Check Out Our New Forum!
The Your Turn Forum provides a space where people can post questions about mesh and medical device related issues and get advice and support from the Mesh News Desk community.
Join the Discussion!
Wideman, 57, and her husband Bob, 65, have taken care of 32 kids over the years on their 160 acre farm in Rose Prairie, British Columbia while raising a huge vegetable garden and tending to the needs of a flock of farm animals from lamas to sheep, horses, chickens and up to 50 head of cattle.
At least that’s how it used to be.
Today Nonie (Noreen) takes it one step at a time - literally. The garden is gone. Bob has to do most of the work around the ranch and Nonie says she’s aged greatly in the last few years. Today she says she’s about one-quarter of the person she used to be.
In June 2008, Wideman was implanted with a TVT Secur (TVT-S) synthetic mesh to treat the inconvenience of stress urinary incontinence (SUI), a condition that occurs when weak pelvic floor muscles allow the urethra to sag and leak urine. Twenty years earlier she had her urethra stitched in place using the Burch procedure, considered the “gold standard” for the treatment of SUI before the petroleum-based meshes were introduced to the market in the 1990s.
Over the years with the farm chores – milking, herding, hiking and tractor riding – the Burch procedure had failed so Wideman found her incontinence problem had returned.
“I’m active on the farm. I would like to cough and laugh without peeing my pants,” she told MDND.
Editor note* (Since the introduction of the TVT slings in the late 1980s and the mini sling in 2006, the Burch procedure fell out of favor, however since the FDA warnings about synthetic mesh in 2008 and 2011, one doctor says he has seen a resurgence of the Burch procedure.)
The Gynecare TVT (transvaginal tape) Secur System is made by Ethicon, a division of Johnson & Johnson of Somerville, New Jersey. It is a ribbon-like string of petroleum-based plastic mesh material that is inserted transvaginally (through the vagina) to support the urethra so it remains closed whenever the patient coughs or sneezes, thus preventing urine leakage. The 30 minute procedure is called ‘minimally invasive’ because it’s done on an outpatient basis using small incisions inside the vagina and near the inner creases of the thighs resulting in a quicker recovery time, according to the company.
“The ribbon-like mesh is made from a permanent material that will be well tolerated by your body. It will remain in place to help support your urethra. The rate of complications with GYNECARE TVT is very low.” – Ethicon brochure.
TVT SEcur from Russian website
However there is nothing ‘minimally invasive’ when a permanent mesh implant results in complications, as it does an estimated 10 to 20 percent of the time. The actual complication rate is unknown since there is no postmarket surveillance or patient registries.
“The values that guide our decision-making are spelled out in Our Credo. It is more than just a morale compass; it is what we do business by. Our aim has always been to put the patient first and GYNECARE TVT SECUR™ does just that. It guides us to create more innovative products, which means that the patient not only gets a better quality product but one that also brings them less discomfort. We believe in our credo and we believe in GYNECARE TVT-SECUR™.”
Canada follows the lead of the U.S. in approving synthetic polypropylene mesh, a petroleum-based product. There is no requirement on the part of the U.S. Food and Drug Administration (FDA) to prove safety and efficacy under the 510(k) approval process, which is FDA approval to market. Unlike drugs, which must undergo premarket approval based on clinical trials, mesh and thousands of other medical devices do not face that requirement and manufacturers are required to name only a ‘predicate device’ already being sold that their device resembles.
Public Citizen, Truth in Medicine, Consumers Union and the Institutes of Medicine in a 2011 report, have all requested the U.S. abolish the 510(k) process as a dangerous safety loophole that is putting thousands of unknowing medical consumers at risk of defective metal-on-metal hips, defibrillator leads and synthetic mesh.
In February 2010, Health Canada, warned consumers about the potential dangers of transvaginal mesh.
“Reported complications associated with the use of transvaginally-placed mesh for the treatment of SUI and POP include erosion (vaginal, urethral), pain including dyspareunia, infection as well as perforations and other injuries to adjacent organs including the bowel, bladder and blood vessels. Risk factors associated with these complications are not completely understood but may relate to both patient-specific factors such as age, overall health status, estrogen status and a history of previous surgery in the area as well as procedure-specific factors such as surgical technique and route of mesh placement. Required treatment for these adverse events varies depending on the complication but can involve surgical intervention including complete mesh removal.”
The Health Canada warning falls far short of the warning issued one year later in July 2011, by the U.S. FDA when consumers and doctors were told that the risks of transvaginal mesh likely outweighed the benefits.
