Mesh News Desk, March 14, 2016 ~ Noni Wideman, a survivor of a polypropylene mesh implant, writes the following letter to Consumers Union. CU and specifically Lisa McGiffert have been involved in the pelvic mesh issue through Safe Patient Project, proposing that medical devices carry a warranty not unlike the refrigerator you buy. Makes sense!
email sent March,12, 2016
Washington DC Office
1101 17th Street NW, Suite 500
Washington, DC 20036
Phone: (202) 462-6262
Fax: (202) 265-9548
from Nonie Wideman
I am an advocate for women with medical mesh implant injuries.
My heart almost skipped a beat when I read the following: “Consumers Union is the policy and action division of Consumer Reports. We work with our million plus activists to pass consumer protection laws in states and in Congress. We hammer corporations that do wrong by their customers, and encourage companies that are heading in the right direction.”
Boy, oh boy! I urgently need your help to hammer some corporations and entities that have done wrong to their customers, done wrong to the patients they were supposed to protect. I have been tweeting, along with other women harmed by dangerous medical implant materials and devices, #FDA#JNJ#HARMS#WOMEN.
I'm filled with hope that the Consumers Union can change the worst flagrant intolerable marginalization of women's healthcare since the dark ages.
Tens of thousands of women have come forward in the past three years to report significant harm done to them when implanted with dangerous, medical mesh products to treat prolapse (POP), stress urinary incontinence (SUI), hernias, and thousands of young women have been implanted with Essure sterilization coils. I would be remiss to not include the men, who also have been harmed by the hernia mesh products. Millions of men and women have been implanted with synthetic mesh for hernia repair. It is the most done surgery. Over 300,000 women have been treated for POP and SUI per year in recent years. Most of the repairs are done with synthetic surgical mesh. Essure coils have killed women, fetuses, and caused need for too many young women to have hysterectomies.
The systemic response to coils are causing autoimmune disease symptoms in these young women. Polypropylene mesh implant complications have killed women. The pain from mesh complications has caused suicide, suicidal depression, perforations into other organs, erosions, extrusions of mesh out of vaginas, adhesions, and like in the group of 20,000 Essure harmed women, the systemic response to the mesh complications have caused higher rates of autoimmune symptoms and confirmed autoimmune diseases post mesh complications.
Adverse events caused by medical implant materials and devices are notoriously under reported. One would think with over 100,000 lawsuits over transvaginal mesh tapes (TVT) and materials, there would be 100,000 adverse events reported to the FDA, reports made by primary care givers and surgeons.
The numbers of mesh cases in litigation far exceeds the number of adverse event reports. We all know the reasons for under reporting. (It's called ass covering.) It's to avoid responsibility, avoid litigation. It is also ignorance, misdiagnosis that causes under reporting. The true number of mesh injuries will never be known, because it was not mandatory to report every problem attributed to mesh implants.
Reporting is discretionary and subjective to interpretation. Doctors who are not trained to look for damaging chronic foreign response to these implant materials, seldom recognize or understand the ongoing foreign body driven injury inside their patients bodies. Women in pelvic pain have been sent to psychiatrists, when, what they really needed was a urogynecologist to remove their degrading, folding , nerve entrapping, shrinking, biofilm covered infected mesh implants.
Arrogance by the medical community to listen to the voices of those most impacted by the adverse events occurring after being implanted with non-inert PP mesh is rampant. Arrogance, by the FDA to admit women know more about their own body’s response to mesh far exceeds the knowledge that many of the surgeons who implanted the synthetic mesh have, is insulting. We do not need patriarchal platitudes and condescending attitudes. We need protection from poorly, and understudied, and often untested permanent implant materials being allowed on the market by the faulty 510K process.
The FDA reclassification of transvaginal mesh for POP repair to a class 3 needing premarket approval (PMA) is a step in the right direction.
This reclassification proposal came too late, and does not go far enough to protect all women with transvaginal mesh implants. More than half the litigation over mesh is for the SUI mesh, and yet the FDA in its lack of wisdom failed to include SUI mesh products in the reclassification.
