Mesh Medical Device Newsdesk

MDL News: 21,257 Cases Filed in Federal Transvaginal Mesh Litigation

Jane Akre — Fri, 24 May 2013 18:37:20 +0000

May 24, 2013 ~ A meeting in Charleston, West Virginia yesterday, where about 20,000 transvaginal mesh lawsuits have been consolidated, yielded an tentative agreement on tolling agreements.

Under law, a tolling agreement suspends for a period of time, the statute of limitations. In this case, the July, 2013 two-year statute of limitations date will be extended a number of months. That means potential plaintiffs who think it may be too late to file a case against any of the five mesh makers will have extra time to file.

The ruling was issued to avoid a log jam of mass filings in the federal court by those trying to make some deadline.

If you are thinking of filing a case with one of the law firms involved in litigation here, it is suggested to fill out the necessary papers to move it along. The website has a listing of the rulings and the various law firms involved. These are likely the firms of trial lawyers who do the legwork to prepare a case.

Smaller firms may eventually pass your case to one of these larger firms.

Judge Joseph Goodwin

Multidistrict litigation (MDL) allows for cases from all over the country to be heard by one judge, in this case The Honorable Judge Joseph R. Goodwin, to allow for consistent rulings so cases can move through the courts more quickly. They can still be tried individually but the MDL addresses all of the housework such as depositions and the filing of motion that precedes an actual jury trial.

The five defendants are Ethicon (Johnson & Johnson), C.R. Bard, American Medical Systems, Boston Scientific and Coloplast.

Here is the So. District of West Virginia website and the number of cases filed as of May 22, 2013.

MDL No. 2187 C.R. Bard, Inc. with 3,349 cases filed.

MDL No. 2325 American Medical Systems (AMS), Inc. with 6,781 cases filed.

MDL No. 2326 Boston Scientific, Inc. with 4,157 cases filed.

MDL No. 2327 Ethicon, Inc. with 6,550 cases filed

MDL No. 2387 Coloplast Corp. with 420 cases filed.

TOTAL NUMBER OF CASES FILED IN FEDERAL COURT IN WV = 21,257

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C.R. Bard Lawsuits: Rulings Reveal Company Secrets

Jane Akre — Thu, 23 May 2013 18:01:47 +0000

May 23, 2013 ~ Buried inside some rather routine motions filed in the upcoming federal lawsuits filed in federal court in Charleston, West Virginia are some company secrets that C.R. Bard would rather keep secret.

In Order #77 Plaintiffs want to take the deposition of C.R. Bard executives Roger Darois and Dan LaFever. The court denies the motion as moot, granting in part and denying in part a 189 motion by Carolyn Jones for Leave to take the supplemental deposition of Mr. Darois, but may not depose Mr. LaFever.

The motion reopens discovery for the purpose of deposing Darois about email communications. Roger Darois is the Vice President of Research and Advanced Technologies for Davol, a subsidiary of C.R. Bard, Inc. based in Murray Hill, New Jersey.

This is a supplemental deposition. In the first deposition of Mr. Darois, lawyers discovered two chain emails where he discusses the issue of raw polypropylene resin used during mesh production. Enclosed in a Material Safety Data Sheet (MSDS), resin is not to be used in medical devices that are permanently implanted in the human body.

“Contrary to this warning, Defendant used the resin in its mesh products, which were specifically intended for permanent implantation.”

“Plaintiffs claim further that the email chains reveal Defendant’s deliberate intent to conceal its improper use of the resin from the manufacturer, Phillips Sumika, for fear that Phillips Sumika would not supply the resin if it understood Defendant’s intended application.”

The motion says Bard realized that Phillips Sumika probably knew it made medical devices, so as a diversion, Bard created a wholly-owned subsidiary Red Oak Sales Company, that purchased resin from Phillips Sumika “without creating suspicion about its use.”

Plaintiffs argue this information is “highly relevant to their case.”

Dan LaFever’s deposition is also sought, He is the President of Davol and was a party to the email communications, according to the plaintiffs. “His deposition is important to explore the relationship between Davol and Red Oak, his knowledge of these issue [sic] and why he would allow such nefarious conduct.”

This motion tells the court that the email communication in question were not produced by the Defendant until November 26, 2012 and December 4, 2012 “leaving Plaintiffs with insufficient time to review and digest them before Mr. Darois’s deposition on December 19, 2012.”

Judge Joseph Goodwin

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Mesh Fails 25 Percent of Time in Vaginal Prolapse Repair

Jane Akre — Wed, 15 May 2013 06:02:37 +0000

Ingrid Nygaard

May 15, 2013 ~ Bloomberg (here) reports surgery to treat pelvic organ prolapse failed about 25 percent of the time within seven years.

Reported in the May 15^th Journal of the American Medical Association (JAMA) this is the longest look ever to determine how those who undergo pelvic organ prolapse (POP) repair fared in the long-term.

Sacrocolpopexy, U of VA Health Services

In this case, the treatment involved abdominal sacrocolpopexy, abdominal surgery implanting a surgical mesh to correct POP, not transvaginal repair where a surgeon implants a mesh product through the vagina. Doctors generally agree there are fewer complications with an abdominal approach because the vagina is considered a “clean contaminated” field that may introduce bacteria into the mesh site.

About 225,000 women undergo surgery receiving the permanently implanted polypropylene mesh to hold up a uterus, vagina, rectum or bladder and urethra. Abdominal sacralcolpopexy is considered the most durable surgery but little was known about long-term effectiveness and how additional incontinence surgery using stitches only (Burch urethropexy) would affected the long-term outcome.

Women enrolled in the CARE study (215) had the abdominal sacrocolpopexy procedure between 2002 and 2005. Half had abdominal sacrocolpopexy and the Burch procedure and 111 had the sacrocolpopexy alone.

The results showed the surgery failed to secure the organs one-quarter of the time. Within seven years the prolapsed organs – uterus, vaginal wall or rectum prolapsed through the vagina for 48 percent of women, considered a symptomatic as well as anatomic failure.

Mesh erosion was a problem as well in about 10.5 percent of the patients at seven years. For 81 percent, there was a return of incontinence among those who did not have a second procedure. For women who did have a second procedure, incontinence returned in 75 percent of the women. The quality-of-life issue of pain did not seem to be among the criteria judged.

“The surgery that is considered to be the most durable and effective for pelvic organ prolapse fails to restore normal anatomy in one out of four women,” said researcher Ingrid Nygaard to Bloomberg. She is a professor of obstetrics and gynecology at the University of Utah School of Medicine.

The study concluded that most women had improved health immediately following surgery but the “fix” is a temporary one. There is no information on how women fared outside of the seven years but the rates of failure increased during the duration of the trial.

Most women are told synthetic surgical mesh is the “gold standard” however this study finds it is not the miracle cure that is promised and the risks may not be worth the benefits.

More on Ingrid Nygaard:
http://healthcare.utah.edu/fad/mddetail.php?physicianID=u0513310

Here is a press release on the study:
http://www.eurekalert.org/pub_releases/2013-05/tjnj-sel050913.php

JAMA study:
http://media.jamanetwork.com/news-item/study-evaluates-long-term-effectiveness-of-surgery-for-pelvic-organ-prolapse/

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Teapapers on Immune Boosters

Jane Akre — Tue, 14 May 2013 17:00:17 +0000

May 14, 2013~ Linda K. is still recovering from surgery to reconstruct her urethra using her own fascia. This followed her mesh removal surgery last year.

