Jane Akre recently posted on the MDND blog an article entitled, “FDA: Stress Urinary Incontinence (SUI) Surgical Mesh Reports up 36 Percent”, which reads:
While advising not every woman experiencing SUI will need surgery the FDA appears to endorse sling surgery over non-mesh repairs on the What is Stress Urinary Incontinence? page (here) by saying:
“The use of surgical mesh slings to treat SUI provides a less invasive approach than non-mesh repairs, which require a larger incision in the abdominal wall. The multi-incision sling procedure can be performed using three incisions, in two ways: with one vaginal incision and two lower abdominal incisions, called retropubic; or with one vaginal incision and two groin/thigh incisions, called transobturator. There is also a “mini-sling” procedure that utilizes a shorter piece of surgical mesh, which may be done with only one incision.”
This article goes on to say:
Mesh sling surgeries for SUI have a reported 70-80 percent success rate at one year. A similar rate of success is reported at one year for non-mesh repairs. The FDA page does not say what constitutes “success.” As we’ve learned from testimony in the Linda Gross trial, success is sometimes defined as the correct placement of a pelvic organ and not the quality of a woman’s life after the surgery.
The most common complications coming into the FDA for surgical mesh slings for SUI repair, in descending order of frequency, include:
“pain, mesh erosion through the vagina (also called exposure, extrusion or protrusion), infection, urinary problems, recurrent incontinence, pain during sexual intercourse (dyspareunia), bleeding, organ perforation, neuro-muscular problems and vaginal scarring. Many of these complications require additional medical intervention, and sometimes require surgical treatment and/or hospitalization. With the exception of mesh erosion, the above complications can occur following a non-mesh surgical repair for SUI.”
The FDA suggests partial removal may be a remedy.
My reaction to all this? Outrage.
I can not believe they are still advocating the use of mesh for SUI or POP. Both are causing horrific and well-reported complications!! How many lives have to be destroyed before they finally say “Enough!”.
Using mesh for SUI is simply wrong. Since when is it ok to let the risk of the surgery outweigh the original problem? Lets face it, while SUI is a problem, it is NOT nearly as bad as the complications that mesh complications may very likely impose. Why take that risk? Especially when there are alternate methods that do NOT have such terrible risks?
Sure, every surgery has risks, but the risk of using mesh implants go way above and beyond normal risks that any surgery imposes. Traditional surgeries using your own tissues may have risks of failure – so does mesh! And, the FDA report even said that there is no evidence that mesh worked any better than traditional non-mesh repairs. They also would not pose the risk of FBR and mesh eroding through vaginal walls, organs, tissues… etc.
So WHY keep using mesh??? Greed. Money. I didn’t want to believe that… but, the more I learn, the more I can not come to any other conclusion. It seems to me that this is all about marketing, disguised as helping people. It’s all about making money, and NOT about what is best for the patient.
They market this as less invasive. Quick. Easy. Safe. Lets face it – we like “quick and easy”. “Quick and easy” sells! We don’t want to have to interrupt our lives, and time is always a factor. I was worried about taking time off a couple of days of work for my surgery. Now, I’m on disability and haven’t worked in months, I had to make 3 trips to UCLA for treatment, and have months more of recovery (hopefully!) ahead of me. So, how is THAT for “quick and easy”?
What good is “quick and easy” if it results in poor quality of care?
- What good is it to be sent home the same day, if it then creates years, or even a LIFETIME of problems afterwards??
- Why don’t they tell you about how serious the complications will be if there are complications?
- Why don’t they tell you how common those severe complications are?
- Why don’t they tell you how there are no “less invasive” and “quick fixes” if you are one of the MANY women who wind up with mesh complications? Matter of fact, you will have trouble finding anyone who can really help you!
Call me crazy, but I would rather have a scar on my stomach with a longer recovery in the hospital using the traditional NON-mesh surgery for SUI repairs – then to use mesh in order to go home the same day, but also have the HUGE and often PERMANENT life-quality-threatening risks that go with it. I wrote about this in another post, “Mesh: Definitely risky for POP, but for SUI? Eh? It might be ok still, right?“.
I am 46. My life has completely turned upside down since I had my mesh sling for SUI put in last year in Feb 2012. I have been limping around for over a year in pain, and using pain pills. Even with the pain pills, I hit the point I couldn’t walk without a crutch in July 2012. I am still using it. In addition to missing work, I have missed almost all of my children’s events this past year. I can’t walk my dog or take care of my usual responsibilities. I can barely take care of myself let alone my family and house. Everything is a struggle.
This past January, I went all the way to UCLA to have the mesh REMOVED. I could not find a doctor locally who could help me. I had to make three trips for this all the way across the county. Now, that the mesh is out, some of the constant pain, that felt like a steak knife stabbing in my groin from the inside, is gone. I am a little better, however, I am still in major pain. Still using a crutch and pain meds. I will start PT and Chiropractor treatments soon, now that my incisions are finally healed. I hope that I will be one of the few lucky ones to actually make a full or close to full recovery from mesh complications, but, I can’t know that yet. I’m looking at months more of recovery before I have definite answers. Uncertainty has become the norm for me. I am determined, though. I am not ready to be disabled the rest of my life even though I know that is a possibility. I know that if that happens, I am sadly and certainly NOT alone.
For now, I am focused on healing. I have young kids, a husband, a life with lots of things to look forward to. It sure would be nice if I could actually DO them. I do have a lot of hope, especially since I was able to get all the mesh out by one of the best surgeons alive (Dr. Raz), and in a relatively short (compared to most) time period after it was put in. No matter what happens, I know that I am one of the “lucky ones”.
I’m lucky because successful full mesh removals, as well as “hope”, are luxuries many women with mesh complications do not have. Many suffer for years longer than I have, with much worse complications – severe, life-altering complications from mesh used for SUI, POP, and even Hernia mesh. There are thousands of injured people out there and more keep surfacing – yet they STILL KEEP PUTTING THIS CRAP INTO PEOPLE left and right. ?!?!
It is so NOT right. It’s sad. It’s even more upsetting that our system is allowing this to continue… and there are many hands in the pot that are enabling this disaster to keep happening. Hands that we should be able to count on to help us, to protect us, but sadly that trust is being broken… repeatedly. I’m just sick to death over the whole ordeal.
This is a video of my friend, Jay Lee, with Rep. Markey in a press conference calling for the end of a dangerous loophole at the Food and Drug Administration which has allowed faulty devices to stay on the market. This was in March of 2012. Click here for article.