MND Editor, Jane Akre
Mesh News Desk readers frequently share what they've been told during the consultation process with a doctor who is encouraging them to have a mesh implant as a treatment for incontinence or prolapse. Unfortunately the stories have not changed much since this story first ran in April. If you have been diagnosed with incontinence or prolapse and bring your concerns about polypropylene mesh to your doctor's attention, the following are some of the responses you may hear. Any patient should ask first and foremost, "Is the implant made out of polypropylene?"
True informed consent would provide all of the information on mesh complications including an admission that no one really knows what happens when polypropylene mesh is implanted after many years because there were no clinical trials. Please feel free to share your stories of the mesh sell. Here are some of the things women are still told today by their doctors:
Myth #1 - "Don’t worry- It’s lawyer generated hype."
Love this one. See this link from the Cleveland Clinic as an example.
In this June 2013 post, the Cleveland Clinic tells “The Truth About Vaginal Mesh” blaming sensational news coverage and ads by law firms for spreading fear among women about vaginal mesh. Not leaving it there, the CC also blames the “inexperience of many physicians” using vaginal meshes. (Note CC also makes reference to “Early meshes were not well designed for acceptance into the body" even though early meshes were polypropylene too.)
Fact: The implication is the “highly skilled” surgeons at Cleveland Clinic are your best choice. Never mind that Dr. Goldman years ago proposed partial removals which experienced physicians agree do not relieve pain. See an interview with Dr. Goldman from April 2012 here. And never mind that there are 100,000 lawsuits filed in courts around the globe. That’s a lot of hype by attorneys, not to mention a lot of unskilled surgeons.
Another ad by Mount Sinai here.
Fact: Please note neither ad mentions that the FDA in 2011 said complications are “Not rare" reversing itself on its 2008 public health alert. How is that fully informed consent?
Myth #2 - "That mesh is off the market/ recalled."
Fact: Few meshes have been recalled and almost all pelvic meshes, whether for stress urinary incontinence, or prolapse (as well as hernia repair) are made from polypropylene, aka Prolene, which may ultimately prove to be the problem since is the consistent element of complications, no matter how the mesh is used. Fact: Most mesh remains on the market.
There were two notable recalls.
Boston Scientific’s ProteGen Sling that was recalled by its own manufacturer in a letter to the FDA on January 22, 1999. The reason stated in the FDA’s March 17, 1999 Enforcement Report was “Use of the ProteGen in female urinary incontinence is associated with a higher than expected rate of vaginal erosion and dehiscence, and does not appear to function as intended.” The FDA had received many adverse event reports like this one.
In other words, it was defective. Despite that designation, the ProteGen remains the “grandmother” mesh that has been named as the “predicate” for at least 60 other meshes that have been marketed after it.
ObTape by Mentor was removed from the market in 2006 after the company received reports like this one. Note that the manufacturer gets to decide if the death, in this case, was related to the mesh. Mentor says it was not.
In June 2012 many of the mesh kits were voluntarily removed by the manufacturers, purportedly because they were no longer "financially viable." C.R. Bard took its Avaulta mesh off the market around the same time. it too was relieved of the burden of conducting post-approval studies.
Gynecare, Prolift (J&J)
Removed by Ethicon were Gynecare Prolift Kit, Gynecare Prolift +M kit, Gynecare TVT Secur, Gynecare Prosima Pelvic Floor Repair System Kit.
Suzanne M did an excellent review of how meshes make it to market here.
Fact: The FDA has required mesh makers to conduct post-approval surveillance of their mesh products to see how many women were experiencing complications. Instead of complying with the mandate, the makers simply took them off the market and in doing so, relieved themselves of that FDA order. The FDA required no further follow-up despite the fact that the mesh remains in the pelvis' of many suffering women. DrugWatch did a good review of recalled meshes here.
Myth #3 - "We don’t use that mesh in this country."
Mesh News Desk has heard this one time and time again from Canadian women and that the mesh problem was a U.S. problem, not Canadian.
Fact: Surgical mesh is made by major medical device companies, not Bob's Mesh. U.S. manufacturers, and there are now seven of them involved in litigation, export their products globally. Even though the Prolift is not sold in this country, you can still buy it on eBay. Ethicon has identified exports as a renewed market for medical devices. For a glance at the names of mesh makers, look at the FDA’s order issued January 2012 for them all to conduct post approval monitoring. (522 studies)
FDA January 2012- 522 studies ordered here
MDND- Mesh Makers Who Received 522 orders
Myth #4 - "It’s a “Tape” or a “Sling” not mesh."
This one came to light recently by a woman who contact MND with a pitch she received from a doctor. She was told it wasn’t mesh it was “tape.”
TVT-O from TVT Meshed Up Mesh, UK
Fact: “Tape” is another word for transvaginal tape (TVT and TVT-O) and it is transvaginal mesh! This appears to be intentional confusion. A bladder “tack” or suspension surgery is another confusing term. Traditionally, incontinence surgery involved tacking up the urethra using sutures and was the standard of care before transvaginal mesh. This group is intentionally confusing the issue and in doing so is not providing its patients true informed consent. Shame on them. See here.
