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Suffering in Silence From A Medical Device - Surgical Mesh (Part 2)

Posted by Jane Akre
Wednesday, April 08, 2009 12:31 AM EST
Category: Major Medical, Protecting Your Family
Tags: Synthetic Surgical Mesh, Urinary Incontinence, FDA, Hernia, Ethicon, Medical Devices, Kugel, ProteGen, Boston Scientific, Johnson & Johnson, Pelvic Organ Prolapse, Federal Preemption, Riegel, Medtronics

Synthetic surgical mesh can cause problems and is not regulated by the FDA.

Part 2 - Suffering in Silence from a Medical Device - Surgical Mesh 

LEARN MORE

Suzanne McClain speaking out about surgical mesh for urinary incontinence.
Suzanne McClain

 

IMAGE SOURCE:  Surgical mesh, Nylon 66 top left, IVS top right, Soarc bottom left, TVT bottom right/ Int. Urogynecol. J. 2003, Web image 

 

IMAGE SOURCE:  (inset) Courtesy: Suzanne McClain

Background :  As we reported in Part One of “Suffering in Silence” – Suzanne McClain had what she was told by her doctor would be a routine, simple surgery to correct stress urinary incontinence (SUI) experienced by about 13 million American woman. The condition causes urine leakage during laughing or coughing.   

In 2008, a urogynecologist found the TVT mesh had invaded McClain’s vaginal wall, a side effect of the migrating synthetic mesh that an increasing number of women and men (for hernia repair) are experiencing. A surgeon was only able to extract about one-third of the mesh leaving behind the rest which had become enmeshed in her tissues.

An Angry Woman

Last year, when Suzanne McClain filed a complaint with the medical board against the surgeon who promised a safe and effective medical procedure to treat SUI without informing her of the side effects, his response in writing was that she was an “angry woman.”

Suzanne tells IB News she is still angry.  

“I feel like I was used as a guinea pig and that my doctor, the manufacturer, and the FDA are all responsible; my doctor for non disclosure of possible complications, the manufacturer for allowing this device to remain on the market to harm other women despite the fact that numerous adverse events that are on file and continue to be reported to the FDA.” 

And what makes her and others angrier is that the mesh embedded in their bodies never went through the premarket approval (PMA) process for safety most people assume has been conducted by the federal Food and Drug Administration, especially for a medical device to be implanted internally. 

“Until hearing Suzanne's story, I did not know that products could be placed on the market without proper testing. I just assumed that all products that are FDA approved were tested. Bad assumption obviously” says Naomi writing to Part One of the story.  

Proof of Safety and Efficacy May Not Be Required

The past president of the American Urogynecologic Society (AUGS), Dr. Donald Ostergard, delivered the keynote address to the annual meeting of AUGS in Palm Springs, California, October 2006.

Approval for new surgical implants such as mesh is different than those for a new medication he told the crowd.  The proof of safety and efficacy may not be required. 

510(k)

It’s a little known loophole buried deep within the administrative jargon of the Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) which is responsible for overseeing medical devices.

The process is known as – 510(k) – and is designed to fast-track the marketing of low risk medical devices that fall under a Class I category such as latex gloves, wheelchairs, and tongue depressors, or Class II devices, such as a urological catheter, non-invasive blood glucose monitors, and surgical mesh.

The manufacturer of a Class I or II medical device provides a letter to convince the CDRH that the device is “substantially equivalent” to a legally marketed device already on the market known as a “predicate device”.  

The application can be done quickly and through the mail, as seen in a letter in 2005 from the FDA to Gynecare concerning the TVT SECUR sling,  “The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.”  (italics by IB). 

Essentially it's an approval for marketing, not an approval based on safety – that’s optional. 

The FDA’s Bill Sutton, who directs the division of small manufacturers, tells IB News, “If the company provided a summary of safety and effectiveness that is the manufacturer's choice.”   

“It’s very rare we rescind a 510(k)” says Sutton, referring to an option the FDA has to prohibit the manufacturer from marketing the 510(k) device.  A voluntary recall can also be conducted, but that is at the company’s discretion.  

With 3,600 510(k) applications a year, Sutton says, “Maybe two percent or one percent are not found to be substantially equivalent. Well over 90 percent are cleared by the 510(k) process.” 


What Happens When The Predicate Device Is Withdrawn? 

The history of urinary incontinence or pelvic organ prolapse mesh reads like a laundry list of “substantially equivalent”  “predicate devices”. 

