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"Transvaginal Mesh Is Life-Threatening"

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Miami, FLMedical consultant and analyst Lana Keeton believes that transvaginal mesh, like other synthetic surgical mesh (e.g., Kugel mesh), should never have been put on the market. "Synthetic Surgical Mesh is a life-threatening device," Keeton says. "It is toxic, over-engineered and degrades during manufacture, shelf life and in the human body following surgical implantation."

LawyersandSettlements (LAS): Why do you believe that transvaginal mesh, or any surgical mesh is life-threatening?

Lana Keeton (LK): Synthetic mesh is a misuse of the body's inflammatory process. The tension-free concept is for human tissue to scar into the interstices of the mesh to hold it in place following surgical implantation. The concept is flawed as the final result of implantation is never known as there is no clinical data to support this. And despite processes used during manufacturing process, polypropylene leaches nonylphenol.


(LAS): What is nonylphenol and why is it dangerous?

(LK): Nonylphenol is an endocrine disruptor and has an estrogen effect. It causes thymocyte apoptosis, which can result in auto-immune disease. It is an endocrine disruptor showing estrogenic activity.

According to the EPA, nonylphenol is toxic to aquatic organisms. EPA also intends to propose a new regulation in 2011 that would require any company that wants to use NPEs or nonylphenol in new applications to notify the agency before doing so. Plus, federal regulators will consider adding nonylphenol and NPEs to the list of chemicals of concern that might present an unreasonable risk to human health or the environment.

(LAS): How is surgical mesh physically dangerous?

(LK): Synthetic mesh degrades continually, starting with the thermal knitting during manufacture, in the package on the shelf and inside the human body. Dr. Bruce Ramshaw presented his findings on hernia mesh explants to the CDRH/FDA, demonstrating how mesh hardens, shrinks and deforms while implanted. This is in addition to scar contracture caused by the actual surgical procedures to implant the mesh. Mesh/tissue integration is ill- defined in the literature and in clinical trials.

(LAS): Are you saying that this tape and the medical device "Transvaginal Mesh Sling" or TVT is defective?

(LK): Yes, without a doubt. The Gynecare TVT System and its TVT Device (Prolene mesh tape) are inherently defective for more than one reason. The tape itself has abrasive edges that cut human tissue to sensitive organs like the bladder, the vagina, the urethra. It is a process that will not stop unless your doctor surgically intervenes in some manner. I have reports from an expert witness that the edges of the tape are defective.

The plastic sheaths that cover the tape for the purpose of implanting it in your body have to be pulled out after the tape is put inside you. Any movement of that tape after implantation is undesirable based on a patent that Ethicon filed in 2004.

(LAS): What happened with the Ethicon patent?

(LK): This patent shows that the first tape implantation didn't work. Ethicon edges caused the problem so the company tried to change the edges; they were stabbing in the dark to try and make it work but nothing can make it work because it's a bad product, just like Kugel mesh. Whether this synthetic mesh is used for hernia repair or POP and bladder suspension, it's all the same product and all bad.


(LAS): If transvaginal mesh is life-threatening, why are doctors routinely implanting it in patients with Pelvic Organ Prolapse (POP) and/or Stress Urinary Incontinence (SUI)?

(LK): It is frequently described as the "new gold standard" because it is popular, not because it has been proven safe and effective.

Doctors are misled by rosy medical marketing by the manufacturers showing high cure rates and very low complications. (There are no randomized controlled trials to support these numbers, just press releases from the makers of the mesh.) Patients are told nothing. Frequently they do not even know mesh has been implanted in them. If they do know the doctor has used mesh, there is no readily available information telling them exactly what kind of mesh has been permanently surgically implanted. Patients are left in the dark.

(LAS): What kinds of problems with this mesh are being reported?

(LK): Short-term complications include infection and urinary retention, while long-term complications are de novo urgency and urethral and vaginal erosions. As I said (above), it can result in auto-immune disease.

(LAS): If problems do develop, what is the prognosis?

(LK): Future medical treatment for the serious complications of mesh becomes a mine field. The body's own natural inflammation process, by which the surgical mesh adheres to internal tissues, never reaches the healing phase. A cascade of complications follow as chronic inflammation sets in. Auto-immune diseases multiply as the body fights the chemical leaching of nonylphenol from the polypropylene meshes. Other synthetic meshes, all petroleum based, create havoc in the body as they leach their own proprietary blend of chemicals.

