in her virtual support group, and two names surfaced: UCLA Health surgeon Dr. Shlomo Raz and Veronikis, she said.
After dozens of email exchanges with Veronikis, she made the trip. “I’m only 51. I have an 11-year-old son, and this is my one chance of getting the mesh out and staying active in my life and being active in my kid’s life,” Datar said. “My other choice was to be in bed all the time, in pain.”
Veronikis successfully removed all 25 centimeters.
YEARS OF EXPERIENCE
Veronikis has focused his 20-year career on treating women with incontinence and pelvic organ prolapse, starting with a three-year fellowship in vaginal surgery and urogynecology at Massachusetts General Hospital. He is certified in female pelvic medicine and reconstructive surgery, a new subspecialty in obstetrics with exams offered for the first time last year.
Veronikis also has a long history of performing reconstructive surgery for women with an incomplete or absent vagina, which he said helped prepare him for the complicated procedure of mesh removal. Risks include puncturing nearby organs or uncontrollable bleeding.
“These vaginal meshes were designed to be easy to put in and are theoretically very safe and effective. What we found is that they’re not as safe or effective as they thought, and when it came time to start taking them out it became very difficult,” said Dr. Neeraj Kohli, a surgeon. Kohli runs a private practice in Boston after serving as division chief of urogynecology at Harvard Medical School’s Brigham and Women’s Hospital.
“There are only a handful of surgeons around the country who feel comfortable and confident to remove them and (Dionysios) is probably at the top of that list,” said Kohli, who said he had been friends with Veronikis for 15 years.
Many who turn to Veronikis have struggled for years to find help, Kohli said, and, in many instances, these patients have lost faith in medicine and doctors.
Veronikis collected all the different mesh products so he could understand how each is constructed. He also created his own surgical tools and procedures to get better views of the surrounding organs.
He believed early on that removing the mesh implant rather than just trimming troublesome pieces has better outcomes for patients.
“There’s no instructions on what to do when the mesh has eroded into the vagina. I took the approach that it needs to be removed,” he said. “When it becomes infected, it needs to be removed. When you have pain, it needs to be removed.”
Unless a woman has had too many surgeries, he said, removing the implant also can pave the way for a surgery to treat the incontinence or prolapse by an experienced surgeon.
As women shared their results on social media, others from across the U.S. and the world showed up in his office. Veronikis used to remove about 30 mesh implants a year and now he removes more than 30 a month, he said.
Women leave in tears, so grateful to be rid of implants that left them unable to make love to their husbands, bedridden or dependent on their parents.
The patients don’t just sign and date their purple hearts, they painstakingly paint and decorate them. They send Veronikis superhero surgeon caps, pillow cases and Christmas ornaments.
“Many patients,” he said, “say, ‘You saved my life.”