In the early 1990s, the Vesica procedure was introduced to treat stress urinary incontinence (SUI).   Vesica was a watershed event largely because the tape was delivered precut in a “surgical kit” marketed to doctors to turn synthetic surgical repair mesh into a billion dollar business.      

The ProteGen sling (coated with bovine collagen) was approved in 1996 when device maker Boston Scientific claimed that ProteGen was “substantially equivalent” to the Vesica, which was now largely abandoned.

Suzanne was treated with Ethicon’s (Johnson & Johnson) Transvaginal (Tension-Free) Surgical mesh, which was predicated on the Boston Scientific ProteGen Sling.   

Yet in March 1999, 14 months after the Ethicon TVT tape was approved, its predicate device – the ProteGen sling - was recalled from the market. The FDA said the ProteGen Sling was “adulterated and misbranded” and leading to problems such as vaginal erosion or dehiscence and did not appear to function as intended.

At least 1 class action lawsuit resulted charging device maker Boston Scientific with defective design, failure to warn, negligent training of physicians, fraudulent concealment, Fraud on the FDA, misrepresentation, and breach of warranty among other claims.

“It defies logic,” says Suzanne McClain in a letter to InjuryBoard, “Common sense should have dictated that all devices that had received approval using the ProteGen Sling as their predicate device would too have been pulled from the market.”

“It’s not a regulatory requirement to do so” says Siobhan DeLancey, press officer for the Center for Devices and Radiological Health (CDRH) to IB News.  “We have an informal policy, if the predicate was withdrawn because of manufacturing, not specifications itself, then we may not look at 510(k) device. It’s kind of a case by case basis.”  


Industry Acknowledges The Problem

Writing in OBG Management, March 2009, Dr. Anne Weber who sees the Ethicon TVT mesh as an improvement upon the other meshes, is concerned about the assumption of safety.  

“Nevertheless, I am concerned that some clinicians do not appear to appreciate the true lack of evidence that accompanies most marketed devices for prolapse and incontinence. They may mistake the FDA 510(k) process of clearance for something similar to the agency’s extended and complex drug approval process. They may accept claims made in industry-produced white papers that are often largely promotional materials, and fail to look further into those claims.”

“Since these products are being widely used and successfully marketed with scant published data, there is very little commercial incentive to publish results,” the American Urogynecological Society (AUGS) says in its review of its 27th Annual Scientific Meeting. 

Audience member Dr. Matt Barber noted: "We are chasing a moving target," noting that new products are introduced faster than they can be evaluated, then taken off the market, modified somewhat, then reintroduced.

For example, doctors looking for any medical literature on the ProteGen sling wouldn’t find any until after market withdrawal.  Surgeons using the ProteGen from 1997 to 1999 did so without any published scientific endorsements.

“Without adequate information, the possibility that associated problems will not be identified until a new device has been used on hundred or possibly thousands of women is significantly increased,” concludes the AUGS meeting.  

Estimates are that over 2,000 women receive some type of pelvic organ prolapse support implants each month, “despite a paucity of published safety and efficacy data” the organization admits.   

McClain is no longer suffering in silence. She and other members of the patient advocacy group, Truth In Medicine  are calling for Congressional hearings. 

“How many more women have to be harmed before the FDA does their job and issues a recall?" she asks.

(Continue reading: Suffering in Silence - Part 3- Doctors Weigh In On Surgical Mesh).  # 


32 Comments

Anonymous User
Posted by Suzanne McClain
Wednesday, April 08, 2009 2:04 AM EST

After finding out I had a problem with erosion, I started searching the internet. One of the very first sites I found in regards to TVT complications was a blog set up by Lana Keeton on August 12, 2007, and I was floored to read of the complications that women were suffering at the hands of this device, or “substantially equivalent” devices approved by the FDA.

To date, there are 801 comments, and forty of our fifty United States are represented, as well as five other Countries. Most of the posts are from women who have been irrevocably harmed by Transvaginal mesh, some from women who are/were contemplating the surgery and were seeking information, and your occasional “mole” as I like to call them, whom I strongly suspect work for Pharmaceutical companies, and who praise the product. Of course, harsh comments from women who have been harmed, myself included, squelch their rhetoric in a hurry.

The States and Countries represented in this blog are:

AL, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MO, MN, MS, MT, NC, ND, NM, NJ, NV, OH, OK, OR, PA, SC, SD, TN, TX, VA, VT, WA, WI, WV.