(LAS): What kind of procedure was in place to treat POP before TVT was introduced?

(LK): Skin grafts were implanted but they didn't have a great success rate—what can you expect when you are trying to sew weakened tissue?

Let me explain it this way: You have holes in a threadbare bed sheet. You place a patch over the hole and sew it to the threadbare material. That patch will pull away from the sheet because it is too strong for the sheet. If that is the problem, doctors will just get a bigger patch. Instead of a 4" x 4" piece of mesh, they will use a 10" x 10" piece, and that is literally torture.

All problems that require mesh, such as POP, are symptoms of weakened tissues, not diseases. So doctors are trying to treat the symptoms. Instead, they need to strengthen the tissue—not fix the hole. They need to use biologic mesh that functions with the tissue and is not cross-linked; it is constructive remodeling that promotes your own tissue.

(LAS): Why would doctors use synthetic mesh rather than biologic mesh?

(LK): Biologic mesh is more expensive and the doctor needs greater surgical skills and training in order to constructively remodel with biologic mesh. (But there have been problems with biologic mesh.)

This question goes back to promotion and marketing by the drug industry: Doctors who would have never considered this procedure are now emboldened by these mesh kits and do procedures they wouldn't have thought of doing in the past.

The bottom line is that TVT should never have been put on market. It is the same design of mesh that is being used in the abdomen. The premise is that mesh doesn't move in the abdomen because it is flat. But pelvises are used to walk, sit, have sex—a pelvis moves, and having this TVT implanted is a very bad move.

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READER COMMENTS

Posted by

on
I had bladder mesh in 2011, have been sick ever since now I have auto immune disease ...I'm having mesh removed tomorrow ..I hope my health improves as my life at the moment is terrible

Posted by

on
I'm in Australia and had the mesh implanted in me in 2009. Since then, besides experiencing a lot of pain, I have also gained many unexplained illnesses. One of them is becoming allergic to the Sun and UV rays. Within 5 minutes of being out in the sun, I start to itch, go red then come up in bubbles. Its so painful. I have to take medication to help it stop. I can't walk to the shops, hang clothes on the line, go outside or do my gardening or anything. I use to be very sporty before the operation, now I'm so tired, sore and depressed, I don't know what to do. I have even thought about taking my own life on many occasions. I feel so alone in this. I'm at the doctors all the time, and I'm sure they think I'm crazy. There needs to be a support group!!!! This mesh has wrecked alot of lives, and continues to do so. I'm trying to find a doctor in Sydney to remove the mesh, but even that is proving hard. No one wants to know, but they are happy to take your money....... :(

Posted by

on
I had a hysterectomy and bladder sling in 2008. No problems.
But in 2011 I developed sudden onset of Polymyalgia (auto-immune disease) with severe pain in hips and shoulders. Prednisone helped relieve the pain. But then I have been left with chronic tiredness and especially "brain fog" and pressure in my head.....which leave me quite miserable. My urogynecologist says there is no correlation, that the bladder mesh is "the gold standard". But I am reading of numerous people who believe that the mesh has caused numerous auto-immune diseases. I would really like to get the mesh removed.

Posted by

on
I got Mesh Implant 2012, pain clinics all they said am not pacing you need see a physiologist.Now am getting made do voluntary work as DWP wouldn't except anything of the Mesh Implant report i had at the Tribunal said am fit for work, yet am crippling with my left foot arch flattened ,walking make my pain worse &backache.3 years ago MRI scan showed hemorrhage cyst left side which same side crippling me my left foot giving me severe pain now today! I have had chronic cough from January never smoked in life.GP said Mesh Implant wouldn't cause the symptoms i have you would be told if it was. I do want a job but not like this making go for Interviews away at Dundee 2 hrs in a bus yet am in pain.Yet my pain is nothing at all to do with the Mesh Implant!!!!!!!!!!!!!!!!!!!