Patient's voices should be heard above those that stand to continue to profit from the use of poorly tested, understudied defective mesh products. If a product does not remain inert in all of the people it is implanted into it must be considered defective as it does not perform as intended. If an implant product can degrade and leach chemicals into the host body, that is not acceptable and it should be considered defective. Furthermore if no other biocompatible tissue scaffolding material is available to use to benefit a patient, the synthetic implant material or device should be considered a high risk material or device.
Polymeric SUI mesh products degrade and fragment exactly the same way POP mesh implants do. They are made of exactly the same polymeric materials. When looking at all the uses of polypropylene mesh materials and noticing that close to 30% in each type of use, (for SUI and POP repair) have complications it is apparent that a large subset of the population are hypersensitive to synthetic implant materials and it would seem necessary to do more studies and testing to see what biomarkers this group of patients have that puts them at a higher risk of complications.
An Ethicon brochure for doctors regarding their product said an underlying autoimmune disorder is a contradiction for use. With a historic record of not telling the whole truth and down playing risk it makes patients researching wonder what else Ethicon did not tell us about the links between autoimmune problems and their mesh products?
What makes the injury of SUI mesh patients less disastrous than those with POP mesh implants that go wrong? Granted the women with POP mesh implants have more product implanted but the response when you are “allergic” to the implant material is equally painful, and quality of life destroying even with a smaller quantity of an allergen inducing product. If you are highly allergic it matters not the amount of allergen.
Consider a bee sting, for a hyper-reactive person, one sting can kill you. You don't need two dozen bees to sting you to die, you just may die faster. If your body is hypersensitive it really does not matter that the piece of polypropylene is large or small. A person that is chemically sensitive with a SUI mesh may have more problems than a less sensitive patient with a larger amount of mesh. I urge you to not exclude SUI mesh from this proposal.
The polymeric meshes degrade in different parts of the body in the same way, no matter where placed or the skill of the surgeon when it is the host response to the properties of the mesh that cause the cascading complications. However I would dare say the mechanical irritation of mesh in a constant wound created by FBR in a vagina and pelvic floor may be harder to endure than the abdominal pain of hernia mesh contraction and nerve entrapment.
I have not had a hernia repair with synthetic mesh, but I can testify to the excruciating pain of a SUI, TVT Secur implant eroding into my urethra and bladder and extruding from my vagina. I can testify to the lack of skill of doctors to recognize and diagnose the complications in a timely fashion to prevent permanent nerve damage. I can testify to the fear you feel when your urine contains blue fibers and your urethra feels like it is on fire and the tests for infection come back negative. Three years of cascading systemic health problems post mesh implantation, then 8 months of excruciating constant pain, nine doctors later I had the mesh removed. I live with pain every day. There was no transient foreign body reaction. The foreign body reaction was constant and it increased with time. I begged the FDA to not exclude SUI mesh from reclassification. I provided studies and facts and figures.
The scar tissue created by mesh is proven to entrap nerves causing often irreversible pain. Doctors know this, the FDA knows this. When the nerve damage (compression, erosion, chemical and mechanical irritation) is to the sensitive pudendal nerves that impact sexual function, urinary function, and bowel function, the results can be catastrophic. The foreign body response to mesh experienced by the large cohort of patients that are hypersensitive to foreign body implants does not appear any different in hernia patients, POP patients, or SUI patients. Nor is the foreign body response to Essure coils any different.
The mesh contraction in hernia mesh products, POP mesh products, SUI mesh products, is the same. The leachates from polymeric meshes, such as the hydroxyls are the same, the free radical damage from the degradation of PP mesh is the same, the loss of quality of life is the same. I urged the FDA to not exclude SUI mesh from reclassification to level 3.
I urged the FDA to, in the very near future, to consider adding hernia mesh to class 3 also. If there is no reason for doctors to change their perception of the safety of synthetic mesh there will be no hurry to find alternative structural support materials that are more compatible.