Australia
Canada
Korea
Portugal
UK

Here is the link to this blog. Please, randomly sample from the 801 comments, and you will have a better understanding of the horror these women are suffering.

LINK

This is a global problem, not just one in the United States. I very much want to help these women get proper care, and find justice as well. There are many, many women in Canada and the UK who have posted, more so than the other three foreign countries. The general consensus among them is that they are having trouble locating doctors who are qualified in the removal of this mesh, and like me, they say they were never told of the risks in the first place.

It seems the entire Medical System in these countries needs a complete overhaul, just as our Food and Drug Administration does.

For information on what action to take after you have been harmed, please read post numbers 680-690, where I have posted step by step how to obtain medical records and from whom, and how to file an accurate adverse event with the FDA on form #3500.

Anonymous User
Posted by teresa hughes
Wednesday, April 08, 2009 1:17 PM EST

hi! my name is teresa hughes from england.
i have had this operation which has caused me so many complications. i have now been approved an e mail petition on the website of number 10 downing street england the prime minister of englands residence. this petition is for people to sign up to so that investigations can take place about this barbaric operation. I need answers!
the website is petitions.number10.gov.uk/tvtslingmisery if you know of anyone in the united kingdom who would like to sign this petition please give them the address of the website.
regards teresa hughes

Posted by Lana Keeton
Wednesday, April 08, 2009 5:01 PM EST

Please visit www. truthinmedicine. us. com

Please register the complications you suffer from the implantation of Synthetic Surgical Mesh on the International Registry of Complications.

It meets all the requirements of the U.S. Food and Drug Administration in order to have Synthetic Surgical Mesh removed from the market here in the United States.

Truth in Medicine offers solutions to stop future harm from the implantation of Synthetic Surgical Mesh. We are in direct contact with members of Congress.

Our voice has been heard at the FDA. On October 21, 2008, the following Public Health Notification was issued primarily because of the relentless efforts of Jim Shull, a Director of Truth in Medicine.

Information on Surgical Mesh for Pelvic Organ Prolapse and Stress Urinary Incontinence

FDA wants to inform you about the complications that can occur when surgical mesh is used to treat Pelvic Organ Prolapse (POP) and Stress Urinary Incontinence (SUI), and provide you with questions to ask your surgeon before having these procedures. This is part of our commitment to keep healthcare professionals and the public informed about the medical products we regulate.

FDA has received reports of complications associated with the placement of mesh through an incision made in the wall of the vagina. Although rare, these complications can have serious consequences. The reports have not been linked to a single brand or model of mesh.

The most frequent complications included erosion through the vagina, infection, pain, urinary problems and recurrence of the prolapse and/or incontinence.

In some cases, erosion of the mesh and scarring of the vagina led to discomfort and pain, including pain during sexual intercourse. Some patients needed additional surgery to remove the mesh that had eroded into the vagina. Other complications included injuries to nearby organs such as the bowel and bladder, or blood vessels .

Background
A pelvic organ prolapse (POP) occurs when a pelvic organ, such as your bladder, drops (“prolapses”) from its normal position and pushes against the walls of your vagina. This can happen if the muscles that hold your pelvic organs in place become weak or stretched from childbirth or surgery. More than one pelvic organ can drop at the same time. Organs that can be involved in a pelvic organ prolapse include the bladder, the uterus, the bowel and the rectum.

Pelvic organ prolapse can cause pain or problems with bowel and bladder functions or interfere with sexual activity.

Stress urinary incontinence (SUI) is a type of incontinence caused by leakage of urine during moments of physical stress.

Talking to your doctor
Before having an operation for POP or SUI, be sure to let your surgeon know if you’ve had a past reaction to mesh materials such as polypropylene.

Questions you should ask the surgeon before you agree to surgery in which mesh will be used:
• What are the pros and cons of using surgical mesh in my particular case? Can my repair be successfully performed without using mesh?
• If a mesh is to be used, what’s been your experience with implanting this particular product? What experience have your other patients had with this product?
• What’s been your experience in dealing with the complications that might occur?
• What can I expect to feel after surgery and for how long?
• Are there any specific side effects I should let you know about after the surgery?
• What if the mesh doesn’t correct my problem?
• If I have a complication related to the mesh, can the mesh be removed and what could the consequences be?
• If a mesh is to be used, is there patient information that comes with the product, and can I have a copy?

Reporting complications to the FDA
In order to help FDA learn more about possible problems with surgical mesh, it is important that both physicians and patients report complications that may be associated with this product.
You can report any problems to the FDA's MedWatch Adverse Event Reporting program either online, by mail or FAX.