See her October 2011 MDND profile here.

As has been the case for three years, infection continues to be a problem. While she is not a medical professional, Linda K wants to share the natural remedies she uses to fight infection.

These herbs may compliment prescription drugs but be sure to check with a physician.

See Linda’s well visited Teapapers blog here:

http://teapapers.com/bladdersling/2013/05/mesh-my-triple-three/

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Saskatchewan Protest Over Mesh

Jane Akre — Mon, 13 May 2013 03:43:56 +0000

May 11, 2013 ~ A group gathered outside a Saskatoon City Hospital Saturday to bring awareness to the dangers of polypropylene surgical mesh. Synthetic mesh is often used as a first-line treatment for incontinence or pelvic organ prolapse (POP) however the women who have had the treatment want to warn others away from that option.

“It’s like a vice grip clamping onto my stomach with, like, razor blades on it said Marika English to CBC News (here).

English has paid $30,000 to travel to UCLA’s urology department to have the mesh removed. The world renowned facility is one of the few in the world with success in the complete removal of synthetic surgical mesh. Canada has options for partial mesh removals so women have petitioned their provincial government to have it pay the thousands necessary to remove the implants in the U.S. Mesh is designed to be a permanent medical device.

Stephanie Brad, who was also at the Saskatoon hospital, also plans to spend whatever it takes to have her mesh removed. She says she can’t walk, sit or do much with her kids because she is in so much pain.

Both English and Brad want the provincial government to at the very least warn women about the procedure. They would prefer to have it removed from the market.

Estimates are up one-third of mesh implants may eventually result in complications such as mesh erosion, pain, nerve damage, infection and migration.

Thousands of Canadians whose problems are being dismissed and ignored have created the website here. Supporters are asked to sign a petition. and ask them to sign the petition there.

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Carpenter v. American Medical Systems Trial Delayed

Jane Akre — Wed, 08 May 2013 19:16:46 +0000

Stewart Albertson, Albertson & Davidson

May 8, 2013 ~ The trial of Marion Carpenter v. American Medical Systems which was scheduled to begin in San Bernardino California, May 13th, has been delayed until January or February of 2014.

Attorney Stewart Albertson tells MDND that decision was made by both sides appearing before Judge Bryan F. Foster, in the San Bernardino Central Courthouse. Read yesterday’s story and complaint here.

“She’s frustrated and I am too. She’s been through a lot but this is the best for the case,” says Albertson. “It’s not something we enjoy doing but the circumstances pulled together with our analysis of the solvency led us to believe this is the best course,” says Mr. Albertson referring to the financial health of AMS, which was purchased by Endo Holdings two years ago.

What do we know about Marion Carpenter? She is age 51 and was a registered nurse making about $80-90,000 a year during the last three year she worked before she was implanted with a Monarc sling to treat incontinence. Carpenter was said to have never missed a day of work. Her attorney says her coworkers loved her and after surgery noticed how much pain she was in which caused her to miss work.

“So it’s effectively destroyed her career,” says Albertson.

Her husband has passed away. After three surgeries with Dr. Shlomo Raz, a urologist at UCLA, he opined in his deposition that Carpenter would never have normal sexual intercourse again. The surgeon found permanent nerve damage and profound scarring after removing as much of the Monarc mesh as he could.

“He had to do a lot of dissection to get that stuff. She still has chronic infections but the doctor says you can never get it all out, it’s impossible,” according to Albertson.

Endo Health Solutions Inc. of Malvern, Pennsylvania diversified into medical devices for urology with its purchase of American Medical Systems in April 2011 for an estimated $2.6 billion ($30 a share), according to the Wall Street Journal (here).

That deal included about $312 million in assumed debt. Endo purchased not only surgical mesh for male and female incontinence, but also a laser system to treat enlarged prostates and erectile dysfunction. Endo also purchased Qualitest Pharmaceuticals $1.2 billion and $223 million for urology products company HealthTronics.

Read more in this April 2011 story from Bloomberg (here).

More on American Medical Systems Inc. of Minnetonka MN
http://www.endo.com/solutions/ams

Quarterly filing May 2013
http://www.endo.com/investors/sec-filings

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Scotland’s The Sunday Mail: The Pain is All in Your Head

Jane Akre — Wed, 08 May 2013 17:30:57 +0000

May 8, 2013 ~ by MARION SCOTT~As Scotland’s mesh victims go to parliament to meet with Health Secretary Alex Neil, one mum reveals how she planned to take her own life after doctors told her the pain was all in her head.

Karen Neil’s courageous account of how mesh implants drove her to suicide shows just how desperate victims have become.

Karen was sent to see a psychologist when her surgeon refused to accept that the implants were causing her agonizing pain.

Victims are asking for a raft of new proposals, including an implant register, which will provide a new level of protection for patients.

Read the articles by Marion Scott, May 5, 2013.

Here

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Next Trial – May 13: Carpenter v. AMS

Jane Akre — Wed, 08 May 2013 04:22:27 +0000

May 7, 2013 ~ The Marion Carpenter v American Medical Systems
product liability trial is set to begin in San Bernardino County California on May 13.

Carpenter has filed a medical malpractice action against her doctors and a products liability action against American Medical System. She is represented by Stewart Albertson of Albertson & Davidson (here).

Here is the complaint: Carpenter v AMS.

Marion Carpenter lives in San Bernardino County, California. AMS is a Delaware company.

The doctors named are Jeffrey S. Hardesty MD and Sam Siddighi MD.

Carpenter had the Monarc Subfascial Hammock (Monarc) (here) implanted to treat incontinence March 4, 2008. According to the complaint, the doctors:

“failed to exercise the proper degree of knowledge and skill and so negligently, carelessly, recklessly, wantonly and unlawfully treated, provided care, monitoring, examination and other professional services in that among other things, they failed to adequately and properly diagnose and treat Plaintiff causing Plaintiff to suffer major physical injuries to her bladder and pelvic area.”

Carpenter is is unable to work.

The complaint on Product liability:

“Defendant negligently and carelessly manufactured, designed, assembled, compounded, tested or failed to test, inspect or failed to inspect, packaged, labeled fabricated constructed analyzed distributed, serviced merchandised recommended advertised promoted marketed and sold the Monarc….. it was in a dangerous and defective condition and unsafe for the use and purpose for which it was intended when used as recommended by the Defendants.”

“Plaintiff has suffered severe and excruciating pain and distressing mental anguish.”

Background

Dr. Hardesty suggested the Monarc to Marion Carpenter to treat her incontinence and the complaint says the doctor provided her with a pamphlet. By March 20, 2008, the mesh had eroded and was exposed in Carpenter’s vagina. Dr. Hardesty surgically excised that portion of the mesh but Carpenter’s pain persisted, the complaint says.

According to the complaint, by January 12, 2009, Dr. Hardesty surgically removed the Monarc mesh. The risk of erosion was never discussed and was not in the literature. Surgeon continually assured her that her pain would improve.