Class 3 status for synthetic mesh implants, or any permanently implanted device or material in the minds of most mesh complication victims is a compromise. It is not a ban on the implant materials, which many feel is appropriate, but a compromise. It would be an added safety feature that makes scrutiny more intense on what patients will benefit from the use of the synthetic meshes and those that will be harmed more than they will ever be helped.
If the FDA continues to view these permanent implant devices and materials in the same class as syringes shame on them. It does not take a scientist to figure out there is a difference between the stability of a product to remain inert and be biocompatible in the body of the patient it is implanted into, and the functioning of products not permanently implanted into people. There are more safety warnings about drugs that can be immediately withdrawn than there are for medical device implants that are nearly impossible to remove, taking many surgeries to remove, causing horrendous costs in pain and suffering to patients as well as the added costs to the health care insurance providers.
The FDA failed to act fast enough to prevent injury to the 30% of patients who have experienced adverse reactions to synthetic mesh implants. It is common knowledge that the mesh complications are under reported and minimalized. Women are just now educating themselves as to what has happened to them. Most women have had to self-diagnose their pelvic pain and then fight to have doctors listen to them and act upon the information they have brought to their doctors . Too many doctors do not recognize the first symptoms of chronic FBR and they are unprepared to manage the complications with skill and expediency. That is a shameful response to the warnings the FDA put out to the medical community. The warnings were not strong enough.
Far better it would be if patients were the first ones notified when warnings come out about the devices or materials put into them, put into them with permanence as an objective, with no protocol on how to monitor the performance of the materials or devices. Patients when notified could take their product info to their primary caregiver and then scrutiny could and should follow.
The person who has the most to lose or gain would following up on warnings, not the persons on the defence for using risky materials before benefit over risk was established. The car manufacturing business has better recall features that the medical community does for defective parts and implant materials. The FDA must be forced to classify all permanent implants as class 3 products. It is common sense.
The manufacturers of medical implant materials have profited from the sales of these products and therefore need to bear the cost of testing and studies. Right now, hundreds of thousands of patients are bearing the cost of inadequate testing and researching, and fast tracked products based on predicate devices that were recalled. The cost these patients pay, that hurt the most, are not measured in dollars , but in pain, loss of life, loss of quality of life, loss of independence, relationships and the most valuable of assets loss of health and happiness. The families of these patients suffer along with them. To not include SUI mesh products in the reclassification proposal was abysmally wrong.
Mesh is mesh is mesh.
Biomaterials have been proven to have an adjuvant effect. When foreign body reaction is expected to be transient there is an expected end to the foreign body reaction process and an acceptance or tolerance of the biomaterial. There are no studies that investigated the consequences or impact to the patient when their autoimmune system is activated constantly by chronic foreign body reaction that is strong enough to degrade an implant device or material and cause device failure.
Causal evidence is piling up to link chronic foreign body reaction causing mesh complications to the development of autoimmune disease in the cohort of patients who have hypersensitive immune systems. When you have no protocol to test for hypersensitivity, and it is not suggested to test for sensitivity, not suggested by mesh manufacturers as due diligence when discerning which patients it is a gamble to implant with synthetic materials, or which patient it appears to be safe for, it just another logical reason why all transvaginal synthetic products need to be class 3.
We must not allow the FDA to exempt SUI implant materials from the class 3 proposal.
When there are concerns that the leachates from polypropylene mesh degradation may have an estrogenic effect in the human body, the effect of estrogen on some estrogen driven cancers is more than disconcerting. Inflammation, stress, toxic chemicals, and infection, are all linked to autoimmune pathogenesis. How many mesh complication patients do not have erosion, extrusions, infections, pain, stress, chronic inflammation, and chronic wounds around mesh? What is the acceptable rate for complications?
When I was told complications are rare for this minimally invasive procedure, I calculated the risk as the same as winning the lottery. The benefits appeared to outweigh any distant rare warnings. Rare? Obviously the studies were not adequate and this underscores the necessity of reclassifying any permanent implant device or material as class 3. I trusted my doctor, and I believe he trusted the manufacturers.