Posted by

on
Hi, I feel u 15 yrs of hell. Each yr declining in activities. I know how u feel. I'm finally getting help. Being told an treated like u are mental is aweful. Dr. Put me on so many meds my lincense were takin after a wreck not my fault. Now fighting for them bk. I quit those meds. Now I suffer to know it was the sling. Herinated bladder an prolasped uterus. I'm mad an anger I have been in an out of hospitals across the east coast for strange infections couldn't explain. Once icu couldn't explain that either. So there we will rise above this somehow. But FDA, an all should be held accountable. Its American greed. No better than Berne Madoff. I don't trust anything no more. This is civil an criminal.

Posted by

on
I went to my Urogyneclogist may 21 2015 for pain and cramping in my pelvic area I'm also showing signs of blood in my urine for over a month now I haven't been able to stand for more than 10 minutes at a time I am unable to walk any where without my legs and toes hurting my legs are also hurting when I sit down my toes are either numb or tingling all the time my arms feel weak I'm having problems breathing my Dr looked at me and told me my mesh's were holding up pretty good and then tells me he would be back into talk to me in a minute when he comes back in he said that he thinks I might have interstitial cystitis and he schueld me for a Hydrodistention of the Blatter could all of my systoms be coming from my pelvic mesh sling and my prolĂ sph mesh and can I add these new systoms to my mesh law suite Thank You

Posted by

on
I had a mesh implanted for pop in 2006. Now, 2015, disabled since 2009 from inflammatory arthritis. My sacrum, left hip, both SI joints hurt constantly. Had several nerve blocks done both sides, only partially helps. Also constant pain in right lower quadrant, mimics appendicitis. Migraines, extreme fatique, fibromyalgia. I have no life. I cant do anything. Exact opposite of what I used to be. On pain management since 2009, my life equals morphine around the clock, prednisone or feel like I have rigormortis, Zoloft which has probably kept me somewhat sane, and ambien so I can sleep. No sex for years, too painful. I try to walk my dogs every day, that lasts 10 minutes if they are lucky. ok what can I do???I feel like I am slowly dying, I need help.

Posted by

on
I had two supposed Biologic mesh implants in 2004 and now can't stand or sit for any length of time. Was a nurse and now I am disabled.

I have severe pain on my right side, severe pain in my back which radiates down my right leg. I have no energy. If stand or walk for an hour the pain becomes very severe.

Even urinating and passing stool can become excruciating. I also have very painful bladder and rectal spasms.

Doctors say it can't happen with the Biologic mesh, Pelvicol and Repliform. Then why did it start after the implants and continue to get worse.

I have a lawsuit going.

Trying to get a doctor to believe you is hard also.

People need to know about this. My life, as I knew it, stopped. Can't work from the pain and no intimacy because of the severe pain. No more exercising. I am basically homebound now. I live alone with this terrible adverse reaction that they say is not possible. Anyone else with problems from the biologic mesh?

What is going on?

Posted by

on
I had two supposed Biologic mesh implants in 2004 and now can't stand or sit for any length of time. Was a nurse and now I am disabled.

I have severe pain on my right side, severe pain in my back which radiates down my right leg. I have no energy. If stand or walk for an hour the pain becomes very severe.

Even urinating and passing stool can become excruciating

Posted by

on
I got a transvaginal mesh when I had prolapsed uterus in 2002. I've had lots and lots of vaginal infections. Now I'm going though lots and lots of pain in my legs and arms . Have had lots of blood test done. ANA is positive and other test came back not normal. Could all this be because of the mesh?

Posted by

on
I had a hysterectomy in november2010 in June 2011 I had surgery again for scar tissue removal. The surgeon put a mesh on my cervix to hopefully keep scar tissue from forming. I am now in so much pain. My cervix hurts so bad. At dr today nurse concerned once she heard I had a mesh. I am wondering if I have the bad mesh. Intercourse is painful. Sitting hurts I have been getting infections,bacterial. I am going to find out what kind of mesh was used. I am going to have to go to specialist for surgery to see about removing scar tissue and why my cervix hurts. I was examined and cervix looks good but it is tender and very bothersome. Has anyone had a mesh placed on cervix like me??? I am confused,scared and in pain!!!

Posted by

on
I had my original surgery for a bladder sling 3/11, 6 months later I started with serious pain in my right groin that shot halfway down my thigh. Sex was/is painful. I've been to all kinds of doctors and they sent me to a pain management doc, I'm sure just to stop me from being such a pain! After more complaining, they sent me for an MRI which showed that I had a torn labrum, which is now repaired, however, I STILL experience daily pain. My question is, when did they stop using the "bad" mesh and how do I find out? I now have an appt. to go back to my urologist, which I'm sure they're going to say "it's not the mesh."