MDND will be monitoring whether or not this case goes to trial on the 13th and has a request into attorney Albertson for an interview. Stay tuned! #

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The Links Between Surgical Mesh Complications and the Development of Autoimmune Diseases

Jane Akre — Tue, 07 May 2013 17:57:18 +0000

Nonie Wideman, Contributor

Greetings from Nonie Wideman, a survivor of medical complications from Foreign Body Response (FBR) to synthetic medical mesh. I have spent over 15 years advocating for children and families, over twelve of them as a specialized care provider teaching coping and life skills. I had to put into practice myself what I taught after a disastrous experience with implant failure and rejection. I had to recognize the problem, set goals to address the problem, and evaluate the effectiveness of my plan to deal with the problem.

I began relentlessly researching the “what the hell went wrong? “question regarding synthetic medical mesh complications. It appears the “what the hell went wrong” question was largely ignored, unrecognized, and minimized in the medical community and buried by manufacturers of synthetic medical mesh whom I feel definitely patted themselves on the back, for their part in improving quality of life for people having issues with prolapses, hernias and incontinence. Research revealed a lack of long term studies regarding the safety and reliability of medical mesh implants, the lack of follow up with patients receiving the aforementioned mesh products, lack of understanding by the medical community that they had regarding the rates of failure, the cause of failure, and the consequences of prolonged and chronic FBR.

I wish to challenge all my readers to question the use of synthetic medical mesh and ask for accountability from those who profited from the sale of these products at the expense of a significant number of patients living in the aftermath of synthetic medical mesh degradation and implant failure. With knowledge and truth we can join together to advocate for safety before profit. I hope to empower people to demand honest answers and demand change.

Mesh removed from LR after 3 months

The Links Between Surgical Mesh Complications and the Development of Autoimmune Diseases

by Nonie Wideman, April 2013

Background

When researching mesh complications, if one were to listen to the most knowledgeable experienced people on the subject, one would not be listening to doctors or mesh manufacturers. To know exactly what is going on it would seem prudent to first talk to, and listen carefully to, the women implanted with polypropylene meshes for prolapse (POP), stress urinary incontinence (SUI) and listening to men and women with mesh hernia repairs. In defense of their own health, to advocate for skilled medical intervention to reduce pain and gain back quality of life, they have had to research to find answers as to why they hurt, why doctors think their pain is anything but mesh related, why they are sick, why their complications are hard to diagnose, and why doctors are reluctant to diagnose what is obvious to women and men with computers, internet and Google skills. It is sad when patients have done more research than doctors.

Listening to the women with first-hand knowledge of transvaginal mesh complications, one thing is being made very clear by women; not enough attention is being paid to the systemic injury of mesh complications. When listening to hernia patients, men and women are saying mesh complications affect your whole body, not just your abdomen. According to Jonathan Blac (1984):

“Evaluation of the host response to implanted biomaterials usually focuses on the implant site tissue response. This may lead to erroneous conclusions in the same way that examination of battles outside of their historic context does. A broader view discloses a variety of possible and actual systemic effects of carcinogenic, metabolic, immunological and bacteriological nature. Recognition of these effects in patients is hampered by a lack of epidemiological studies (19).”

Researching patients found they were not alone with their questions or symptoms. Patients like me discovered they could be considered by the medical community as high responders to medical mesh. In other words we are all the population of patients experiencing chronic foreign body reaction to synthetic mesh implants. These synthetic meshes mentioned are predominately constructed of polypropylene or similar polymeric constructs. To break it down in simpler terms we all found that hypersensitivity to foreign body implants was, and is, the common denominator among us. You might say for simplicity‘s sake we high responders are all “allergic” to the materials doctors implanted in us.

With the recent trials over the injuries caused by the controversial transvaginal implants, it becomes very evident that research into the long term effects of polypropylene in human bodies is, as I have discovered, is almost non –existent. I say “almost “, because there may be some study somewhere I have missed or others have missed that would enlighten us all. Alas, I have not found long term studies that show what to expect with controversial synthetic meshes 3, 5, or 10 years into the future. Personal experience and research however indicates that complications may present with mesh implants as long as the implant remains in a live body. With the new emerging information from the FDA that indicates complications rates to be higher than predicted or thought acceptable, for benefit to risk ratios, it appears more scrutiny is needed, and was needed. Scrutiny comes late, and comes at the expense of patients’ health (5).

When synthetic mesh is surgically placed in your body, if your body is over sensitive, it matters not how skilled the surgeon is or unskilled he is at placing mesh, when it is the properties of the mesh and the body’s ensuing expected foreign body response gone awry that causes oxidative processes in the body to try degrade the foreign body enough so that cells can “eat” or dispose of the foreign matter that it can’t push out like a puss surrounded splinter. That oxidative process of chronic foreign body response has been proven to degrade polypropylene (7).

Fallen urethra and bladder, Windsor Urology UK

Polypropylene mesh does not remain inert when constantly attacked by the oxidative processes of Foreign Body Response (12).( Should mesh actually ever have been considered inert in the first place as it is recognized by the human body as a foreign body as soon as it is implanted? )

Degradation products of polypropylene are Alkyl radical, Alkoxy radical ,Peroxy radical and Hydroperoxide (1). Note that these degradation products are free radicals, and they are considered toxic. If polypropylene has been treated with other surfactants to help dye fixation as in blue dyed medical mesh, or treated with chemicals for sterilization because heat sterilization damages the mesh, then there are other degradation products to worry about. Polymeric materials have long been identified as leaching estrogenic mimicking chemicals that are known to make cancer cells multiply; for example blue polypropylene piperettes used in lab experiments were found to be the source of experiment contamination in lab research. Women are wondering about nonylphenol leaching out of meshes and its estrogenic role in enabling cancer. Scientists know polypropylene degrades under oxidative stress. Did no one think to test what chemicals could leach out and cause toxic chaos inside of peoples’ bodies? You would think because the implants were designed to be permanent, substantial testing would have occurred before marketing such medical devices. Substantial testing was not done (16).

Where am I going with this? I am listing the ingredients of a recipe for autoimmune disease to develop. It is a recipe for a systemic storm. It is a storm that also can predisposes one to cancer. Predisposition for higher rates of cancer after mesh complications, is a subject deserving of an article all of its own. This article’s purpose is to draw attention the fact that there appears to be a high rate of autoimmune disorders in the population of women with chronic FBR that has caused implant failure and degradation. I took a survey of patients with medical mesh complications that validated my suspicions and the suspicions of other patients. Many thanks go out to those who took the survey in order to get a real snapshot of what the unrecognized systemic diseases are that mesh complication patients are dealing with, seeking validation for, and seeking skilled medical intervention for. I will share survey information at the conclusion of this article.

#1 Ignorance: no biocompatibility tests

I draw your attention back to the recipe for a devastating storm. The number one ingredient in this systemic storm is ignorance. Doctors appear to have no tests to predict hypersensitivity to polypropylene in candidates for synthetic mesh implants. Hypersensitivity (which may be a genetic predisposition or an acquired condition) should be a contraindication for a patient to be implanted with a synthetic material known to cause an inflammatory response, just as having an underlying autoimmune disease is a contraindication for mesh implantation according to some mesh manufacturer’s instructions for physicians (13). That contraindication warning for surgeons makes me wonder what manufacturers really knew about the connection between FBR and autoimmunity and implant failure or success and failed to share with physicians and surgeons.