The Mayo Clinic here is more clear though it does call these “low-risk” surgical alternatives. The FDA has said that surgery using mesh results in complications that are “not rare.”
Myth #5- "We can take it out if there's a problem."
Don’t worry, if there is a complication we can take the tape out has been heard by many MND readers. This is a dangerous myth and is not true informed consent.
Fact: Mesh is intended to be a permanent medical device implant. It incorporates with the body eventually and removing the mesh that has integrated with the body is likened to removing gum from hair or reinforcing bar from cement. Only a few of the more experienced surgeons in the would can attempt this and most will say at most they can remove 95 percent. This dangerous myth is given to assure women their choice is reversible. Unfortunately after women are told to “give it another 6 months” after experiencing complications, they not only experience more pain but the mesh continues to integrate with the body. Pain indicates mesh should be removed according to expert surgeons.
Myth #6 - "Mesh is FDA approved."
Fact: Not really. It’s is approved for sale, not for safety. It might be hard to believe but the U.S. Food and Drug Administration only classifies pelvic mesh surgical mesh as a Class II moderate risk device, even though it is a permanent implant. It does not require clinical trials (human testing) which would most likely have shown the complications such as mesh erosion, infection, mesh shrinkage, nerve entrapment, etc. That is the FDA’s own 510(k) approval process that allows manufacturers to take the “least burdensome” route to approval. Nevermind that the “burden” then rests on the poor patient who discoverers after the fact that their device received no assurances for safety except from the manufacturer who has the most to gain by its marketing.
Myth #7 – "Mesh Complications are rare."
Fact: While that was what the FDA first said in 2008, what followed was a five-fold increase in the reporting of mesh-related complications. By July 2011, the FDA reversed itself in July 2011 and said in its advisory that mesh complications are “not rare.” See it here:
“The FDA is issuing this update to inform you that serious complications associated with surgical mesh for transvaginal repair of POP are not rare. This is a change from what the FDA previously reported on Oct. 20, 2008. Furthermore, it is not clear that transvaginal POP repair with mesh is more effective than traditional non-mesh repair in all patients with POP and it may expose patients to greater risk. This Safety Communication provides updated recommendations for health care providers and patients and updates the FDA’s activities involving surgical mesh for the transvaginal repair of POP.
The FDA continues to evaluate the effects of using surgical mesh to repair SUI and will communicate these findings at a later date.”
Fact: (Still waiting for that later date) hernia mesh has not received any similar warning, though these pages are full of many reports from those who experience the same symptoms as pelvic mesh patients including pain, erosion, infection, nerve entrapment etc. Full informed consent needs to include the fact of this FDA warning.
Myth #8 – "The Problem is with Pelvic Mesh Not Slings."
Fact: As you see above, the FDA has taken a hands off approach to the issue of slings. That promise to get back at a later date has not materialized. All MND readers need to know, is the polypropylene is the same and has the same qualities of mesh erosion, infection, shrinkage, pain, nerve entrapment. Studies on the effects of polypropylene in human bodies is almost non-existent - Including its oxidative properties, degradation, continuing foreign body response and shrinkage, the treatment with surfactants and cleaning agents, the estrogen mimicking properties of polymers (plastics), the oxidative stress, the lack of biocompatibility tests, the mechanical properties of plastic teeth that wear into tissue. Readers of MND are not making a distinction between pelvic and incontinence mesh, nor have the legal trials on polypropylene mesh so far. The research of Nonie Wideman and her Links on Mesh are notable here.
And her Links to Medical Mesh Research is here.
Myth #9 – "It’s bad doctors who had the complications, not the good doctors."
Fact: This defies logic. With 100,000 plus lawsuits filed- are there that many bad doctors? During the Linda Gross v. Ethicon trial in February 2013, Ethicon did note that some of the doctors taking weekend cadaver clinics hosted by Ethicon and Gynecare, a division of Johnson & Johnson, were not catching on as fast as the Top Tier docs. See Linda Gross Trial Day 19 here.
If a product cannot safely be used in the hands of a medical doctor and the company knows this, why would it continue to market the product to them anyway?
Myth #10 – "Mesh has been used for 50 years without problems."
Fact: This statement has been repeated by the defense lawyers for mesh makers at trial. The quantity of mesh is part of the issue. That statement, parroted by many, refers to polypropylene sutures used in hernia repair. They have been around since the 1970s that is true. Heria mesh implants were never tested by the FDA like pelvic mesh and MND hears from many hernia mesh injured patients who are experiencing life-altering complications. Unfortunately, the FDA has not issued any warning about the rate of complications for this same polypropylene mesh.
And Last But Not Least - Okay Myth #11 - "Don’t Read the Internet."
Fact: Mesh News Desk is laughing over this one. If there were true informed consent, Mesh News Desk would not be necessary. Women are desperately trying to find answers their doctors are not providing. The information here is intended to help augment the discussion a woman has with her doctor and is not intended to substitute for medical advice. A truly informed patient, in fact, can help inform her doctor about the myths and misunderstandings surrounding pelvic mesh.
Enjoy these graphics by a valued MND reader! See if you have heard the same.
Doctors say the Darnedest Things