By DENISE JACOBS, CRNA, ARNP
SEPTEMBER 9, 2011
Dear Dr. Shuren, Dr Lerner, CDRH members, and Obstetrics and Gynecology Medical Devices Panel,
Thank you for inviting us here today so that we can voice our opinions and experiences about transvaginal mesh (TVM) used in pelvic organ prolapsed (POP) and stress urinary incontinence (SUI) repairs. I have no financial incentives to disclose.
I am speaking as a nurse practitioner and as a patient who was seriously injured by synthetic surgical mesh. I am interested in promoting patient safety and informed consent, which is not possible without premarketing randomized clinical trials (RCT’s). I spoke at the Institute of Medicine (IOM) last year when they met to evaluate the FDA’ s 510(k) clearance process and I want to thank the committee for recognizing that more emphasis should be placed on patient safety. I commend Public Citizen, a consumer advocacy group, for its recent petition to the FDA and HHS requesting a ban on transvaginal mesh for pelvic organ prolapse (POP), backing up their stance with a well-researched and written paper(1). The FDA’s 510(k) clearance process has allowed thousands of people, who may be expendable to industry, but who are not expendable to their families, friends, and communities, to be seriously, and sometimes permanently, harmed.
The 510(k) process has failed American people when it comes to synthetic surgical mesh, especially with the dramatic spread of new ways to use it, one-size fits all “mesh kits” and newer instruments used to place it.
Some mesh proponent surgeons disagree with the FDA’s conclusions regarding the increased warnings for transvaginal mesh used in POP. They opt that the FDA is misleading the public into believing that TVM surgery has more risks than traditional native tissue repair but that is not really the issue(2). The issue is the damage and pain inflicted by the mesh itself. These surgeons even state in their paper that “The risk of mesh erosion is unique to repairs utilizing mesh, and does not exist in traditional non-mesh pelvic surgery”(3). This is exactly the reason I propose that mesh used for SUI should have the same increased warnings as mesh used for POP and that ALL surgical mesh should be reclassified to Class III products. Doctors and surgeons must realize that this is a MEDICAL DEVICE SAFETY ISSUE, not a doctor practice issue. The fact that the Government Accountability Office (GAO), the Institute of Medicine (IOM), and Congress’s Special Senate Committee on Aging have all been compelled to look into the situation is an indication that there are severe problems with it.
One of the reasons for this meeting is to help determine if TVM for SUI should have the same increased warnings placed on it as TVM for POP. My first response is “You must be kidding! Of course, it should!”. The problems and pain from synthetic surgical mesh placed beneath the urethra are no less than those encountered when mesh is placed elsewhere in the pelvis. When a sling is “too tight” or in the urethral wall, it can cause severe urinary symptoms such as retention, horrible urgency and frequency, and painful bladder or urethral spasms, and repeated urinary tract infections (UTI’s).
Some doctors think that snipping the mesh in the middle beneath the urethra will “fix” the problem but then the ends are left free to migrate or fold back on themselves. Women I know who have had their mesh “released” in this way just ended up with other, different problems that resurfaced later on. No studies that I am aware of address the best way to handle this and there doesn’t seem to be much discussion on it in the literature. When mesh erodes into the urethral wall or damages a nearby nerve, “unbearable” is a good word to describe the 24/7 type of pain felt that increases every time that person urinates- the kind of pain that gives one goosebumps and makes one shudder.
“Meshies” are mesh-harmed people who coined the term, “ECP, which stands for “excruciating crotch pain” and describes the “kicked in the crotch by a horse” feeling resulting from a damaged pudendal nerve or mesh that has adhered to the pubic bone. When mesh is through your obturator muscle, a muscle you previously never realized that you had, then you suddenly fall easily, have constant inner thigh and groin pain, difficulty walking, and always seem to be off-balance. And that’s if you are one of the lucky ones who can still walk without a cane. Your inner thighs feel so weak, shaky, and painful that you can only go from sitting to standing with much difficulty and you can have a stabbing “ice pick” type of sensation with each and every step. You can have increased pain with sitting or any increased activity, including sex.
Women with TVM for SUI can also endure repeated surgeries, invasive office procedures, and months or years of pelvic physical therapy, just like women with mesh for POP. All of these horrific problems from SUI mesh! Who is protecting these women? Where are the premarketing trials? I strongly urge that adoption of the same increased warnings that POP TVM received on July 13, 2011, be extended to TVM for SUI.
This meeting is also about whether mesh should be reclassified from a Class II medical device to a Class III device, thus requiring premarketing clinical trials and postmarketing follow-up. My answer to that is that it already should have been classified that way. Class III devices are those that are deemed by the FDA to present “an unreasonable and substantial risk of illness or injury”(4). If surgical mesh, including newer ways of inserting it, using new and different instruments, had already been a Class III device, then adequately designed premarketing clinical trials would have already been done and many innocent people would have been spared physical infirmity, torturous pain, misunderstanding by medical professionals, sexual dysfunction, and emotional distress, including PTSD and clinical depression, related to their unexpected and severe health problems and pain. My opinion is that ALL surgical mesh, whether it be transvaginal, abdominal, for hernia repair, or any other use should be reclassified to Class III and be required to undergo premarketing trials and have post marketing follow-up.