#2 Foreign Body Response

The second ingredient for a harmful systemic storm is a combination of the short term acute inflammation of FBR that usually decreases after thirty days from when the mesh is implanted, preceded by decreasing low grade chronic inflammation thereafter. (2) However decreasing FBR is not always the outcome. Women with synthetic mesh implant complications have learned the hard way, that for women with mesh complications and implant failure, FBR does not decrease but increases, causing distressing cycles of burning sensation and pelvic cramping pain that many women say exceeds the pain of child birth and never ends. According to an article by a cancer treatment centre (3) “inflammation can become chronic if the cause of the inflammation persists, or because of deregulation in the control mechanisms responsible for shutting down the inflammation process.” Cancer researchers know there are links between chronic inflammation and cancer development (17, 18 ). Autoimmune researchers know there are links between autoimmune disease development and chronic inflammation (23 ). Some surgeons know there is a link between implants and autoimmune disease development (14).

# 3 Chronic Infection

Now the 3rd ingredient is a hit and miss in this recipe . It is like an optional ingredient you would never want .That ingredient is chronic infection. Many patients with mesh complications have chronic infections, infections safely hidden in mesh structures too small for “good guy” cells to go in and attack bacterial infection.

Prof. Garth L. Nicolson states in his article Autoimmune Illnesses and Degenerative Diseases, “chronic infections play an important role in autoimmune and degenerative disease, along with genetic predisposition and immune dysfunction (22).” Nicolson also states infection could be the cause of autoimmune disease or a cofactor.

Reading the study, Localized Immunosuppressive Environment in the Foreign Body Response to Implanted Biomaterials by David M. Higgins,* Randall J. Basaraba,* April C. Hohnbaum,* Eric J. Lee,* David W. Grainger,† and Mercedes Gonzalez-Juarrero , you become more aware of the serious harm of chronic infection and implant failure. According to these researchers “It is estimated that at least 20 million people in the United States have a biomaterial device implant. Implant device failure or implant-associated infections can have disastrous consequences for the implant device function and the host. Although the risk of implant-associated infections is small (1 to 7%), these infections are associated with considerable morbidity, expensive health care, and prolonged antibiotic therapy.2 The medical and surgical cost of treating certain device failures or implant-associated infections can average up to $50,000 per patient.3,4 These significant burdens and the increasing use of biomaterial implants in a myriad of medical applications warrants a clear understanding of the immune response to these materials (15 ) .”

So now we have recognized the following ingredients for a health disaster.

#1) hypersensitivity undiagnosed

#2) chronic inflammation causing degradation of mesh

#3) chronic infection.

#4 Chemical insults

Now let’s add the 4^th ingredient to the systemic storm recipe. Let’s add chemical irritation and insult. One product of the body’s attempt to break down polypropylene via peroxide (hydrogen peroxide produced by the body) is the dangerous Hydroxyl radical. Life Extension Magazine published a report in 1995 on the Hydroxyl radical. It was stated “the uncontrolled action of hydroxyl radicals the most damaging free radical by far can have devastating effects with the body.” Consequences of hydroxyl can be seen in many diseases such as atherosclerosis, cancer and neurological disorders (4). To add to the evidence that degradation of polypropylene releases damaging hydroxyls note the quote from S. A. M. Ali, P. J. Doherty, D. F. Williams*Article first published online: 10 MAR 2003. “Degradation is an essential factor in polymer biocompatibility. The physiological environment of the human body can be aggressive to polymers. Most implanted polymers suffer degradation and the kinetics and mechanisms of the processes can be significantly affected by various biologically active species, especially enzymes, lipids, peroxides, free radicals, and phagocytic cells. Iron enhances the toxicity of oxygen free radicals. Superoxide and hydrogen peroxide can interact to form the very toxic hydroxyl radical in the presence of iron. The data have shown that the hydroxyl radical is likely to be one of the main causes of polymer degradation in implantable devices. “

I could go on and on about the damage of free radicals but the point again is once again about inflammation; inflammation increased by chemical irritation. Inflammation is heightened by the reaction of damaged tissues surrounding the implant, tissues subjected to the peroxide attack against the implant material. Inflammation, chronic inflammation, has long been recognized as being a cause of diabetes, a cause of heart disease and a symptom of autoimmune disease. Perhaps more research should be done to address the fact that inflammation may not only be a symptom of autoimmune diseases but in fact be the cause of an autoimmune disease.

Lupus is one of the very scary autoimmune diseases some women are being diagnosed with after mesh implantation, after suffering months if not years of chronic pelvic inflammation from FBR to synthetic mesh. Many other autoimmune diseases are being diagnosed and suspected in this cohort of women, and in the population of hernia patents experiencing chronic FBR. Read the following abstract regarding Lupus by Zafar Rasheed, , Rizwan Ahmad, Naila Rasheed and Rashid Ali (2007)

“Systemic lupus erythematosus (SLE) is a chronic autoimmune disease with autoantibodies as a near universal feature of the disease. Earlier investigations from our laboratory revealed increased oxidative damage in SLE patients. Therefore, we hypothesized that oxidative by-products, such as hydroxyl radical (√OH), could lead to neoantigens like √OH damaged human serum albumin (HSA), which could in turn initiate autoimmunity in SLE (21).”

So back to the recipe,

So now we have,

#1) hypersensitivity undiagnosed

#2) chronic inflammation causing degradation of mesh

#3) chronic infections from mesh porosity size allowing bacteria a safe haven

#4) chemical insults, the degradation products of the oxidative process caused by FBR which are free radicals, the most worrisome being hydroxyl

Oxidative stress and damage

The recipe for a systemic storm is not complete yet. Consider a statement by Kurien BT, Hensley K, Bachmann M, Scofield RH. 2006 May 23.

“Free radical-mediated oxidative damage and consequent protein modification by the end products of oxidative damage are important mediators of cell toxicity and disease pathogenesis”.

(Free Radic Biol Med. 2006 Aug 15;41(4):549-56. Epub 2006 May 23.Oxidatively modified autoantigens in autoimmune diseases.

http://www.ncbi.nlm.nih.gov/pubmed/16863987?dopt=Abstract&holding=f1000,f1000m,isrctn)

We can now add oxidative damage or stress to the growing list of recipe ingredients for a damaging systemic storm. According to many research articles oxidative stress is implicated in autoimmunity onset, progression and exacerbation. (8, 9, 10,11 )For example, in the paper by MR Namazi, (http://www.jautoimdis.com/content/6/1/4 Cytochrome-P450 enzymes and autoimmunity: expansion of the relationship and introduction of free radicals as the link …..) we can read about the link between chronic oxidative stress and the evolution or trigger of autoimmune disease.

“ Hydroxyl radicals are also very highly reactive and could attack a wide range of targets. The presence of rheumatoid factors in some autoimmune diseases, such as vitiligo [9,11] and rheumatoid arthritis, can be explained by this mechanism. Over time, chronic oxidative stress could generate several adducted and/or non-adducted molecules that would essentially act as a “neo-antigens“. This is consistent with the slow maturation of auto-antibodies in the evolution of autoimmune diseases. During chronic oxidative stress, neo-antigens potentially cause tissue damage and release a plethora of sequestered auto-antigens. This process is referred to as the “bystander effect”. Such an outburst of auto-antigens from the target tissue would potentially amplify the effect of the neo-antigens, leading to the breakdown of self-tolerance [8].”