• Online : LINK

• Mail : use postage-paid FDA form 3500 available at: LINK
Mail to MedWatch 5600 Fishers Lane, Rockville, MD 20852-9787

• FAX: 1-800-FDA-0178

Related Links
• FDA Public Health Notification: Serious Complications Associated with Transvaginal Placement of Surgical Mesh in Repair of Pelvic Organ Prolapse and Stress Urinary Incontinence

• Information on Surgical Mesh for Hernia Repairs

Updated October 21, 2008


MUCH MORE HAS TO BE DONE…

HELP TRUTH IN MEDICINE TO STOP THE IMPLANTATION OF SYNTHETIC SURGICAL MESH IN HUMAN BEINGS….

GO TO > > www. truthinmedicine. us. com.

PLEASE REGISTER YOUR COMPLICATIONS TODAY. YOU CAN NOT CHANGE WHAT HAS HAPPENED TO YOU.

YOU CAN STOP IT FROM HAPPENING TO OTHERS!!!

GOD BLESS, LANA KEETON
FOUNDER, TRUTH IN MEDICINE
truthinmedicine@bellsouth.net
305-342-8002

Posted by Lana Keeton
Wednesday, April 08, 2009 7:10 PM EST

Just for the record....

“It’s a little known loophole buried deep within the administrative jargon of the Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) which is responsible for overseeing medical devices.”

It may be little known but it is not a loophole.

The 510 (k) Pre-Market Notification Approval Process (PMN) was created by the Medical Device Act of 1976…a law that was passed by Congress!!!

NO HUMAN CLINICAL TRIALS are necessary.

NO PROOF of SAFETY OR EFFICACY (THAT IT WORKS) is required.


“The manufacturer of a Class I or II medical device provides a letter to convince the CDRH that the device is ‘substantially equivalent’ to a legally marketed device already on the market known as a ‘predicate device’.”

No convincing is necessary. It is a matter of course.

A Medical Device Manufacturer sends in the application and the Center for Devices and Radiological Health (CDRH) approves it, normally in 1 to 3 months.

“Writing in OBG Management, March 2009, Dr. Anne Weber who sees the Ethicon TVT mesh as an improvement upon the other meshes, is concerned about the assumption of safety.”

No explanation is given by Dr. Weber as to why she sees the Ethicon TVT mesh as an improvement upon other meshes.

Where is the data to back up that statement?

There is no data anywhere to substantiate "the Ethicon TVT mesh as an improvement upon other meshes".

Not that I do not agree with a significant portion of the article "written" by Dr. Ann Weber, it is clearly a subtle advertisement for Ethicon written in the guise of support for patients.

I do not know the real source of this material. I have a high suspicion that this is written by an employee at Dowden Health Media and paid for by Ethicon/J&J.

Just my suspicion based on a tremendous amount of research over the last few years...

Wishing you pain free days and the ability to get your life back...

God bless you, Lana Keeton
Founder, Truth in Medicine
truthinmedicine@bellsouth.net
305-342-8002

Anonymous User
Posted by Krystil
Thursday, April 09, 2009 2:50 AM EST

Multiple red flags jump out after having read this article (part two).
First off, Class II devices include urological catheters, noninvasive blood glucose monitors and surgical mesh. Does anyone want to play which one doesn't belong? You don't even have to be in the medical field to pick this one out. Let's see: 1.urinary catheters are either used as an "in and out cath" put in to drain the bladder and then immediately removed, or as an indwelling temporary device usually in an ICU or post op setting. 2.Non invasive blood glucose monitors - need i say more than non invasive? 3.Last, but not least, surgical mesh. Only a genius would not be able to see that this permanent invasive device should be in a class all by itself.

The second red flag I noticed was this: It is at the companies discression wether or not to send a summary of safety and effectiveness of the device they are requesting approval from. I am truly at a loss for words on this being acceptable.

The third red flag: The original device that all other claim to be modeled after is not really in use anymore "all but abandoned", the second device which received approval based on the first has been pulled from the market because it did not "appear to function as intended", the third device, the one used in Suzanne, which was given FDA approval based upon it being a comprable to thepredicate device now pulled from the market REMAINS IN USE TODAY?
This seems a no brainer. Congress and the FDA need to take notice, stand up, and get a backbone. This approval law needs to be changed immediately, before more innocent people's lives are ruined.

