Background: About 13 million American women experience stress urinary incontinence (SUI), a leaking of urine during moments of physical stress that can include coughing or laughter. Suzanne McClain of Maben, Mississippi went to her doctor with the problem in 2004. He assured her he had an easy fix.
“He told me it was the most wonderful thing invented,” McClain says, “and that I’d never have this problem again.” Readers of Suffering in Silence- Part 1 and Suffering in Silence- Part 2 have reported a myriad of complications with nowhere to turn. Here in Part 3, the experts weigh in.
Suffering in Silence
43-year-old Suzanne McCain’s doctor recommended outpatient surgery to support weakened muscles and support the bladder. He would implant a sling, made by Ethicon, made from a synthetic mesh material roughly the size and shape of a ribbon, placed under the urethra and the bladder.
Ethicon says its TVT tension-free vaginal tape procedure has been the preferred treatment for female stress urinary incontinence (SUI) since 1995 and is now considered by many to be the “gold standard” procedure because of its simplicity“ and excellent long-term efficacy.”
In fact Ethicon claims a 84 to 95 percent success rate among the one million procedures using TVT.
“It’s the most studied vaginal sling on the market for the treatment of female stress urinary incontinence,” says Jackie Jankewicz, of the Ethicon division of Johnson & Johnson located in Somerville, New Jersey.
And it’s profitable too. Ethicon’s first quarter of 2009 reports earnings of meshes and bio-surgical helped drive Ethicon to double digit growth.
The FDA issued an unusual Public Health Notification on October 20, 2008: "Serious Complications Associated with Transvaginal Placement of Surgical Mesh in Repair of Pelvic Organ Prolapse and Stress Urinary Incontinence” and said it had received over 1,000 reports from nine surgical mesh manufacturers of complications.
In some cases, the mesh had traveled in the body and perforated the bowel, bladder, and blood vessels, leading to infection, pain, urinary problems, and recurrence of prolapse and/or incontinence.
Doctors were told to tell patients that ‘implantation of surgical mesh is permanent” and additional surgery may be needed. Patients with problems should report them to the FDA’s Adverse Event Reporting System online.
Suzanne McClain knows the mesh is permanent. In July 2008, her new doctor, a urogynecologist, confirmed the mesh had eroded through her vaginal wall. One month later she had surgery to extract about one-third of the mesh medical device. The rest had to be left behind. To remove it was too dangerous.
Interestingly, the FDA does not say whether it accessed its own MAUDE database (Manufacturer and User Facility Device Experience database) of adverse events or problems that is set up for patients, doctors, or institutions to report their personal experience with a medical device.
If it had, the database would have shown an additional nearly 1,000 adverse reports, including several deaths.
The Experts Weigh In
Dr. Larissa Rodriguez believes the numbers are underreported.
She should know. At the University of California, Los Angeles School of Medicine, Department of Urology, Dr. Rodriguez deals with the complications of vaginal slings made of mesh.
Dr. Rodriguez, who reviewed 28 published series on slings, finds complications include bowel perforations, nerve injuries, vascular injuries, bladder perforations, bleeding, and abscesses requiring drainage.
“Devastating complications involving urethral and bladder perforations can present with mild urinary symptoms and are likely under-diagnosed and under-reported” she writes in her 2007 article in Neurology and Urodynamics.
“A major problem is the lack of a national registry for all slings performed in the United States and therefore we lack a true denominator in determining the incidence.”
The huge discrepancy becomes clear when you look at the literature and compare it to the FDA’s database of adverse events (MAUDE).
“There are four times as many major complications in the FDA reports as compared to the literature. In addition, 10 deaths were reported in MAUDE and none in over 11,000 cases in large published series.”
“It can certainly be argued that the denominator for MAUDE may be 20-fold greater than the 11,000 + cases included in our analysis of the literature. Unfortunately it is the literature that most doctors look at when gathering information on complications.”
“The under-reporting of major complications of sling procedures is likely a result of surgeon experience, referral patterns and failure to diagnose.” She urges more awareness about the nature and symptoms of tape-related complications for prompt diagnosis and appropriate postoperative management.
She concludes that “Stress urinary incontinence has emerged as a highly prevalent medical condition and, as such, has created a large and competitive marketplace for new age, commercially available slings."
Dr. Richard Miller
Dr. Richard Miller is a Professor of Surgery, Medical Director, Trauma Intensive Care Unit, Division of Trauma and Surgical Critical Care at Vanderbilt University Medical Center inNashville, Tennessee.
He sees abdominal wall hernia repair patients after they’ve had complications with synthetic mesh, some made out of Gortex or Marlex.
“The problem with synthetic mesh is as a foreign body the body tries to reject it and encapsulate it. You can bathe it in antibiotics, but the bottom line is that has to be removed and start over again. Because it’s a foreign body you have to be a lifelong risk" he tells IB News.
The key to minimizing that risk, Miller believes, is in patient selection.
“Smoking is the worst. I will not operate on a patient who continues to smoke. Diabetes, obesity, malnutrition, all increase the risk of wound infections. I don’t use synthetic mesh in any of those patients,” he says. Even prior infections increase the risk of a bad outcome.
“It never made sense to put a foreign body in a person to repair abdominal wall reconstructions. “Synthetic mesh, they never feel the same,” he says noting that Ethicon worked hard to create a material that didn’t have an inflammatory reaction.
For the patients who Miller rejects, a cadaver or pig skin mesh is a better alternative. But there’s the cost. “Synthetic may cost $1,000 to $10,000 for biologic mesh. Hospitals decide what material to use based on cost efficiency,” he says.
Dr. Miller says hernia repair complications can occur in up to 40 percent of patients, based on his experience that he admits is a “skewed group, obviously”.
“They can erode into the bowel, that’s a half million dollar problem. They can erode through the abdominal wall and into the skin. I’ve seen a couple of circumstances when you remove the synthetic mesh the symptoms resolve. And many do fine.”
Miller too encourages the establishment of a national database to support his theory of patient selection. Over the next decade he predicts that biologic mesh material will be refined to form a scaffold that incorporates the body’s own tissue and allows it to incorporate immediately.
“My goal is to help these patients and a lot have huge problems. I’m not here to bash synthetic mesh but in certain subgroups there is a better alternative. Certainly, absolutely, they should not be used."
Dr. Denniz Zolnoun
Dr. Zelnoun is an assistant professor at the University of North Carolina, Chapel Hill in the Department of Obstetrics & Gynecology, division of Advanced Larascopy & Pelvic Pain.
She says her job has become “damage control,” and she’s seeing so many new cases in the last six to seven months that their intake form has added a new category, “post-mesh pain”.
Dr. Zelnoun believes pre-packaged mesh kits are leading to the problem. The prevalence of kits means doctors are not measuring according to the anatomy of the patient, she says.
For women suffering post-mesh pain, many are suffering scarring and nerve injury. Frequently women are written off as suffering from marital discord.
“In order to solve the puzzle you have to first acknowledge it” Dr. Zelnoun says to IB News.
“But part of the problem is that neurologists don’t often understand a woman’s pelvic region, and gynecologists are often unfamiliar with nerve and mechanical sources of pain.”
UNC is working on nerve blocks to help with the pain, which may be caused by direct injury or by one nerve irritating another in the proximity of the spinal cord. The field has many mysteries and when you combine that with patients who have been convinced that their pain may be psychological or due to marital problems, you have what Dr. Zelnoun calls a “Conspiracy of Silence” that keeps the problem and solution from the forefront.
(Continue reading: Suffering in Silence- Part 4- Lana Keaton, founder Truth in Medicine) #