Thumbs Down, iStock photo

According to a report issued today, November 7,  by Millennium Research Group (MRG), the market for pelvic floor reconstruction vaginal slings is predicted to decline significantly. See the report here,  and the Press Release here:

The industry has experienced steady growth for the past several years due to aggressive marketing to the Baby Boomer generation, the target audience for pelvic organ prolapse and urinary incontinence vaginal slings. MRG does market research and provides strategic information to the healthcare industry.

According to MRG several factors are softening sales by more than 15% in 2011 to under $115 million:

• Poor Clinical Outcomes

• FDA Public Health Notice (actually one in 2008 another in July 13, 2011)

• Lawsuits (hundreds at the least, possibly running into the thousands and not just in the U.S. but in Canada and the UK)) will make surgeons less likely to use the devices and patients less likely to request them.

Synthetic Mesh

The synthetic market is more affected than biologic mesh made from animal skin primarily because the FDA’s warning mentioned only the nonabsorbable synthetic mesh which is synthetic.

Boston Scientific, Ethicon and American Medical Systems should expect significant losses.

The research group predicts a  7% slip in sales for vaginal slings in 2011. Interestingly, MRG predicts negative publicity will fade by the year 2014 and the vaginal sling market will recover.

All of this is good news for Cook Medical which makes a biologic mesh without prolene, and is differentiating itself from synthetic vaginal prolapse mesh.

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Jane Dowdall

Jane Dowdall, 55,  is from  Ontario, Canada and tells her own story of bladder prolapse repair and her life today.

“In early 2009, I was referred to an Ob-Gyn for a bladder prolapse repair. During my pre-op appointment he explained that he would be using stitches for the repair, but since there was a good chance that following this surgery I may experience increased incontinence, I may want to also have a procedure that looked after that at the same time. Since I did have minor SUI (stress urinary incontinence) prior to the surgery, I agreed to the additional procedure.

“The Ob-Gyn sent me to a colleague who would perform the incontinence prevention part of the surgery. At my pre-op appointment with this Ob-Gyn, he quickly stated that I would be having a TVT-O but said nothing about possible risks or side effects. After leaving the appointment, I checked the Internet for more information on this procedure, but there was little available. Had I known then what I know now, I would have NEVER agreed to this procedure.”

Two Doctors?

“The next time I saw both doctors was in the O.R. on May 15, 2009. It did seem rather strange having two Ob-Gyns in the O.R., and I often wonder if one was learning from the other.

“Immediately after surgery I was experiencing pain and had difficulty urinating but attributed this to post-op symptoms. However, during the next couple of months the pain and urinary retention worsened. The pain radiated from my upper thighs to my navel, feeling much like a migraine headache, along with a burning and stinging sensation. Sitting, especially at my computer at work, was becoming unbearable.”

Out of Her Mind with Pain

“I visited the first Ob-Gyn and he ordered a pelvic ultra sound that indicated I had 63% bladder retention. He said the symptoms I was experiencing were not from ‘his part’ of the surgery and referred me back to the Ob-Gyn that performed the TVT-O.

“When I finally got an appointment in September, the TVT-O Ob-Gyn said he had not come across any problems with this procedure in the past, but would ask a colleague what it might be and that perhaps it was too tight. In the meantime he ordered another pelvic ultrasound. At my next appointment in October, he said I had an acceptable level of 20% urine retention, even though I was still having trouble urinating. He was still very puzzled by the pain I was experiencing and prescribed Celebrex and sent me on my way.”

Body Rejecting TVT-O

“Unable to work a full day due to extreme pain, I visited my family doctor who prescribed narcotic pain medication and referred me to a local Urologist. After a cystocopy that did not reveal erosion of the TVT tape or bladder tears, he felt my symptoms were consistent with TVT mesh rejection. He stated this was very rare and that he could not remove the mesh at this point. I was devastated!

“It wasn’t until I stumbled upon a newspaper article on the Internet from the Hamilton Spectator about a woman experiencing identical symptoms as my own, that I realized I was not the only one with an adverse reaction to this surgical mesh. Obtaining my hospital records, I discovered I had had the Johnson & Johnson Ethicon Gynecare TVT-O made of Prolene Polypropylene.

“By January 2010, the Tramadol and Tylenol 3 could no longer control the pain and I was unable to work. Other ‘nerve’ drugs were tried but I could not tolerate them. The local Urologist found a Urologist in Toronto who had experience in mesh removal and I was given a referral.”

Dr. L. Carr in Toronto

“In July, 2010 I had an appointment with Dr. L. Carr in Toronto, a very caring doctor who is extremely sympathetic to mesh issues. She said that only the center section of the tape could be safely removed due to the manner in which TVT-O is anchored and that there may be a reduction in pain but there was no guarantee. I appreciated her honesty. Feeling it was better to have the majority of the mesh removed to decrease chances of future erosion, I had removal surgery in August 2011. There were two other mesh removal surgeries that day, one lady traveling all the way from British Columbia.

“I am now able to urinate normally but have not had a decrease in pain. I am experiencing new stinging sensations that apparently could be caused by the ‘arms’ or ends of the mesh rubbing on surrounding tissue.”

Health Canada Warning

“What angers me is that I spoke with a nurse who just had the TVT-O procedure by the same Ob-Gyn that performed by my surgery, and when she inquired about possible risks or side effects, she was told there may be some post operative discomfort but no risks/side effects that he was aware of, even though on February 4, 2010, Health Canada issued a bulletin, (see here) similar to the FDA’s bulletin, warning of complications associated with transvaginal mesh. She is now experiencing problems similar to mine.

“It has now been almost two and a half years since the initial TVT-O surgery.  I am in constant pain and unable to work. I have been on Long Term Disability for over a year. In order to get through the day I must take narcotic drugs.  I spend most of my time in a reclining position, in loose fitting clothing, and I seldom leave the house.  I have filed a report to Health Canada without results.”

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