Anonymous User
Posted by Chris
Thursday, April 09, 2009 2:56 AM EST

I am appalled that Suzanne's doctor would dare to call her an "angry woman" as if this were an unjustified response to the pain and suffering that she is going through, and in writing to top it off. I hope that Suzanne has filed a complaint against this physician with the medical board in her state. If even one person thinks to research this doctor and views this complaint before seeing him as a patient she will have made a huge difference in this persons life.

Anonymous User
Posted by MOM1965
Thursday, April 09, 2009 7:43 AM EST

Well if SUZANNE is an angry woman she has good reason,I am a angey woman as well.All this anger has been caused by the dreaded TVT mesh that we were blindly lead to believe that it would be so simply and so good .There are 1000s of suffers out there and most likely 100s added to the list every day...

Anonymous User
Posted by Toni
Thursday, April 09, 2009 9:41 AM EST

WOW!! Her Dr. had the nerve to call her an "angry woman?" After what he did to her, he should have been down on his knees begging for forgiveness! Its a shame that the medical profession doesnt take their role in saving people's lives more seriously. The fact that they don't test every product that goes inside a human body is astonishing! I personally work in a research lab, and the amount of testing that we do more extensive that what is being done with these medical devices! Congress really needs to step up and do what's right here...one day they will get in right.

Anonymous User
Posted by Becky
Thursday, April 09, 2009 10:20 AM EST

I believe that it is time for medicine in the US to be overhauled.

Too many people are suffering from a lack of attention paid to us by our physicians. Doctors are trusted individuals...they really should know better. Now, it seems, we have to know as much about medicine to be able to make sure our doctors are doing everything they can to the best of their abilities. Does this mean we all should be going to medical school? (I know...Doctors aren't 100% at fault as they have to see an increasing number of patients to survive financially b/c the insurance companies are drowning us all in costs.)

Enough of that sidetrack - Suzanne has every right to be angry. She was misled and poorly informed. J&J should, if they are smart, recall the product, remove it from the market and at least offer an apology to those who have suffered. And, if they are really smart, they should cover the costs of the followup doctor visits to have the problems from their devices corrected.

This looks like the FDA, the company (who really should know better and cover their butts and actually DO the research on products...costs the company WAY more to do what they are doing (or getting ready to do) to recall/remove the product and recover from the negative press than it does to DO the research in the first place), and the doctor all dropped the ball with this one. How about we wake up and smell the law suits, people...

I've not personally suffered from SUI, but my mom is starting to, and I'll be sure to pass this important information on to her. I have experienced medical negligence and thanks to my own education and the fact that my husband is in the medical field I've been protected from more serious complications.

Anonymous User
Posted by Mark
Thursday, April 09, 2009 11:19 AM EST

I understand why the doctor would think Suzanne was and is a "ANGRY WOMEN". She has the right to feel that way. I am her brother and the doctor could say I am a "ANGRY MEN" because I am. I am not only angry because this is my sister, but I am angry because this has happened to so many women and men and the harm is still going on everyday. Suzanne is a fighter, she is a caring person and she has always been there for people that need help. This fight is not just for her, but for all the people out there that has been harmed by this device. She needs your support by the way of comments, posts and opinions. People and companies do alot of things for money, but harming people for money is just wrong and it NEEDS to stop now. If Suzanne get her way it will. I want to thank Jane Akre for doing these stories. Without Jane people would have to Suffer In Silence. Thank You, Jane

Anonymous User
Posted by Janet
Thursday, April 09, 2009 12:07 PM EST

I have been reading all postings and have never heard of this. I have just reconnected with Suzanne recently. I had an abdominal hernia surgery Dec.1,2006 and had mesh implanted in my abdominal wall to keep my intestines from pushing thru the wall. I don't even know what kind of mesh was inserted in my body but am going to definately research. I don't really know where to start but wonder if I get my hospital records if it would have the mesh mfg. Are these the same as the bladder slings? I was told by the Surgeon that whenever that there was a risk of infection at the time of surgery but that there would be no residual problems...Suzanne I am so proud that you have stood up and made yourself heard!