Furthermore , according to Dr. Ray D. Strand, MD,

“ There has been great interest among researchers for the past 20 years involving the role of oxidative stress in the development of arthritis. Most studies have not separated rheumatoid arthritis and osteoarthritis (degenerative arthritis) when looking at free radical reactions and these diseases. Information provided here is consistent with a comprehensive review article written by Dr. Henrotin in 1992 regarding oxidative stress and how it is involved in inflammatory joint disease. Several recent studies have further established oxidative stress as being the plausible cause of these diseases.

The immune system is intended to be our reliable protector. It is always checking for self (one’s own body) while it is looking for non-self (any foreign substance or abnormal cell). When the immune system finds a virus, bacteria, or foreign body it destroys and eliminates it from the body. However, in autoimmune diseases the immune system actually attacks itself rather than a foreign substance. If it attacks the joint space, a person is diagnosed as having rheumatoid arthritis. If it attacks the bowels, it manifests as Crohn’s disease or ulcerative colitis. When the connective tissue is attacked, a person might end up with scleraderma or lupus. If the myelin sheath around the nerve is the target, multiple sclerosis (MS) ensues. (www.raystrand.com/recommendations )”

Transobturator surgery

Note the statement that recent studies established oxidative stress as being the plausible cause of autoimmune diseases. Now who in their right mind would argue that mesh complication patients don’t have oxidative stress when enduring chronic painful FBR? So I will add oxidative stress to the recipe.

So now we have,

#1) hypersensitivity undiagnosed

#2) chronic inflammation causing degradation of mesh

#3) chronic infections from mesh porosity size allowing bacteria a safe haven

#4) chemical insults,degradation products of the oxidative process caused by FBR which are free radicals, the most worrisome being hydroxyl

#5) oxidative stress

When you look at that recipe and realize that chronic FBR goes undetected for long periods of time (sometimes years) in mesh complication patients, you may wonder why is it going undetected for so long? It appears that doctors are not looking for FBR symptoms! They don’t see what they do not recognize! Chronic FBR causes mesh degradation, causes systemic chain reactions, and causes autoimmune vulnerability. When delays in diagnosing mesh complications initiated by FBR happen, when misdiagnosing mesh complications as irritable bladder happen, it is like planting an autoimmune disease seed in a hot bed and then wondering why it grew so quickly and strong! The recipe ingredients outlined are all in mesh complication patients! Why are so many doctors seemingly oblivious to the obvious? My answer would be liability and accountability. The links are all there if one chooses to seek them…, one reaction sets off a chain reaction. So no surprise is among mesh victims sharing info about autoimmune issues after FBR to synthetic mesh. There is sadness, anger, and grief as many mesh complication victims not only learn to live with chronic pain but irreversible autoimmune diseases as well.

I believe future studies will prove that autoimmune diseases, are being diagnosed at higher rates in the population of women who have experienced extreme chronic FBR to synthetic mesh than those of the population with no synthetic implants or no known FBR to implants that have not degraded or caused adverse events. I believe this statement would hold true for our male counterparts with hernia mesh complications. Research needs to be focused on the systemic effects of FBR induced mesh complications. Doctors, especially primary care givers need to be educated to know the signs of FBR in their mesh implanted patients, and understand the progression from FBR to implant failure to autoimmune disease. Mesh complications are complicated! It is not just about pain, erosion, extrusion, infection, organ perforation, the inability to sit, to have sexual relationships. It really is about quality of life issues that are not reversible, that are a whole body injury from a less than perfect implant material. Systemic effects from mesh can kill slowly or quickly. Make no mistake, mesh can kill. Call it slow death by mesh if no doctor can remove your mesh implant or is willing to try when you are one of the not so rare patients experiencing chronic FBR, and in the eye of the perfect storm for a disaster. Am I being dramatic? Some doctors might think so. Patients with mesh complications would say no, no drama; it just is the way it is.

My survey of a group of patients with medical mesh complications results show that post implant surgery;

12% developed diabetes, or been diagnosed as pre-diabetic.

51% experienced Weight loss

3% developed asthma

20% reported exacerbation of pre-existing asthma

3% diagnosed with Lupus

12% developed rheumatoid arthritis

10% reported exacerbation of pre-existing arthritis

100% noticed a marked lack of energy post implantation, chronic fatigue

14% diagnosed with chronic fatigue syndrome

71 % have undiagnosed chronic fatigue symptoms

24% diagnosed with fibromyalgia

41% reported symptoms of fibromyalgia to be addressed or being addressed

63% reported blurred vision post mesh implant

44% reported having elevated fever, higher body temperature

39% reported lower body temperature

44% reported Hair loss, loss of facial and scalp hair

17% reported Hyperpigmentation, or dark tanning in skin

29% reported Painful skin rash,

25%    reported Fragile thin skin

36% reported Skin that bruises easily

24%    reported acne

24%    reported Skin rashes, especially “butterfly rash” on the nose and cheeks

41%   reported Sun sensitivity

46% reported dry eyes

44%    reported   dry mouth

51% reported extreme sensitivity to cold in the hands and feet

76%   reported   Recurring abdominal bloating and pain

39%    High blood pressure

90%   Irritability, anxiety and depression

92% reported ”Brain Fog,” difficulty concentrating,

53%     reported Lack of coordination or unsteady gait

61%   reported Dizziness, vertigo

58% reported Numbness, weakness, tingling or paralysis in one or more limbs

27% Tremors

25% Cysts on Ovaries

41% Increase in snoring

63% Shortness of breath and tightness in the chest

22% Unexplained anemia (low count of red blood cells

8% diagnosed with a connective tissue disorder post mesh

2% have you been diagnosed with cancer post mesh implantation

32% reported chemical sensitivities started post mesh implantation

41 % reported food sensitivities started post mesh

What could these symptoms indicate ? What are these symptoms associated with? You guessed it ….autoimmune diseases! Clearly we need research and scrutiny into the progression from foreign body response from synthetic mesh to autoimmune diseases development. Clearly if one researches one can see the dots connect! I suspect those who have the most to lose will not look, research or admit to causing autoimmune problems by using noninert mesh in highly susceptible patients. And here is a big question … if mesh becomes non-inert in 33% of the people it is implanted into, is the mesh defective? Clearly mesh degrades. Is that not a defect? It is designed to be permanently implanted so one would not find it a stable product if 33% of the meshes implanted degrade and the implants fail. This is a Pandora’s box. Who is brave enough to take on the manufacturers ? Is the ultimate liability so scarey the judicial system will avoid finding the product defective but give higher punitive awards for failure to warn? Well that question is food for more thought, to add to what I have already tried to piece together for a clearer picture of why implant rejection and failure is more than just a localized wound, but the starting point for a host of autoimmune systemic problems going unrecognized, unresearched, and untreated.

