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