Surgeons Blind & Dangerous
Surgeons need to see what they are doing! They should not be doing these procedures without a camera to guide them.
I woke up this morning remembering four years ago today. My daughter Kim and I were at the surgery center very early in the morning because I was first in line that day to have my mesh removed. I was very anxious and yet I was so glad that day had come at last because I had hoped that the quality of my life would improve. To this day I have never regretted selling things to get out to UCLA to have the removal done by Dr. Raz. Without going I am sure by now I would be in a wheelchair and the quality of my life would be desperation.
I have written so much about the outcome of my surgery and the fact that I remain disabled. There is a good reason for this and the FDA has stated that the procedure itself is blind, the tools need redesigning and yet these same kits remain in operating rooms all over the U.S and around the world. This means more women like me will stop living the way they used to.
Perhaps to the mesh manufactures and the doctors, the percentages of women who are permanently injured is the price of doing business. But that price is horrendously far too high. In a moment I will give you some of what was written on my operative report that day of my surgery, but before I do, these are just a few of the PROBLEMS WITH THESE SURGERIES AND THE PERCENTAGES OF WOMEN WHO INJURED. However, there is no proper data base nor records kept by doctors to give the proper and correct reports on percentages and I doubt there ever will be. Even if there was, I doubt that doctors would add women into it because they prefer to pretend that none of this happens to THEIR patients. Without a true picture of adverse effects, this will continue and more women will be injured for life. This only relates to nerve injury. Now read this which comes from the latest FDA report.
Nerve injury and pain events include adverse events such as nerve injury, nerve damage, leg pain, thigh pain, buttock pain, and neurological symptoms.
Please see Attachment 8 for a table of vascular injury and bleeding outcomes from the published literature.
For adverse events related to nerve injury and pain:
•SUI, retropubic procedures: 5 of 74 references reported adverse events, with rates between 0.1-5.3%.
•SUI, transobturator procedures: 11of 65 references reported adverse events, with rates between 0.8-30.8%.
•SUI, mini-sling: 5of 32 references reported adverse events, with rates between 1.1-4.1%.
•POP, transvaginal repair: 15 of 33 references reported adverse events, with rates between 6.0-39.1%.
•POP, sacrocolpopexy: 1 of 3 references reported adverse events, with a rate of 14.9%.
Overall, the review of the published literature demonstrates that adverse events can occur as a result of
urogynecologic surgical mesh instrumentation and at potentially high rates. These data support the
need for well-designed instrumentation evaluated to ensure adequate performance, specifications, and labeling.
Risks to Health and Proposed Mitigations
In the May 1, 2014 513(e) proposed order, the FDA identified the following risks to health associated with urogynecologic surgical mesh instrumentation:
1.Perioperative risks. Organ perforation or injury and bleeding (including hemorrhage/hematoma).
2.Damage to blood vessels, nerves, connective tissue, and other structures. This may be caused by
improperly designed and/or misused surgical mesh instrumentation. Clinical sequelae include
pelvic pain and neuromuscular problems.
3.Adverse tissue reaction. This may be caused by non-biocompatible materials.
4.Infection. This may be due to inadequate sterilization and/or reprocessing instructions or
At the end of this blog, I will give you the link to the last blog I wrote about the latest report from the FDA in February 2016, just this year. However, six years and seven months ago when I was implanted with a mesh sling, none of this had been said and there was no warning that I could find anywhere on the Internet. I was NOT giving a pamphlet, nor was I told about the dangers of this surgery, in fact this was totally ignored by my implanting doctor. Even now, doctors are DOWN PLAYING the dangers of these implants and they continue doing these surgeries every day.
You may think that just because your got through your surgery okay and you are living life again, that there is no danger to your future. However, you would be so wrong. Even if the FDA stated that EVERY doctor had to begin a data base and keep a record of those who have been implanted, it will only cover 5 years. I know all too well that women have suffered far later than that, often 7 to 10 years and even as long as 14 or 15 years. So this data base should be the lifetime of a woman who has been implanted and yet I know this will never happen.
Now I am going to let you read a little bit of the extensive operating report from my removal surgery. You should know that my implant was a Boston Scientific Advantage Fit TVT sling. According to my implanting doctor, the TVT sling could not cause this kind of damage. How wrong she is!
“The mesh was dissected with a very difficult and delicate dissection from the urethral wall itself”. I had suffered so long from infections and pain and I had a great deal of difficulty urinating after the implant. I had to self-cath for months, not just after this surgery, but after two other reconstruction surgeries several months later. The damage the implant did to my urethra is permanent and I have to live with continuous problems and difficulties doing something as normal as “going for a pee”.
“The mesh attachments to the bladder wall and urethral tissues were also dissected free”. If you have not had this surgery you may not realize that along with removal of mesh, some of the tissue is also removed because the mesh is designed to ‘granulate’ which means ‘to grow and stick’ to your bladder, so removing it becomes very complicated.
“The mesh in the right side as mentioned practically penetrated the urethral wall and it was a difficult and delicate dissection to free it from the urethral wall”. The damage was done and Dr. Raz had to remove part of the urethra and repair the tiny tube that allowed me to empty my bladder. This image below will show you how long the urethra is.
3.5 centimeters long, is approximately 1 ½” long. Once you cut away part of it, there is a higher risk of continuous infections, but to remove the mesh, from my urethra there was no choice.
There was also a great deal of explanation as to how it was removed on both sides, right and left and the reasons why I had complained of continous pain. At the very end of the report, this was stated.
“This was a very difficult, extensive and complex reconstruction. The mesh removal required abdominal and vaginal exploration, dissection of the mesh from the pubic bone and deep penetration from the urethral wall envelope under the mucosa.” Dated 11th October 2012.
The pain it caused to both my nerves and muscles has lessened since my removal surgery, but it remains so that I walk in pain and need walking sticks to get around.
I can’t change what happened to me, but I have done everything in my power to warn women so that they know what doctors DON’T tell them could happen at the time of surgery.
If you need surgery, then be sure you check out what the hospital operating rooms keep on their shelves before you go. Instead of mesh, search high and low for a doctor who can fix your problems the way they used to, before mesh kits became so popular and every doctor, ‘Tom, Dick or Harriette’ began practicing on women. I for one hate being an injured statistic for the rest of my life.
This blog will tell you all about the latest report from the FDA. http://www.meshangels.com/the-fda-injured-women/
If you live in Europe, this blog will tell you what countries in Europe are thinking about mesh implants. http://www.meshangels.com/europes-stand-on-mesh/