Mesh strands from Wideman urine

References

1) http://www.pqri.org/workshops/leach_ext/imagespdfs/posters/Polymer_Additives_PQRI_Poster.pdf

2) Long-term foreign-body reaction to preperitoneal polypropylene mesh in the pig, G. L. Beets, H. van Mameren, P. M. N. Y. H. Go

http://link.springer.com/article/10.1007/BF01569134

3)http://www.envita.com/cancer/chronic-inflammation-fuels-development-of-stage-cancer/

4) Oxidative Medicine and Cellular Longevity Volume 2011 (2011), Article ID 809696, 9 pages doi:10.1155/2011/809696 Review Article Hydroxyl Radical and Its Scavengers in Health and Disease,Boguslaw Lipinski, Joslin Diabetes Center, Harvard Medical School, Boston, MA 02215, USA Received 30 March 2011; Accepted 7 June 2011 Academic Editor: Kennet Maiese http://www.hindawi.com/journals/oximed/2011/809696/

5) Systemic effects of biomaterials Biomaterials ,Volume 5, Issue 1, January 1984,Pages http://www.sciencedirect.com/science/article/pii/0142961284900619

Jonathan Blac

University of Pennsylvania, Philadelphia, Pennsylvania, USA

http://dx.doi.org/10.1016/0142-9612(84)90061-9, How to Cite or Link Using

Abstract: Evaluation of the host response to implanted biomaterials usually focuses on the implant site tissue response. This may lead to erroneous conclusions in the same way that examination of battles outside of their historic context does. A broader view discloses a variety of possible and actual systemic effects of carcinogenic, metabolic, immunological and bacteriological nature. Recognition of these effects in patients is hampered by a lack of epidemiological studies.

Keywords

6) Autoimmunity. 2007 Nov;40(7):512-20.

Enhanced recognition of reactive oxygen species damaged human serum albumin by circulating systemic lupus erythematosus autoantibodies.

Sheikh Z, Ahmad R, Sheikh N, Ali R.,Source Department of Biochemistry, Faculty of Medicine, AMU, Aligarh, India. zrasheed@rediffmail.com http://www.ncbi.nlm.nih.gov/pubmed/17966041

7) The mechanisms of oxidative degradation of biomedical polymers by free radicals

http://onlinelibrary.wiley.com/doi/10.1002/app.1994.070510805/abstract

S. A. M. Ali, P. J. Doherty, D. F. Williams*

Article first published online: 10 MAR 2003

DOI: 10.1002/app.1994.070510805

Abstract

Degradation is an essential factor in polymer biocompatibility. The physiological environment of the human body can be aggressive to polymers. Most implanted polymers suffer degradation and the kinetics and mechanisms of the processes can be significantly affected by various biologically active species, especially enzymes, lipids, peroxides, free radicals, and phagocytic cells. Iron enhances the toxicity of oxygen free radicals. Superoxide and hydrogen peroxide can interact to form the very toxic hydroxyl radical in the presence of iron. The data have shown that the hydroxyl radical is likely to be one of the main causes of polymer degradation in implantable devices. © 1994 John Wiley & Sons, Inc.

8) http://europepmc.org/abstract/MED/12799017

“Increasing evidence shows that oxidative stress plays an important role in the pathogenesis of multiple sclerosis (MS) and its animal model, experimental autoimmune encephalomyelitis (EAE).”

9) http://www.ncbi.nlm.nih.gov/pubmed/22291449

Oxidative stress promotes hypertension and albuminuria during the autoimmune disease systemic lupus erythematosus.

10) Source http://www.ncbi.nlm.nih.gov/pubmed/22291449

Mathis KW, Venegas-Pont M, Masterson CW, Stewart NJ, Wasson KL, Ryan MJ.Department of Physiology and Biophysics, University of Mississippi Medical Center, Jackson, MS 39216-4505, USA.

Abstract: Several lines of evidence suggest that essential hypertension originates from an autoimmune-mediated mechanism. One consequence of chronic immune activation is the generation of oxygen-derived free radicals, resulting in oxidative stress.

11) http://www.ncbi.nlm.nih.gov/pubmed/16863987?dopt=Abstract&holding=f1000,f1000m,isrctn

Kurien BT, Hensley K, Bachmann M, Scofield RH.

Source :Free Radic Biol Med. 2006 Aug 15;41(4):549-56. Epub 2006 May 23.

Oxidatively modified autoantigens in autoimmune diseases. Arthritis and Immunology Program, Oklahoma Medical Research Foundation, Oklahoma City, Oklahoma, OK 73104, USA.

AbstractFree radical-mediated oxidative damage and consequent protein modification by the end products of oxidative damage are important mediators of cell toxicity and disease pathogenesis. Aldehydic products, mainly the 4-hydroxy-2-alkenals, form adducts with proteins and make them highly immunogenic. Oxidative modification of proteins has been shown to elicit antibodies in a variety of diseases including systemic lupus erythematosus (SLE), alcoholic liver disease, diabetes mellitus (DM), and rheumatoid arthritis (RA). Oxidatively modified DNA (8-oxodeoxyguanine) and low-density lipoproteins (LDL) occur in SLE, a disease in which premature atherosclerosis is a serious problem

12)http://journals.lww.com/greenjournal/Abstract/2010/10000/Polypropylene_Vaginal_Mesh_Grafts_in_Gynecology.24.aspx Polypropylene Vaginal Mesh Grafts in Gynecology,Ostergard, Donald R. MD,Obstetrics & Gynecology:

October 2010 – Volume 116 – Issue 4 – pp 962-966

“ Noninert polypropylene degrades into potentially toxic compounds that would be expected to stimulate a greater inflammatory reaction leading to erosion……….Manufacturers need encouragement to develop meshes that are inert and incorporate without contraction along with routine clinical tests to detect “high responders” to avoid complications. Polypropylene is not inert within the human body.”

13) http://www.lifebeatonline.com/procedure/ProcedureLanding.bsci/,,/navRelId/1000.1002/method/Procedure/id/10001031/attributeTypeId/1/resourceTypeId/91/seo.serve CONTRAINDICATIONS….Autoimmune connective tissue disease……

14) http://www.ehcd.com/Implant_Syndrome_070711.pdf

IMPLANT SYNDROME ,William J. Rea, M.D., F.A.C.S., F.A.A.E.M.

“The surgical use of artificial implants can induce both autoimmune disease and chemical sensitivity.”

15) http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2708803/)

16) http://link.springer.com/article/10.1007%2Fs00192-012-1678-2?LI=true

A standardized description of graft-containing meshes and recommended steps before the introduction of medical devices for prolapse surgery

Mark Slack, Donald Ostergard, Mauro Cervigni, Jan Deprest,International Urogynecology Journal,April 2012, Volume 23, Issue 1 Supplement, pp 15-26

Abstract: Over the past decade, a huge number of new implants and ancillary devices have been introduced to the market. Most of these have become clinically available with little or no clinical data or research. This is a less-than-ideal situation, and this subgroup of the ad hoc IUGA roundtable conference wants to open the discussion to change this, by proposing a pragmatic minimum clearance track for new products being introduced to the market. It consists of an accurate and more standardized product description, data on the biological properties gathered in animal experiments, anatomical cadaveric studies, and upfront clinical studies followed by a compulsory registry on the first 1,000 patients implanted. Ideally, manufacturers should support well-designed prospective (randomized) clinical trials that can support the claimed benefits of the new product. Data were presented at the 2nd IUGA Grafts Roundtable June 2010.