Posted by

on
Hi ladies, in response to what's is wrong with u, if u feel it is the sling, I carnt stress for u to find a surgeon urgently and have it removed. It can be done. I had what they call a rare case. Diagnosed with IC, hospitalised constantly from infection after infection in my bladder, even all my lymph nodes swelled up in my pelvis, and was hospitalised because it was causing pain. Then I got bad pelvic pain24/7 pain down my thighs, in my groin, then eventually I couldn't walk properly. Groin and thigh pain was from my muscles constantly being in spams due to inflammation. Pelvic pain caused by inflammation. And IC was caused by the toxin in the mesh causing an autoimmune response to the area. I found a surgeon to diagnose me, as my specialist wouldn't remove it. Even after asking him twice. Now that I have had it removed I can finally have sex without an infection in my bladder comming on. The pain down there has gone. And now that I think back after having my mesh implanted I Rembrandt having bad sinus attacks for twelve months after. If u have had mesh implanted and u develop other symptoms after anywhere in the pelic area. It is the mesh!!! For IC if u developed this after the mesh implant, it is the cause, if u have the mesh removed and u need something else to help settle the IC u can now get steroid injections into the bladder wall. I had that whilst i still had the mesh in as specialist was misdiagnosing me but my inflammation ended up so bad I couldn't walk and my gp sent me over 3000 Klm to see a surgeon who could remove it. Best thing I ever done. Everyone's body is different, I cannot stress enough that if u suffer symptoms in the pelic area or the thighs, bladder, uretha. After a implant your body does not agree with the implant and needs to be removed. All the best I hope this helps.

Posted by

on
My mother has been suffering from what appears to be an autoimmune disorder and we believe her bladder sling may be the source of the problem. Does anyone have research to share on this topic? Also, any doctors you recommend you are open minded enough to consider that synthetic sling material may cause health problems? Thanks.

Posted by

on
I had a TVT device 810041B inserted in 2004 & I have battled bad health ever since. After listening to my specialist sing the praises of MESH TAPE almost mocking me, I was given an
internal examination which found I was right after all. Suddenly her attitude changed and she now wants to cut out some of the tape. She said it wad a simple procedure but I reminded her that I now suffer with CRPS. I feel this too resulted from the operation, as, from what I have read, it is prevalent with people with Fibromyalgia. I feel like there is no answers for my situation and my life is ruined. I struggle not to go into depression and feel totally isolated.

Posted by

on
I can relate with you you mine was put in place in 2008 one month after first recall when I had a complete hysterectomy and chose also not to "pee" everytime also. I've been fighting this for four years now. Can't go back to work. I have not been diagnosed yet with an autoimmune disorder but know something wierd is going on. I have infection after infection, inflammation no one wants to research, and no one wants to discuss..I too can not have sex with my husband and it is horrible. Be persistant and be your own advocate because I was told (after being dismissed the moment I mentioned mesh) from many doctors. One of them was honest enough to say that "they do not know how to treat the symptoms or know what to expect in future outcome". They don't know how to treat us, but quick to get rid of you. So in the meantime be prepared for shutdowns, being told its in your head. They say there is no proof the symptoms I continue to get are related. I have all listed by FDA. I've told them no proof it is not...what a coinsidence. Contact your hospital and obtain the sticker page from the implant. Get all your records if you can, you would be surprised what they say about you. Maybe you might not want to but have your attorney handle. They need support groups for this, I feel so alone up against these doctors.

Posted by

on
I had my TVT on 3/21/03. I am still being treated for infections and have been diagnosed with I.C. now which I believe is all due to this thing. The doctors just say "you don't have a recalled mesh, you have trans vaginal tape. Tape doesn't cause any problems unless it's too tight". I have my op notes & implant log & it doesn't even identify the TVT brand, so if there is more than one I'll never know. I can't even have sex anymore and my husband and I just had our 40th anniversary in February. I am very angry. All I wanted was to not pee every time laughed & not wear pads all the time. Now I rarely even leave my house. I.C. is a very painful disease and it has wrecked my chance at a normal life. I'm going to see the doctor again next month to get rechecked. I am on medication daily.

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