I would like to address vaginal mesh erosion. Eroding mesh is an implanted human torture device that can cause HORRIFIC pain long before it can be visualized or felt during a pelvic exam or seen during a cystoscopy.
Of course, mesh is not well visualized with CT Scan or MRI and the use of ultrasound to visualize it has only been more recently investigated (2010) and written about in the literature(5). Some meshies describe themselves as having been mutilated by mesh or having been raped by it. They describe it as a mesh monster. To every doctor who has ever told their patient that mesh “doesn’t cause pain” I say “Shame on you”! Mesh kits use instruments that literally bore blindly through tissue and everyone does not have the exact same anatomy.
I am here to tell you that if mesh is anchored through a muscle, next to or through a nerve, eroding through pelvic tissue, in the urethral wall, or adhered to the pelvic bone or obturator fossa, it most certainly CAN AND DOES CAUSE PAIN! There can also be pain from the increased local inflammation and resulting swelling. For whatever reason, some doctors seem to treat this part of a female’s anatomy as if it has no feeling or sensation. They talk about removing vaginal mesh or sewing over a skin flap in the office as if one is going in for a teeth cleaning.
They would like you to believe that vaginal mesh erosion is not really that big a deal and it was recently described by a doctor in a news report as “peeking through the tissue”(6), a cute and non-threatening way of describing a complication that many women find physically and emotionally devastating. Just imagine if you had synthetic mesh “peeking” through the skin in your armpit, neck, or face. People would be mortified! Imagine having a screen like mesh eroding through your armpit causing constant irritation, stabbing and grating pains, and muscle spasms every time you tried to lift anything or brush your hair or drive, and constant achy pressure at rest. This is what meshies face every day, only it is in their pelvis and their privates. The disconnect with this concept alone is an example that shows that mesh should be reclassified as a Class III device.
Another area that requires further investigation is the severe foreign body reaction (FBR) that seems to result in systemic activation of the immune system that many mesh harmed people report. It has been said that polypropylene mesh is inert but the experiences of many people suggest otherwise. The activation of immune system then causes many other symptoms such as itchy rashes, boil-like lesions, generalized swelling and fluid retention with frequent complaints of a “pregnant belly look”, high blood pressure, and development or exacerbation of other auto-immune syndromes such as thyroid dysfunction, fibromyalgia, lupus, and diabetes. Blood clots leading to stroke, loss of legs, and death have also been reported. Where are the clinical trials on any systemic reactions to synthetic mesh?
In closing, as an injured patient and nurse advocate for patient safety and informed consent, I strongly believe that transvaginal mesh for SUI should have the same increased warnings as transvaginal mesh for POP. My opinion is that all mesh in the body is a medical device that is capable of causing severe and permanent injury; therefore, all surgical mesh should be classified as Class III devices and be required to undergo adequate clinical trials and postmarketing follow-up.
Thank you for allowing me the opportunity to speak my honest thoughts about this very serious topic that potentially affects so many people in such profound ways. I sincerely hope that more emphasis is placed on patient safety and informed consent than what we have experienced in the past.
Denise Jacobs, CRNA, ARNP
(1) Public Citizen Petition, Consumer Advocacy Group (August 25,2011), 1600
20th Street, Washington D.C., 20009, www.citizen.org
(2), (3) Prolapse Surgeons Network, Time to Rethink: an Evidence-Based
Response from Pelvic Surgeons to the “FDA Safety Communication: Update
on Serious Complications Associated with Transvaginal Placement of Surgical
Mesh for Pelvic Organ Prolapse” (August 5, 2011)
(4) FDA U.S. Food and Drug Administration Guidance Documents (Medical
Devices and Radiation-Emitting Products), Evaluation of Automatic Class III
Designation, Guidance for Industry and CDRH Staff, Section 207 (FDAMA);
Section 513 (f)(2) of the FDCA; 21 USC 360c(f)(2)
(5) Kobashi K, MD (2010) reported to Uro Today. Presented by Staak A, MD,
Baxter C, MD, Lee U, MD, Morrisroe S, MD, Kim J, MD, Rodriguez L, MD,
and Raz S, MD (May 29-June 3, 2010) American Urological Association
(AUA) Annual Meeting Impact of translabial ultrasound on diagnosis and
treatment of mesh related complications- session highlights. San Francisco, CA,
(6) wCAX.com/HealthWatch: Warning about pelvic mesh (July 15, 2011),
Alexis Christoforous @ CBS News, http://www.wcax.com/story/15090619/awarning-