17) http://clinicaltrials.gov/ct2/show/NCT01428167?term=chronic+inflammation&rank=85 Hashimotos Thyroiditis and Thyroid Cancer

Sponsor:The University of Texas, Galveston Information provided by (Responsible Party):The University of Texas, Galveston ,ClinicalTrials.gov Identifier:NCT01428167,First received: August 10, 2011 Last updated: June 5,

Thyroid cancer (TC) is the most common endocrine malignancy. The association between inflammation and cancer is well established.

18) http://www.envita.com/cancer/chronic-inflammation-fuels-development-of-stage-cancer/

Inflammation can become chronic if the cause of the inflammation persists, or because of deregulation in the control mechanisms responsible for shutting down the inflammation process. When these inflammatory responses become chronic, cell mutation and proliferation can result and often create an environment that is conducive to the development of cancer.

Inflammation is the body’s response to tissue damage, caused by physical injury, ischemic injury (caused by an insufficient supply of blood to an organ), infection, exposure to toxins, or other types of trauma. The body’s inflammatory response causes cellular changes and immune responses that result in repair of the damaged tissue and cellular proliferation at the site of the injured tissue. Inflammation can become chronic if the cause of the inflammation persists, or because of deregulation in the control mechanisms responsible for shutting down the inflammation process. When these inflammatory responses become chronic, cell mutation and proliferation can result and often create an environment that is conducive to the development of cancer. This is often referred to as “the perfect storm.”

19) http://www.sciencedirect.com/science/article/pii/0142961284900619

Jonathan Blac, Systemic effects of biomaterials, Biomaterials Volume 5, Issue 1, January 1984, Pages 11–18Biointeractions ’84 Materials/Interactions-Conference Systemic effects of biomaterialsUniversity of Pennsylvania, Philadelphia, Pennsylvania, USA

20) http://onlinelibrary.wiley.com/doi/10.1002/app.1994.070510805/abstract

The mechanisms of oxidative degradation of biomedical polymers by free radicals ,S. A. M. Ali, P. J. Doherty, D. F. Williams*,Article first published online: 10 MAR 2003 ,DOI: 10.1002/app.1994.070510805

21) http://informahealthcare.com/doi/abs/10.1080/08916930701574331

2007, Vol. 40, No. 7 , Pages 512-520 (doi:10.1080/08916930701574331)

HTML PDF (213 KB) PDF Plus (217 KB) Department of Biochemistry, Faculty of Medicine, AMU, Aligarh, 202002, IndiaDepartment of Biochemistry, SBSPGI, Balawala, Dehradun, 248161, IndiaDivision of Pharmacology, Central Drug Research Institute, P.B. No. 173, Lucknow, Indi

22) (http://www.immed.org/illness/autoimmune_illness_research.html

23) http://onlinelibrary.wiley.com/doi/10.1046/j.1365-2249.2003.02104.x/full

H Ahsan, A Ali, R Ali – Clinical & Experimental Immunology, 2003 – Wiley Online

Summary: Reactive oxygen species generated during various metabolic and biochemical reactions have multifarious effects that include oxidative damage to DNA leading to various human degenerative and autoimmune diseases. #

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Suffering in Silence: Thousands of Canadian Women and Cherie Storozinski

Jane Akre — Sat, 04 May 2013 03:41:57 +0000

Cherie Storozinski

May 3, 2013~ “My name is Cherie Storozinski. I am 50 years old and live in Dauphin, Manitoba, Canada. I am a victim of transvagnial mesh.”

That’s how Cherie started her email to MDND.

Cherie, 50, had a wonderful life in rural Manitoba, Canada. She and her husband, Curt, live on 20 acres and run a micro-farm, nine miles outside of the small town with a population of 8,000.

She and her friends – the Crazy Cat Ladies Rural Rescue and Resource – started a cat rescue and spay program for feral barn cats. She has two large dogs and six cats, free-range chickens and she grows and cans food she and her husband eat. Of her three adult children, two work in Alberta and a third is studying mechanical engineering at the University of Manitoba. She worked as a licensed real estate agent/office administrator but works now as a part-time manager at a fitness center.

Cherie and bagpipes

Cherie began playing the bagpipes about 10 years ago. She hasn’t played the bagpipes in years, ever since her surgical mesh and uterine ablation procedures.

Cherie Storozinski’s story began in January 2010. After years of having issues with heavy periods she was referred to a gynecologist in Yorkton, Saskatchewan.

She didn’t have pelvic organ prolapse (POP) or stress urinary incontinence (SUI), other than when she laughed or played the bagpipes too hard, but the doctor thought her heavy periods could be treated with a uterine ablation. In that procedure the uterine wall is burned to stop or slows excessive menstrual bleeding.

During a September 2010 doctor’s appointment her surgeon suggested she might also be a candidate for a synthetic tape to treat her incontinence and he’d perform a test.

The sling, she was told, was a “piece of tape” that would lift up the urethra.

The Johnson & Johnson brochure says the Gynecare TVT Obturator System is a blue polypropylene Prolene mesh strip packaged with trocars (steel guides) to hold up the urethra, but Cherie says she never saw a brochure or any printed material.

The uterine ablation procedure was done in November 2010. Five months later in April 2011, with an IV delivering anesthesia, Cherie was on the table for the incontinence test.

“They tell you to fill the bladder with water then say you have to tell me when you can’t hold it anymore. I started leaking and told him I couldn’t hold it anymore then he makes you cough.”

The test showed she qualified and before she knew it, the anesthesia kicked in and the Saskatchewan gynecologist began implanting the synthetic mesh.

She observed there were at least four or five women prepped for surgery. She says he was “churning them out,” that day from the Saskatchewan operating room. Following her 20 minute procedure, she and her husband drove three hours to their home so she could recover.

At this time, Cherie was unaware that Health Canada, Canada’s version of the U.S. Food and Drug Administration (FDA), had issued a Notice to Hospitals on February 4, 2010. It encouraged that patients be informed before surgery of all adverse events including the “possible need for additional surgical procedures that may not always fully correct some potential complications.”

Cherie found the Health Canada warning after her surgery and says she was not told about the warning.

Afterward, when she woke and asked about the pain in her groin area Cherie was told it was due to the way her legs were in the stirrups during surgery.

“They said they didn’t put needles through. I even looked when I got home. I did not believe them, it was a 12-minute surgery. No way should my groin hurt like that.”

Other than the leg pain she had no problems until February 2012.

Cheri and family

“I started to experience discomfort and pain. I had cramping and a backache or a little leak here or there. I thought it was the bladder sling and called the doctor’s office in Yorkton only to be told I needed another referral.”

Her doctor treated her for a vaginal infection but the pain on the left side continued. She describes it as a burning or pinch and stabbing pain to the groin area. Cherie thought it was the mesh but her family doctor thought she had post-uterine ablation syndrome. Later the same doctor would tell her she never had a patient with complications from mesh.

An April 2012 ultrasound confirmed a cyst on the left ovary and fluid in the cervix, a symptom of a complication of post-uterine ablation syndrome.

