Pelvic Surgeon Dr. M. Tom Margolis on ‘Getting the Mesh Out’
Aug 26th, 2011 | By Jane Akre | Category: Feature, Medical News
Dr. M. Tom Margolis, Bay Area Pelvic Surgery
As a Pelvic Surgeon/Urogynecologist, Dr. Margolis helps women suffering from incontinence, pelvic organ prolapse and a variety of surgical problems involving the female pelvis. He has done mesh removal surgery from his office, Bay Area Pelvic Surgery, in the San Francisco Bay area. (Office website here).
On July 13, 2011 the FDA published its second and much stronger public warning regarding the use of transvaginal synthetic mesh for pelvic organ prolapse.
Dr. M. Tom Margolis - Pelvic surgeon/Urogynecologist, Bay Area Pelvic Surgery, says he applauds the FDA actions because he has always held the strong position that transvaginal placement of synthetic mesh of all types for prolapse and stress incontinence was dangerous and could lead to surgical mesh complications. After helping scores of women suffering from side effects of implantable mesh, Dr. Margolis talked to MDND about his experience with placing and removing synthetic surgical mesh.
MDND: A woman is told by her doctor she has pelvic organ prolapse or stress urinary incontinence, what questions should she ask?
TM: “If she is seeking surgical treatment she should ask – How many surgeries do you do a year? Do you know how to do anything other than mesh surgery? Surgery should be the last choice and only for those who have tried nonsurgical treatments and failed or for those who don’t want to consider anything other than surgery.”
MDND: What are nonsurgical treatments?
TM: “Here I am suggesting nonsurgical options and surgery is my livelihood. But it should be considered the last option. Try exercise, kegel exercises or a vaginal pessary. They should go to the web and read extensively. If you don’t study it well, you will not hear all of the different opinions. There are lots of people who are adamantly pro mesh. If you only go to their websites you will get the opinion mesh is the only thing. Either don’t study it or study it very well. Understand for everyone who is pro mesh there are a lot who really are opposed to it.”
MDND: Having interviewed a lot of people who have been sold on mesh they are told the same things – “It’s the gold standard”, “You’ll love it”, “It will fix you right up”, “Everyone is using it”. What should a woman or a man with a hernia (which uses synthetic mesh for repair) do if they hear these words?
TM: “Tell them to leave the office immediately. It is not the gold standard they are not going to love it. You are talking to a surgeon who has taken this (TVT Mesh) out more than 104 patients many of them numerous times trying to get this shxx out, and I’m just one guy. There is no reason to beat around the bush.”
MDND: Do you feel sutures alone are superior. How about biologic mesh?
TM: “Depending on what different areas have prolapsed. They can be repaired with sutures and biologics and sometimes synthetic materials that are not placed transvaginally. An abdominal or laparoscopic approach is where there is no vaginal incision and a synthetic may be used safety, but it should never be used when placed transvaginally. Organic mesh (biologic) can be placed vaginally but synthetic should never be placed vaginally. It’s pure biology. When surgery is done transvaginally, that is working through the vagina, that surgery is defined as “clean contaminated”.
“There are four states of cleanliness in terms of surgical fielding = clean/ clean contaminated/ contaminated/ grossly contaminated. Vaginal surgery is by definition “clean contaminated”. It is a cardinal surgical rule that you may not place an implant, a synthetic material, through any form of a contaminated field without significant risk, infection, mesh breakdown and failure. When surgery is done in a clean field, that is abdominally, you may place mesh safely.
“I’ve done thinking close to 1,000 laparoscopic procedures with synthetics and I’ve had maybe two infections. It’s not impossible but in transvaginal surgery you can never sterilize the vagina, it’s always a contaminated field.”
MDND: But what about men who have also had complications with synthetic mesh, eroding, migrating?
TM: “For a hernia, I don’t know. Any foreign body implanted into human beings can be infected and cause horrible complications, like the prosthesis heart valve, that’s why orthopedic surgeons wear space suits, they are so concerned about contamination.”
MDND: What kind of complications have you seen in patients?
