SYNTHETIC SURGICAL MESH FATALLY FLAWED:
MUST BE RECALLED
By LANA C. KEETON
© all rights reserved Lana C. Keeton 03/02/2012
This material may not be published, broadcast, rewritten or redistributed.
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IT’S THE DEVICE, NOT THE DOCTOR!
There is a raging debate between and among the FDA, surgeons, the medical device industry, patients and patient advocates. Why the debate? On July 13, 2011 the FDA issued a Safety Communication Update: “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.”
Proclaiming the FDA has no “denominator”, a group of pelvic organ prolapse surgeons issued “Time to Rethink: an Evidence-Based Response” stating their “concerns regarding the message the FDA Safety Communication is sending to our patients, the healthcare community and ‘unfortunately’ to the legal community as well.” These surgeons are clinging to their mesh as though there are no alternatives.
Public Citizen then called for a ban on the marketing of all currently available non-absorbable surgical mesh products specifically designed and labeled for trans-vaginal repair of pelvic organ prolapse (POP), a recall of all surgical mesh products currently available for POP and all proposed future POP products be classified as a class III device only approved through the premarket approval process.
Profit driven entities selling and implanting synthetic surgical mesh, protecting their financial interests, created a straw man argument: “Surgical procedures are more difficult to compare than pharmaceuticals because they are dependent on the judgment and skills of the operator.”
“Time to Rethink” is a moot argument, and under its current regulatory authority, should be completely disregarded by the FDA. The FDA does not regulate the practice of medicine, nor have authority over, doctors or surgeons. The FDA regulates medical devices, not surgical procedure.
Even if the FDA had the authority to regulate the practice of medicine, the POP surgeons have no basis to take the position the FDA’s MAUDE database adverse events reported for POP repair were caused by bad surgeons for the following reasons:
1. Surgical report not available through adverse event reports on MAUDE database.
2. Injured patient not available for examination by the POP surgeons.
3. If the premise were correct and the adverse events are caused by bad surgeons and the average doctor is unable to use mesh/mesh kits per instructions for use provided in the package insert, the mesh and/or mesh kit is defective. It is a flaw in the usability of the design and consequently, a flaw in the medical device itself.
Other professional medical societies recommend educating the patient of the harm, but take no actions to stop the harm. The American Congress of Obstetricians and Gynecologists (ACOG) responded to the FDA’s 2011 warning with its Practice Bulletin #85, “Pelvic Organ Prolapse” (reaffirmed in 2009): “…patients should consent to surgery with an understanding of the postoperative risks and complications and lack of long-term outcomes data.” ACOG’s response to new data in the FDA’s 2011 warning is its’ outdated 2009 Practice Bulletin?
ACOG further states: “Fellows should follow the emerging literature closely to remain knowledgeable about which techniques and products should be avoided and which are ultimately proved to be of benefit to patients.” Exactly when and how are Fellows supposed to know techniques and products have been proved to be of benefit to patients? What guidelines does ACOG offer? This in no way informs the debate. These products and procedures are ever evolving because they cause significant harm and do not provide better outcomes.
Following the October 2008 FDA warning, the American Urogynecologic Society (AUGS) presented a January 2009 webinar pointing out to their members how to avoid legal liability from surgical mesh implantation by informing women of the complications of mesh. Perhaps if they had put down their scalpels then, there would not have been another 2,874 seriously injured women reporting adverse event reports on the MAUDE database and the July 2011 Patient Safety Communication would not have been issued by the FDA.
Still today, patient consumers are not adequately informed of potential prolonged, delayed and irreversible disorders from the implantation of synthetic surgical mesh. Daily thousands of women continue to be put at risk for serious harm, and even death, from synthetic surgical mesh implantation while POP surgeons protect their “important tool in our surgical armamentarium” while professing “This large segment of highly dedicated
surgeons,…could suffer unjustified and arbitrary medical-legal exposure.” POP surgeons have the power not to pick up the scalpel to implant surgical mesh in women, protecting themselves from medical-legal exposure and women from debilitating, life altering permanent complications. There are other options available.