The radiologist said that procedure should not be causing her pain but because of the symptoms she was scheduled for a complete hysterectomy in September 2012. Until then she still had the pain to deal with. Cherie’s husband had to take her to the emergency room in June for a pain shot.

Meanwhile the urinary leakage continued and Cherie suspected the sling was no longer working. First things first and the hysterectomy was performed removing her uterus.

“But in December I didn’t feel well one weekend. I stood up and I actually felt something move in my lower abdomen. A few days later my husband and I tried to have intercourse. I felt a lot of pain. I told my doctor I felt something moved and that there was pain. She told me things move after surgery and treated me for a bladder infection which turned out to be negative.”

The Rural Life

Knowing something was not right Cherie began a series of medical appointments. First she was treated for a bladder infection in January. In February she received a confirmation that the mesh had eroded through the vaginal wall and was now partially sticking out.

Each appointment represented a major hassle. The Storozinski’s rural home is at least two hours away from each doctors appointment. When Cherie began having pain she was asked to quit her job as a licensed real estate office administrator because, as she says she was told, “You don’t look happy and that’s now the image we want to portray here.”

This past February, Cherie drove another two hours to see a different urologist who did a cystoscopy and found there were no perforations in the bladder. He thought he could remove the TVT sling in his office and seemed surprised when she said ‘No’ because even the exam hurt too much, so much that she says she felt nauseous from the pain.

Under the Canadian system of healthcare, she was told it could be a six-month wait to have her surgeon/urologist remove the TVT sling. But she didn’t want to return to the same doctor who could only promise a partial mesh removal.

“I told my husband I don’t want to go back to him but he’s my only choice.”

“So then I started my journey of research. I sat for hours on the internet looking for information and doctors to help me with this issue. That is also how I discovered Canadian doctors will not remove all the mesh, just the piece that is bothering you the most. Canadian doctors also do not tell women should be going to the USA for total removal.”

April 30th in Manitoba

Media Coverage and Government Response

Early in 2013, Cherie saw a story in the Winnipeg Free Press about another woman plagued with complications following a mesh implant. See the story here.

Christine Asprey is a mother of four children who is part of a vocal band trying to raise awareness and funds to travel to Los Angeles for mesh removal from UCLA and the urology group headed by Dr. Shlomo Raz who appears to be having the most success globally with a full mesh removal. Using an imaging device, called a translabial ultrasound, Dr. Raz and his team can see the mesh before a removal which is thought to offer a surgeon the best chance to retrieve all of the polypropylene in what is otherwise essentially a blind procedure.

But it’s not cheap. The average cost is $30,000 and generally more than one visit to Los Angeles is required. Many times there is follow up reconstructive surgery needed.

One doctor from British Columbia told MDND that the same procedure in Canada only costs $500 but his province is not set up to take care of complications, just routine care.

Convinced there are no options in Canada, except partial removals, Stephanie Brad, Marika English and Ruth Olsen, three mesh-injured women from Saskatchewan, called the media as they appeared before their Minister of Health to say there are no Canadian doctors willing to do complete mesh removals. Partial removals had left many women in worse shape. See back story here.

The women were lobbying the provincial government to cover the estimated cost of travel to and from Los Angeles to have a mesh removal surgery not available in Canada.

Cheri’s husband walks the dogs

In response, the president of the Canadian Society of Pelvic Medicine sent Cherie a link to the Canadian “List” of doctors who can help with mesh complications. See the list here.

“To us, the injured patients, “seem to be able” is not good enough. Before trusting any surgeon again, we insist on evidence that the said specialists are able to do the procedure safely, without causing further damage,” was the response from the women.

“The list of doctors, I think it’s a knee jerk reaction to make themselves look good,” Cherie says acknowledging there were three women in Manitoba who had their mesh partially removed. “All three live in constant pain, all three of them.”

The women respond they are unwilling to risk further injury without proven successful outcomes.

To go outside of a province for medical services the patient has to have a recommendation from a specialist confirming the necessary medical service is not available there.

Media Coverage

In February, CTV- Television in Toronto did a follow-up to their successful series reporting on Canadian women demanding some answers from their government. (here)

“This whole thing is beyond frustrating. I feel so cheated by our medical profession and by our government. They allowed these meshed to be put in but will not send us to the professionals to remove the mesh and correct the damage the mesh has done. I ask myself why? Why because they would have to admit they are not capable, because they all have used that mesh and benefited from it? The fact that the mesh used in me was pulled off the market seems to make no difference. Sad. free medical is not what some people think. “

Under the Canadian health system, in order to obtain a referral out of the country you first must prove your exhausted all resources domestically. Cherie sought out and found a specialist, a urogynecologist in Manitoba, had a urodynamics test and he too offered a partial removal, but by now she’d been told that could allow pieces of mesh to migrate in her body. There was a risk of permanent nerve damage.

Sensing there was no trust between them, the doctor gave her what she had requested – a referral out of the country. She has a mesh removal surgery planned with a doctor in St. Louis who says he has been doing full mesh removal surgeries since 1996.

Cheri’s patio

Meanwhile the pain in her groin has gotten worse and she’s been back and forth to the hospital clinic for a heavy dose of antibiotics (2,500mg/day) to treat an infection at the site where the mesh has eroded into her vagina. There she received 2,500 mg of antibiotics a day.

Cherie’s referral may have opened to door to other women in Manitoba to be referred outside of Canada to surgery. But if she doesn’t get funded Cherie says she has no choice but to go anyway.

“My favourite place is my patio. I have a large pond with a waterfall. In the summer, weather permitting, I have my morning coffee on my patio. It is so peaceful, the birds land on the waterfall for a drink, you hear the other birds singing and the morning sun warms you up. I only hope that I can get this mesh out of me to fix up the flower beds around my patio. Last summer it was too painful to bend over and weed.”

Her law firm, Siskinds in Ontario (here) is currently representing about 1,000 mesh-injured women and their families.

Learn More:

CTV- Multimillion Dollar Lawsuit Filed Over Transvaginal Mesh, April 2012
http://www.ctv.ca/CTVNews/TopStories/20120417/transvaginal-mesh-women-lawsuit-incontinence-120417/

Health Canada warning, February 4, 2010
http://hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/_2010/surgical-mesh_nth-aah-eng.php
“Health Canada is concerned about Canadian and international reports of various intraoperative and postoperative complications associated with the use of these medical devices.”

Canadian News Wire on Transvaginal Mesh Class Action, April 17, 2012
http://www.newswire.ca/en/story/956349/transvaginal-mesh-class-action-commenced-in-canada

Mesh Medical Device News Desk – CTV Canadian Transvaginal Mesh Class Action Lawsuit, April 2012
http://meshmedicaldevicenewsdesk.com/latest-in-the-litigation-concerning-mesh-and-medical-devices/ctv-canadian-transvaginal-mesh-class-action-lawsuit/

Facebook Canadian Victims of Transvaginal Mesh
https://www.facebook.com/tvmcanada

MDND- Canadian Women Seek Transvaginal Mesh Removal Help in the US
http://meshmedicaldevicenewsdesk.com/media-reports/canadian-women-seek-transvaginal-mesh-removal-help-in-the-u-s/

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