TM: “Immediate operative injuries and delayed post-operative injuries such as bleeding injuries to the bladder and bowel, then there is mesh infection and erosion. It’s really not an erosion, it’s a wound breakdown from an infected mesh. Erosion is sort of a watered down phrase the pro mesh people are using. The mesh gets infected the wound breaks down the mesh becomes exposed in the vagina. This process will cause pain, scarring, painful intercourse for the woman and man. The mesh will cause further contraction scarring and closing of the vagina, bleeding urethral obstruction, erosion into the bladder and bowel which I’ve seen.
MDND: With the aging of baby boomers will see more of this?
TM: “Tons of it. Horribly. Mesh has been good for my business because I take it out and it usually involves more than one surgery, but I don’t want this, this is bad. It’s all about the Hippocratic Oath – First Do No Harm.”
MDND: Have the surgical precut kits contributed to the problem?
TM: “This all started with the TVT in ‘96 which was based on the Olmstead study. The original mesh was problematic enough but it wasn’t anything compared to the mesh kits, TVT kits are ten times as bad. They were their own death knell. They were so big and problematic. They got the attention of the FDA. They took a bad idea an exploded it.”
MDND: How are doctors trained in using the mesh kits?
TM: “They fly them to New Orleans and stick them in a cadaver lab. It’s a weekend course given to a general gynecologist who does two or three surgeries a year. Fly them off to a weekend of wining and dining and a couple of cadavers then fly home and have the reps push them.”
Editor Note* Margolis says mesh kits are all transvaginally placed mesh or TVT systems.*
MDND: How do you feel about the 510(k) approval (for marketing)?
TM: “Every synthetic mesh should go through separate approval. If they did one, it would never get approved. Look at the study from Stanford, a randomized study published in Obstetrics and Gynecology in August 2010.
See the study here:
“In the study, they aborted it after three months because there was a 15.6 percent vaginal mesh erosion rate with no difference in overall cure rates. The complications were greater than what the ethics would allow. This came from some of the mesh proponents.
“There were 32 with mesh and 33 without mesh. An analysis of the two groups found no difference with recurrence, and five women experienced vaginal mesh erosions. The bulge of patients was cured in 93.3% of the mesh patients and 100% of the no-mesh patients. As a result, the study concludes with a question about the value of adding synthetic polypropylene mesh for the repair of vaginal prolapse.
“I think there are some devices that are similar enough it’s okay to piggy back or grandfather them in based on prior work, however, the sling and mesh manufacturers have abused with extreme prejudice the 510k process. With the ProteGen mesh, the FDA should police itself. If they take it off the market, the FDA should revisit all other devices that were approved based on that.
“The 510 (k) process is a reasonable one but you can’t just assume something is okay than have everyone jump on the bandwagon. It has to be monitored.”
MDND: Does that include synthetic mesh?
TM: “Transvaginal synthetic mesh should be pulled off the market. Anything that is designed to be placed transvaginally that is synthetic should be pulled off the market because transvaginal surgery is contaminated.
“I care for women who have been butchered by TVT synthetic mesh. They no longer have functional vaginas. Say a 35-year-old woman wants a little surgery to have a better quality of life after having two children only to end up with a nonfunctional vagina that will never be functional. Sexual relations are a good thing, a nice option. Even without sex it’s nice not to have pain and bleeding.”
MDND: Can you ever get the mesh out?
TM: “Maybe in the 50 percent range you can get all of it at least half of the time. It depends on the mesh kits used. The big ones? Forget it no way. They are impossible and I’m pretty good at getting those things out. Trying to get mesh out of the vagina is like taking rebar out of a sidewalk and leaving the sidewalk intact – good luck! #
Background on Dr. Margolis from his website:
“Dr. Margolis earned his MD at the University of Kansas where he also completed his Obstetrics and Gynecology residency. He then completed The Pelvic Surgery fellowship at Emory University in Atlanta, Ga. where he held a faculty position as instructor. He subsequently held full time faculty positions at Northwestern University and Stanford University where he served as Chief of the Division of Gynecology and founder/director of the Center for Pelvic Surgery/Urogynecology. He founded and directed the Center for Pelvic Surgery/Urogynecology at the Women’s Cancer Center of Northern California. He holds an Associate Clinical Professorship at the University of Wisconsin where he practiced for two years before moving back to the Bay Area of Northern California in 2009. He is also Adjunct Clinical Assistant Professor at Stanford University. He is an active mission surgeon traveling to South America and Africa on humanitarian surgical missions.