“TENSION-FREE” CONCEPT FLAWED
Surgically implanting mesh without sutures purposely unleashes the body’s natural inflammatory response. The body attempts to encapsulate or reject the implanted foreign body polymer. Acute inflammation is not followed by healing. Chronic inflammation sets in creating a cascade of life threatening inflammatory responses.
Mesh is not tension free once human tissue scars into the interstices of the mesh. Inflammation from scar tissue growing into the interstices creates a scar plate with greater strength than the surrounding tissue. Tension is placed on surrounding muscle, tissues or organs. This process stops normal body function.
In pelvic floor repair, the tissue-mesh scar plate can create more serious problems than the original prolapse. Achieving anatomically correct pelvic floor is virtually impossible as the mesh-tissue scar plate displaces other organs, tissue and muscles, again stopping normal body functions.
Synthetic Surgical Mesh fails to meet the FDA’s 510(k) “Intended Use/Indications Statement” for pelvic organ prolapse repair. It fails to bridge and/or support fascial defects in the vagina because it is incapable of following the direction of the fascia, particularly in the pelvis. It actually stops normal body function because it creates an amorphous matrix. Long term, failure of Synthetic Surgical Mesh is highly probable, no matter who the surgeon, what the surgical procedure, who the manufacturer of the device or where the placement of the mesh in the pelvis.
What is not being debated:
1. Risk Evaluation and Mitigation Strategy for potential irreversible complications.
2. The root cause of the irreversible complications
3. No established protocol for the visualization of the mesh in the body through MRI, CT Scan or Ultrasound.
4. No established mesh removal protocol. What surgical procedure addresses the complications? Are there surgical procedures to address the complications? Do these procedures account for the in vivo shrinking, hardening and/or degradation of synthetic surgical meshes used for hernia repair, bladder suspension and pelvic organ prolapse repair?
5. The “skilled” surgeons blaming the “unskilled” surgeons hypothesis is a straw man argument. Even the “skilled” surgeons are frequently incapable of removing mesh.
6. Hundreds of studies, research papers and abstracts only recite the facts as seen by medical professionals from their individual perspective as doctors, not evaluations of the overall flawed concept of the use of synthetic surgical mesh.
7. There is no comprehensive analysis of the physical and chemical properties of the petroleum based polymers used in the manufacture of synthetic surgical mesh in relation to the human body or how mesh physically and chemically breaks down in the body resulting in life threatening chronic inflammation (which may lead to autoimmune disease).
8. Who, what, where, when and why are missing from the narrative.
Despite the debate, still no clear path exists for patients suffering symptoms of weakened or torn tissue evidenced as hernias, incontinence or pelvic organ prolapse. All the current market conditions which precipitated the FDA’s July 13, 2011 warning of trans-vaginal mesh implantation, are the same today, except there is a national dialogue and huge awareness of the serious complications of synthetic surgical mesh implantation.
There is a tremendous amount of discussion without real solutions. Patient harm continues unabated. Hernias, incontinence and pelvic organ prolapse are not diseases. They are conditions. The symptoms of these non-life threatening conditions are routinely treated with life threatening, life altering devices. This is not a surgical procedure issue. This is a dangerous medical device issue. As Public Citizen has called for, the solution is a complete recall of these very harmful devices.
Truth in Medicine supports the petition of Public Citizen pursuant to the Medical Device Amendments to the federal Food, Drug, and Cosmetic Act, 21 U.S.C. 360f and 360h, and 21 C.F.R. 10.30, 810, and 895 to immediately 1) ban the marketing of all currently available non-absorbable surgical mesh products specifically designed and labeled for trans-vaginal repair of pelvic organ prolapse (POP) 2) recall all surgical mesh products currently on the market available for POP and 3) that all proposed future POP products be classified as a class III device only approved through the premarket approval process.
Truth in Medicine Incorporated
Lana C. Keeton
Lana C. Keeton
President & Founder
901 Pennsylvania Avenue, Suite 3-423
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