The FDA is abundantly aware of the loopholes in its 510 k system. When a product is recalled all the subsequent products substantially equal to the predicate device should be recalled also. For if they are substantially equivalent it stands to reason they are substantially defective. Each permanent implant by virtue of the permanency factor should only gain clearance by the FDA by virtue of its own properties, where long term studies have proven benefit over risk, where cytotoxicity, and biodegradation tests will indicate the materials will stay inert invitro for the life expectancy of all the patient implanted with the material or device, not just 70% of the patients.
When researching I found out these lifetime permanent products for patients have a shelf life expiry date. If these products have a shelf life expiry date what does this tell patients? If the products crumble and fray before they are implanted, as has been discovered, how did doctors and manufacturers expect the material to withstand the oxidative process of the human body when it will not accept the polypropylene mesh, and tries constantly to degrade and expel it?
Why is it patients are not privy to what chemicals and additives are in the implant materials in their bodies? Does the FDA even know what chemicals are leaching out of polypropylene? When many women with mesh complications are being diagnosed with Lupus and other autoimmune disorders post mesh implantation at a higher rate than the general population we have a right to know what our bodies are reacting to and exposed to.
Adjuvants have caused autoimmune disorders. Biomaterials have been proven to have an adjuvant effect. Studies should have been done regarding this and they need to happen now, because these types of studies didn't happen when they should have, before the products were cleared by the FDA. This is why polymeric biomaterial meshes need to be reclassified to level 3. What difference is there between the FBR to SUI placed mesh and POP placed mesh? None except for perhaps abdominally placed mesh would be less likely to be contaminated.
The vaginal placement of transvaginal mesh is a clean contaminated field. SUI placed mesh is inserted into this less than pristine environment and therefore it may be subject to more chance of infection than abdominally placed meshes, so I argue that SUI meshes need to be included in the proposal for class 3 status and regulations. When meshes have biofilms that cause a chronic infected state is it any wonder immune system get exhausted and adrenal fatigue is common for patients in constant pain?
I believe it is safe to say hundreds of thousands of women are sharing research, information and experiences with brutal honesty. They feel violated, like a group of misogynists invented mesh to torture them. Social media is a powerful tool and as more and more women globally join forces and dig deep into medical journals and abstracts and reviews there is a growing anger at what has been allowed to continue for too long. We expected better from the FDA. We deserved better from the FDA.
Any suspected adverse reaction to an implant material or device should be mandatory to report. When patients report adverse reactions and there is no number to match by doctors there should be a review of the patient’s doctors. Self-protectionism by doctors is not acceptable at the expense of patient’s health and lives. If mistakes and concerns are not reported we cannot learn from them. We cannot fix what do not realize is happening. There is a disconnect between patients of specialists, because after surgery, and consultations, patients return to their primary care givers who may not be aware of what to monitor and watch for.
I believe the manufacturers of mesh implants are the first to blame for our misery, the FDA is the second to blame, the doctors the next to blame. For such a highly educated group of professionals to allow such an unacceptable situation to go this long, allowing so many lives to be harmed, is hard to forgive let alone comprehend.
It is my belief it is the duty of the FDA to err on the side of caution and classify POP mesh, and SUI surgical mesh as level 3 products. Furthermore I believe millions of hernia mesh patients would support classifying surgical mesh for hernia procedures be classified at the same level. The FDA needs to be forced to use its power to protect patients first and foremost. A half measure discriminatory safety net is not good enough.
Your sincerely Nonie Wideman,
voice for Canadian Victims of Transvaginal Mesh
advocate for medical mesh complication patients in BC Canada
moderator for Links on Mesh forum, 1015+ members
creator of Links to Medical Mesh Research www.meshproblems.weebly.com
contributor to Medical Mesh Device News Desk website
research contributor to TVT NO Org.
Survivor of TVT Secur complications
author of The Links Between Surgical Mesh Complications and the Development of Autoimmune Disease
Safe Patient Project
Consumers Union Brings Eight Activists to Congress, February 2012
Consumers Union Warns the FDA Cannot Protect Patients, May 2012
Consumers Union on Improving the Safety of Medical Devices, February 2012
Consumers Union: Manufacturers Should Warranty Knees and Hips, September 2013