“Dr. Margolis applauds the FDA actions because he has always held the strong position that transvaginal placement of synthetic mesh of all types for prolapse and stress incontinence was dangerous and could lead to surgical mesh complications. His position is based on core biologic principles of wound infection in contaminated fields (well known principles established in the surgical literature decades ago), his own review of the FDA MAUDE database which has reported mesh complications for almost a decade, numerous reports in the literature of major complications with mesh and his own personal experience removing mesh in scores of patients.”
Bay Area Pelvic Surgery Website here
What diagnostic tools/tests can detect migration and/or erosion of the mesh? Can Dr. Margolis recommend a pelvic surgeon in the Cincinnati, Ohio region that is qualified to remove vaginal mesh from patients? I had the Ethicon/J & J TVT mesh sling implanted in 2008 and have constant pain in my groin/bladder area and lower intestine. My family Dr. ordered an MRI but that did not show anything of concern. The urologist that implanted the mesh ordered a cystoscopy but I have not had it done because the cost would be from my high insurance deductible. If the mesh has not become embedded into my bladder, I’m not sure what the cystoscopy will show. I don’t know what to do next, but I do know that I do not want to have this abdominal pain the rest of my life! A law firm told me I cannot file a lawsuit unless the mesh has “eroded.”
Beverly- Dr Shlomo Raz at UCLA has an ultrasound that can see the mesh. From my understanding an MRI will not detect it and neither can an X-ray. Its called the vaginal ultrasound machine. I can’t imagine he is the only one who has this capability. I will check with Dr. Margolis and get his opinion… Will get back here..Anyone know of a doc in Ohio with experience removing mesh? Thanks-jane a.
Dr Margolis says in Ohio he recommends:
” Mickey Karram is the guy. He is excellent. Here’s a link for her, ( meaning you Beverly)
http://www.thechristhospital.com/Urogynecology/
Hope this helps,
Tom Margolis, M.D.
650-228-4052
bapelvicsurgery.com
Beverly- Full Disclosure – You should know that Dr. Karram receives research support from Ethicon Women’s Health and Urology and is a consultant and speaker for Ethicon Women’s Health and Urology. Some people say they want to take that into consideration when choosing a doctor to remove surgical mesh.
Additionally Dr. Karram’s outreach to women in the form of the Foundation for Female Health Awareness (nonprofit) and Women’s Health Experience is clearly funded by the following sponsors:
http://www.womenshealthexperience.com/meetSponsors.asp
I saw your post on Topix and wanted to let you know that I live in Ohio and have made several trips for removal of mesh to Dr. Phillipe Zimmern in Dallas, TX. One of the most caring physicians I have ever met…extremely knowledgable and talented.
Thanks for getting this info out there…this mesh is horrible! No one can imagine or understand unless you have been through it.
Debbie W.
Debbie W.- Someone has asked me to find your email so she can have a discussion with you about Dr. Z. and what you had done. She is legit and I vouch for her. She is not associated with a law firm or anything….She is an injured patient who lives in Texas and Dr. Z is the closest to her. She has really taken a leadership role in helping others so I would like to help her. I note you did not leave your email, Please feel free to contact me directly at jeakre@gmail.com if you don’t mind. Thank you!! Jane A.