Wideman travelled to Fort St. John, British Columbia to a gynecologist who had scheduled a polyp removal from her cervix. She decided to take care of the SUI at the same time. At first the TVT-Secure worked. There was no pain and Wideman thought the procedure was wonderful but over the next three years her health took a mysterious downtown.
After six months, the incontinence returned. When a sheep tore her Achilles tendon, Wideman ended up hospitalized for a repair. Surgery was scheduled and after a severe infection developed her entire leg swelled to almost double its size above the knee. It took two months of antibiotics to return the situation to normal.
She also found out she was anemic.
“I think I was experiencing a foreign body response. Not only did I end up with severe infection but I was chronically anemic and tired. I didn’t realize what was going on. I didn’t realize my immune system was exhausted. I just felt like I was getting old really fast.”
Her asthma, which had been controlled with an occasional inhaler, flared up and became more severe requiring a trip to an emergency room and the addition of steroid medications to ease the swelling and inflammation in her lungs. She got the flu and pneumonia at the same time and Wideman got her first bladder infection in 30 years.
“I thought what the heck is going on. My bones ache and I’m cranky, this is not me. My energy level slowly dropped, and I ached all over. My ability to handle chronic depression with medication dropped and my anti-depressant medication was doubled,” she says.
Wideman had suffered depression on and off for years, but managed it with medication.
In June 2011, Wideman says she was awakened by a horrendous pain through her rectum. As she was about to go on holiday, she spent 16 hours driving but upon arriving in southern British Columbia she was taken by a family member to a walk-in clinic. Wideman remembers the female doctor used a speculum to look into the vaginal vault. She couldn’t find anything wrong. You must have pulled a muscle from kegel exercise, Wideman was told.
“After the exam the pain increased. I didn’t sleep until 4 a.m. and I’ve got a really high tolerance for pain. I walked on a broken foot for three days. This was pain that never let up.”
Every time a doctor wanted to do a pelvic exam using a speculum, the pain increased until it felt like a knife was being used instead of a plastic device. Wideman says she finally Googled her symptoms over the internet and she says they all came up mesh-related. Could it be the mesh? She did a self-exam and felt the corner of something poking into the vagina.
“Once I researched the side effects I thought Holy Moses, my immune system was probably fighting this all along and it would explain my deteriorating health. I felt like an 80-year-old with no energy. I’d fall asleep during the day; I’m afraid I’m going to drive off the road.”
She was prescribed oxycodone for the pain and estrogen cream for relief.
Around this time Nonie was being recognized for her beautiful, intricate watercolors of animals and nature. She had sold prints and greeting cards and was trying to finish two painting for a gallery show but sitting was so painful and she couldn’t finish.
“It was such good therapy. I surprised myself and found hidden talent, it seems when God closes one door he opens another so I started to pursue an art career.....which came almost to a shuddering halt when I lost the ability to sit for more than a few minutes at a time comfortably,” she says. “I’m kind of meshed and messed up, but I will not quit. It is just going to take me a lot longer.
"The many ways mesh has shortchanged me is heartbreaking.”
Polar Bears, by Nonie Wideman
After that, it was a slow developing nightmare, and she says her story is almost a repeat of every other transvaginal mesh victim.
Nine doctors later, family and friends had to do a suicide watch over her.
With a burning up her urethra, Wideman says the pain was moving higher. Knowing something was going on, she acted now as her own investigator and strained her urine midstream and adhered the particles with tape to a piece of white paper. There she found clear examples of a blue filament, evidence the mesh was eroding into her bladder.
She showed her find to an emergency room doctor but she says he wouldn’t even look at it.
Finally, in pain, throwing up and with high blood pressure and an inability to stand, Wideman and her daughter-in-law made an emergency flight to the head of obstetrics and a professor at the University of British Columbia. Not able to leave the vicinity of a toilet, she had also lost control of her bowels.
”It was humiliation on top of pain,” she says.
Straight to St. Paul’s Hospital, she was red and sweating and in agony. It was her sister who said “absolutely not” when someone insisted on a pelvic exam. “She told him do not touch her, do not examine her. If it’s crystallized, you are breaking it up. Keep her comfortable until she can see the doctor.”
Five days later the doctor who finally did the examination confirmed the blue fibers taped to the white card were polypropylene which was causing her grief. The mesh needed to come out. A foreign body response to the mesh is among the complications for about 25 percent of patients who have mesh, she was told.
When a wait of three months wouldn’t work, Wideman’s emergency removal surgery was scheduled for two weeks.
The doctor told Wideman he had successfully removed all of the mesh that was intact but the fibers remained behind. Even the burnt pieces where the mesh had been cauterized were found coming out in her urine months after the surgery.