Debbie, I was reading your comment about the mesh & the doctor you seen in TX that takes them out. I have a good friend who has the same issue as you with the mesh inside of her. She & her husband took a 12 hour trip to Dallas Tx to see this doctor about 2 mos ago in hopes of getting the mesh removed. THe doctor said it was one of the worse cases he had ever seen & wouldn’t do the surguy until the infection in her was cleared up. If you cut into her she could die. But we have not found anything that will make the infection go away, & my friend is going to call the doctor again & beg him to remove it. She will die with it inside of her. I didn’t know what your personal experienc was with this same matter but if you know anything we don’t can you please share what you have experienced. THanks Misty Henderson. My email is mhkelly_1@yahoo.com
Thank-you for taking the time to address my comments, Jane & Dr. Margolis. I am printing out this webpage and several articles about the mesh problems for my GP. She ordered the MRI and referred me back to the Urologist (Dr. Buffington in Cincinnati) who in turn advised me to get a cystoccopy to see if the sling had eroded into the bladder. The “tugging” I feel in my lower intestines and pain in my bladder area that permeates into my lower back, all tell me I need to see just where the mesh is inside my body. I am no doctor, but I hate to spend $1,500 on a cystocopy when it may not tell all I need to know. I will ask my GP about the sonogram. I had a complete hysterectomy in 1997, perhaps a mistake as perhaps it was then prolapse began which was the beginning of a downhill road…
Dr Margolis, I just want to thank you for speaking out so candidly and truthfully about transvaginal mesh surgeries, both here and at the FDA’s meeting this past Sept. You flew out at the last minute to speak for the literally FIVE MINUTES that you were allowed. Along with the injured patients- five minutes each. Thousands of injured women appreciate your honesty and boldness. Thank you for your surgical skills and for trying to help women out of the horrible, and many times, aboslutely unbearable, situation they unexpectedly, and often suddenly, found themselves in. Again, thank you!
Dr Margolis, I am wondering how much research has been done with severe foreign body reaction relating to transvaginal mesh. I had a hysterectomy Febuary 2009 & transvaginal mesh placed for urinary incontinence. Three weeks later I started breaking out in red raised itchy rash, blisters, and swelling that spread all over my body. My lower legs were the worse affected. Dermatology called it lichen planus. This was complicated by a MRSA infection. 2010 I had a motorcycle accident. Skin trauma caused a repeat outbreak of MRSA. September 2011 was my second outbreak of the same itchy rash that occurred after the mesh placed. This time my forarms were affected. I have skin discolarations/scarring from both outbreaks. It is almost resolved now with no MRSA outbreak. Other problems that I battle with is a very sensitive gut that seems to be getting worse. I cannot eat wheat/gluten since it feels like a rock in my stomach. Dairy sits like a rock and blows out like a rocket at the other end. Tomatoes make my gut very painful. Soy upsets my stomach. There are some more but these are the main ones. None food/gut problems were an issue prior to the mesh being placed. Currently I am having prolems with diarrhea, cramps,some stomach pain. My guess that there is another food that I need to delete from my diet. My skin is very sensitive. I need to wear 100% cotton clothes. I can tolerate a little bit of spandex mixed with the cotton. Healing time for minor abrasions is double what it was prior to mesh.
Hi,
My name is Shirle and I just seen your story and would love to speak with you because I also have a skin condition very similar to yours. Please contact me sjryan157@yahoo.com or 713-305-5127.
God Speed
Shirley
What about mesh used in a hysterectomy?
Hi Paula- There could be various kinds of mesh used in a hysterectomy. They are made out of polypropylene, that is plastic, which some feel causes the problems. You would need to know what type of mesh was used, the model, make, lot number etc. That will tell you more then just knowing what it was used to treat.
I can send you in a better direction with more information…. thank you!
would like to know if you know a physician here in San Antonio, Texas that you would recomend to repair
a rectal vaginal fistula….
I had an implant since 3/2010 and I am in pain 7-days a week and I have tried to address this situation that
I have develope since my pelvic implants whom can I speak to
Do you have anyone you could recommend in the Milwaukee/Chicago area? I went to Dr. Dennis Miller, a urogynecologist, who did a partial removal and 12 months later more is eroding with worse pain and tissue loss where first bit was removed. He’s a spokesman for Ethicon, too
Thank you for any help you’re able to provide.
YES! I had two gynecare meshes installed, both a bladder sling and full prolift repair. Caused numerous problems and were removed by an excellent surgeon at Froedert Memorial Hospital/Medical College of Wisconsin.
She is a top urogynecologist and did a great job. It was not possible to remove all the mesh, but there were no major post surgical complications and I highly recommend seeing her.
Her name is Dr. Julianne Newcomer.