Today Wideman suffers chronic inflammation and feels she knows where the damage is. She says it feels like a bladder infection and higher. Taking 200 mg Tramadol a day slow-release has helped but Wideman says she still has burning and inflammation as well as low pelvic pain and low back aches.
On April 18, 2012, CTV-News in Toronto did an initial news story then a follow-up about mesh complications after a first report generated a huge viewer response.
In the report, a doctor interviewed said the complication rate was low, from one to five percent.
In that segment, Wideman told her story of advocating for herself and finding the blue haze of mesh that she would pick out from her urine on the end of a pin. Many of the women who contacted her afterward said they thought they were the only ones and that they’d been told their complications might be due to aging. Wideman is now trying to bring help to those women in smaller Canadian communities who she says are not getting the standard of healthcare.
“If you don’t have hope you may as well take sleeping pills and die that’s how painful it is and devastating. I can’t let them get to that place.”
“To me the doctors who did my removal surgery are like angels. But there are too many doctors who seem to be uneducated about mesh complications leaving women to suffer as if they were in a Third World country without a knowledgeable medical system.
“I hope that putting faces to these injuries will help expose the horrendous treatment of women to those who have the power to stop a terribly risky procedure using medical mesh that is not inert, that is not non-allergenic, and has not been tested adequately to be deemed worth the risk in its applications.”
Wideman is represented by legal counsel in Canada who plans an individual action on her behalf as opposed to the class action that’s amassing hundreds of defective product cases from across Canada.
Her attorney, Paul Miller, had five cases last November. Today he has 75 with more cases pending. #
*Post Script: Wideman says she believes the government is not looking after patient interest and it’s shameful women have to advocate for themselves from a grassroots level.
“If there was mandatory reporting of medical mesh complications they would have caught this years ago,” she says. Sending a report to the Health Canada on her own situation got her no response. She has begun a petition in Canada to make mandatory reporting of medical mesh complications. #
Wideman’s Letter to Health Canada
http://www.hc-sc.gc.ca/contact/index-eng.php
Wideman’s Petition
CTV News, April 17, April 30, 2018
http://www.ctv.ca/CTVNews/Canada/20120417/transvaginal-mesh-women-lawsuit-incontinence-120417/
http://www.ctv.ca/CTVNews/Health/20120430/transvaginal-mesh-incontinence-women-120430/
Here is notice of the class action lawsuit in Canada- April 17, 2012 -
http://www.newswire.ca/en/story/956349/transvaginal-mesh-class-action-commenced-in-canada
Health Canada, February 4, 2010 – Complications Associated with Transvaginal Mesh
U.S. Food and Drug Administration, July 13, 2011 – Safety Notification on Transvaginal Mesh
http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm262435.htm
Fine Art America- order Nonie Wideman Prints
http://fineartamerica.com/htmlprofiles/nonie-wideman.
Background on suburethral sling procedure, Global Library of Women’s Medicine 2008:
http://www.glowm.com/index.html?p=glowm.cml/section_view&articleid=68
Ethicon: Women’s Health Solutions
Clinical information about the Gynecare TVT Secur
http://www.ethicon360emea.com/products/gynecare-tvt-secur-system
Although the initial results for GYNECARE TVT-SECUR™ are very promising, follow up is still in the early stages and more long-term studies will need to be completed to assess the long term efficacy and safety of the product. It does however; offer the platform for a less invasive procedure with potentially the same clinical success as attributed to GYNECARE TVT™.
UroToday- TVT-Secur: One year data from a Multi-Centre Prospective Trial, January 26, 2009
http://www.medicalnewstoday.com/releases/136635.php
A trial of 95 patients with SUI, in an 18 month follow-up found 78% were cured by the procedure the cough stress test was negative in 81%, with 8% having voiding difficulty, 10% with recurrent urinary tract infection and denovo urgency incontinence at 10 %. Along with dyspareunia and vaginal protrusion of the mesh in two patients. Eight out of the 20 failures underwent a new procedure within the first year of follow-up.
European Association of Urology, Department of Urology, Tenon Hospital, Paris July 2010, Midterm prospective evaluation of TVT-Secur reveals high failure rate
TVT-Secur was heralded as the new minimally invasive sling for SUI management and showed promise short term. However this evaluation was for midterm follow-up at 11-40 months. While the short term evaluation showed a 93.5% success rate, at the follow-up only 40% were cured while 18%were improved and 42% failed.
"CONCLUSIONS: Our experience shows that despite its good short-term efficacy, TVT-Secur is associated with a high recurrence rate of SUI. Therefore, TVT-Secur does not seem appropriate for SUI first-line management in women."
Miklos and Moore: Burch Procedure video