I had a full hysterectomy and monarc urethra sling done Aug 2, 2011, have had horrible pain and complications ever since, been passed from Doctor, to doctor, to theraphy, to another doctor, finally I pulled my own records to see how my body has been through all of this, not good, I found out MY bladder is having problems, possible kidneys, and have lived with unbareable pain seems like for ever, I want this out and I would like to know who is the best in Portland, Or, I am now seeing Dr Rockove and he seems pretty good, from what I have read, I want this out all at once, don’t want tons of surgeries, to add more to the scare tissue I have now, I heard It’s like taking rebar out of cement and trying not to break the cement. GOD help Me.
Please please respond,
Thank you, and I send out all my prayers out to everyone that is having this problems and just getting pushed aside.
Hi Kim-
I’m so sorry you are having this pain.
You may want to visit Kathleen’s suggestions on talking to your doctor. I’m glad you feel confident with your present doctor. Is he or she aware of the FDA’s 2 warnings, one in October 2008 and the other in July 2011? some people feel a partial removal complicates things further .. Thoughts anyone?
As the husband of a woman who has had several partial removals. My personal opinion is all has to come out! Partial removals from what I have researched only leads to more problems more scare tissue and more surgeries. The sad thing is there are very few doctors doing entire removals. This site has tons of information that is very vital for you to read. You can read about us here or on http://www.tvtno.org which has many stories about us as we are currently establishing a nonprofit organization to help women suffering from this horrific nightmare. We are working closely with everyone we can to find the facts they need to deal with these horrible slings. This is a crime and many should be prosecuted for allowing it to continue. Even Jeffery Shuren of the FDA recently admitted that these bladder slings are a problem but yet Tuesday when the holiday is over more innocent women will be raped of their lives by trusting they are making a good choice not knowing the truth!
Kim,
When I said this site I mean HERE where your at Jane has compiled the best collection of information and truth about this mesh and without her we would all be so lost!
Do you know of a doctor in Houston Texas? I had a complete hysterectomy, tvt sling, and colon repair in 2003 ( the original uterine resuspension failed the year before- sadly after many opinions and 2 years before I had tried exercises, and pessary to no avail). Currently I am 40. I am experiencing recurring pelvic infections (bladder and vaginal). I have also had some difficulty completely voiding. I have had a cystoscopy with no noted erosion. I feel great as long as I am on antibiotics but 2 weeks later I feel feverish (though no noted temperature), sweats (not hotflashes because I don’t get them when I am on antibiotics), fatigue, difficulty thinking. To say I am afraid is an understatement.
Is there a doctor
in Michigan that can do a full removal of the Monarch Bladder Sling?
I had a bladder sling put in dec21,2012, two weeks postop I began to burn, a searing burning pain, and it never let’s up, my urologist has told me to wait it out.that I can’t be in pain from the sling .that its fibromyalgia, today he said it was just a coincidence that the pain started after the sling, gave me pain pills and antidepressants.. Am I crazy? I need to go for a second opinion.. I saw that there is a doctor in Dallas that does removal..that’s three hours from where I am, but worth the drive
There is a Dr. in Frisco Tx. just north of Dallas. Her name is Aimee Nyguen. She is a uro/gyn who will be very helpful in determining what to do about your mesh. She was willing to remove all the mesh for me, but advised against it as recommended partial removal and had surgery to loosen the mesh in the pelvic floor. Said we can always remove it all but should be conservative and try to reduce pain without full removal as all would prolapse again probably. She is wonderful and can be found on google for her website. God Bless and my prayers are with you!
Hi. I am so hopeful and praying that you may be able to help me. I am , and have been struggling for years with awful chronic pain. First started with endo 20 years ago. After multiple surgeries(lap) to laser treat, a couple of children and a few miscarriages, I resulted in a hys in 2006. At this time my doc removed one ovary, tubes, and uterus. She also did a bladder repair using Boston scientific mesh. I have struggled since day one with pain, resulting in a second surgery exactly 1 year to remove my second ovary. This solved only some of the pain. I went a few years just dealing with it thinking I had nothing else to remove. Then in 2011 another doc said it had to be my cervix. Had that removed with major complications. Then after another of complete suffering(worse than ever before) I started seeing a new doc to assist me. I have been thru multiple (7-9) trigger point injections both abdominally and vaginally(at the cervical cuff-excruitiating) monthly. After 11 months of this treatment along with physical therapy, we(my doc and I) decided that surgery was the next option to try to repair what was done by my last surgeon. This was done almost 3 months ago, and the pain is is not solved, in fact more severe than ever. I know that they have to dissect my bladder when doing the vaginal cuff repair or the removal, so I have wondered if that is part of the problem?! I still am unable to do much and can’t return to work still. None of my docs have ever mentioned that my problem could be the mesh!? I have just settled in the fact that this is my life sentence, and it is not fair. My relationships with my husband and children are suffering after years of constant horrific pain. Please help if you can with your thoughts. I do not live anywhere near you, so would love to hear from you on any references in UTAH for a urogyno with expertise and hopefully the equipment to help get my life back.
Bev
I live in the Philidelphia area and would appreciate some names of doctors in my area or on this coast that are Urogynecologists that are experts in removing vaginal mesh. Thank you in advance for any info you can give me.
Nancy, and Dr. Margolis
I live 50 minutes outside of Phila in NJ. If you happened to know of or Nancy, if you have found a Dr, that specializes in removal in this area – would you please share the name with me. Thank you Sharon
Does anyone know of a Doctor in Northwest Indiana or Chicago, IL. area that does mesh removal and repairs. I had a TVT Sling with mesh done in 2002. I am now having a lot of pain and burning. It feels like razor cuts. Every time I get to active the pain gets so bad that I can’t even walk.
I have had complications from the mesh as well from a 2008 implant posterior and anterios. Last August, I was sent to Cleveland Clinic by my physician in Kansas City. He had removed as much mesh as he could but the right side had migrated to my thigh and attached to organs and he would not attempt that. He recommended Dr. Howard Goldman at the Cleveland Clinic. At one time, Dr. Goldman advocated partial mesh removal, but now advocates complete removal. He did an amazing job . It was a brutal surgery, but successful as far as getting the mesh out. I won’t say that I am back to normal, whatever that is, but my quality of life is greatly improved.
I was also wondering what test really show if the problem is being caused by mesh. I hate to waste time and money on test that won’t show what we need to see. Already had a vaginal ultrasound, it showed nothing. Thank you for your time.
Hello, I have had a boston scientific mesh sling in since 2010 and have had nothing but problems that have gotten worse over the last 6 months, I had a urologist do an exam 2 times and said my mesh was eroding into my vaginal wall, but wouldn’t take it out, stating that he doesn’t do that. My question to Dr. Tom Margolis is; does he know of a doctor in Utah that will attempt to take my mesh out besides Dr. Yvonne Hsu. I was not really impressed with her at all. I am in desperate need of getting it out, I have nausea, severe cramping, my back and buttocks hurt. I have bleeding after intercourse and several other side effects. Please help me and recommend me to someone in Utah. Thank you.
I had a total hysterectomy in July 2011. I was unaware that mesh was used, but have had complications since the surgery including inability to void bladder. I had a foley catheter for 9 weeks post surgery, infections, etc.
The doctor that did the surgery has since retired and I’ve seen another doctor due to pain and spotting. She can see eroding mesh during regular pelvic exam. I have had numerous infections and am still unable to empty my bladder fully, though I am have now added incontinence to my list of issues, not to mention the pain and cramping involved. I’m having urdynamics testing done tomorrow.
I’m in Roanoke, VA but willing to travel anywhere there’s a doctor that knows what they’re doing for mesh removal. I’m going through a divorce now, partially as a result of all of my health issues and when that’s final, I may not have health insurance. I need something done SOON. Does anyone know of a good surgeon?? Please help me. I can be reached at carmella225@gmail.com.
Carmella –
My story is on this website here: http://meshmedicaldevicenewsdesk.com/patient-profiles/deb-c-suffering-stress-incontinence-mesh-injuring-women-too. I went to Dr. Raz at UCLA for mesh removal. Many people believe he is “the master” at removing mesh, and pelvic NON-mesh repairs. I traveled all the way from NY to go to him because I could not find a doctor in my area to remove my sling entirely. I heard of a couple others out of my area, but figured if I had to travel, I might as well go to the best. He was well worth the effort to get to, and I would (and do) recommend him to anyone. The other docs at UCLA are also becoming very well known. Here’s a link with more info on them: http://teapapers.com/bladdersling/2012/08/so-much-hope-for-mesh-removal-surgery/