Anonymous User
Posted by Jim Shull
Thursday, April 09, 2009 4:47 PM EST

This is not a female only nightmare. The use of Synthetic Surgical Mesh is also implanted in to men, for many types of hernias, it is also implanted into woman for the same types of hernias, the problem is that the FDA/CDRH have released the Public Health Notification for the Pelvic Prolapse and the Urinary Incontinence. The meshes used for these conditions are also of the same make and chemical make-up as those used in hernia repair, so the logic is, if one type is bad, why aren't the others bad, in the eye of the FDA/CDRH. I have been suffering from a mesh implant (Plug and Patch) for many years now. I have had the product removed, but, it took 2 more surgeries. I am still not out of the woods, as I still am living with chronic pain. I have had many nerve block injections in the groin and as of yesterday, I am now having the injections at the spinal level. If there are any men out there having complications from implantable mesh, you should stand up and be heard. The FDA is now at the point where they will not discuss what is happening with their so called investigation, if there ever was one. I have hundreds of correspondances from FDA/CDRH officials stating that they are investigating all of these products, along with letters from the director of the CDRH himself, stating that they are aware of the complications of these products, but yet, nothing is being done!! I continue to work as hard as I can to bring this horrible and tragic nightmare to the public eye, with a big emphasis as to why theses surgeons do not tell the patients of the real risks involved with the placement of implantable mesh. It is true, that none of these products were ever tested for safety in humans, so we continue to be their test subjects.

Anonymous User
Posted by Brad Siders
Thursday, April 09, 2009 8:52 PM EST

I've known Suzanne since she was a little girl growing up across the street from me in Phoenix,AZ it makes me sick to know that she's being put through this horrible ordeal and that her so-called Dr. would simply blow her off as an "Angry Woman" This man and the company that made this device should be held accountable for their actions!! Suzanne, I will keep you in my thoughts and prayers and I hope you get the justice that you deserve!

Anonymous User
Posted by Brad Siders
Thursday, April 09, 2009 8:52 PM EST

I've known Suzanne since she was a little girl growing up across the street from me in Phoenix,AZ it makes me sick to know that she's being put through this horrible ordeal and that her so-called Dr. would simply blow her off as an "Angry Woman" This man and the company that made this device should be held accountable for their actions!! Suzanne, I will keep you in my thoughts and prayers and I hope you get the justice that you deserve!

Anonymous User
Posted by Naomi
Thursday, April 09, 2009 11:17 PM EST

People are told this will be a routine procedure with a little discomfort. These people's lives are changed because these products are not tested prior to being placed on the market. How can we not test a product before it is placed in the human body? No one is ever told that the products that were used to approve the one being used in their body is either not being used in anymore or was pulled from the market...they are just given this option which sounds great because they are never given all the facts. After all, it's FDA approved. To most consumers, this means the FDA has done some testing and proven that it is safe.

I work in IT and we have to test our releases of our products and software prior to providing to our customers. It appears we do more testing with software than the government does with medical devices.

Anonymous User
Posted by Mary Bruffett
Friday, April 10, 2009 9:25 PM EST

Thank you Suzanne for getting this well written article out to the public. What a wonderful idea! If you can save ONE person from Mesh Hell, you are a HERO! Keep up the good work! Your Mesh-Sister just up I-44, Mary in MO

Anonymous User
Posted by Suzanne McClain
Saturday, April 11, 2009 1:27 AM EST

Mary,

I was successful in getting the attention of Ms. Jane Akre several months back, when I sent her my story on my complications, and material to back up the details that I gave her.

I cannot take credit for this well written article, that goes to Jane. Without her rallying on our behalf, and taking the time to verify all the research that I sent her, taking the time to find additional sources on her own, and interviewing all the people she has, our story would never have been told. She is an amazing woman and a wonderful author.

Thank you for your kind words, and please, spread the word about these articles. It gives others the venue to educate themselves not only on surgical mesh, but on how the FDA feels justified in leaving dangerous devices on the market to harm people.

I can understand a band-aid, a tongue depressor, gauze, medical adhesive tape, finger splits, all things used on the exterior of the body being approved under the 510K, but never should a device that is to be implanted in one's body be approved without clinical trials that prove the safety and efficacy of a product. The only time this practice should be allowed is when the patient signs up to be a part of a clinical study, and even then the possible risks and complications should be explained to them.

We are the non-consenting clinical trials!

Best ~ Suzanne

Anonymous User
Posted by JILL PAUL RN
Sunday, April 12, 2009 10:36 PM EST

Suzanne, there are so many of us out there who have suffered from some form of implanted medical device. My husband not only suffered 37 horrific, debilitating shocks from his fractured lead to his pacemaker/ICD, he is now complaining of right inguinal pain from his hernia repair with insertion of mesh in '07 - this complaint is very new. Trust me, he is very low key and not a "complainer". As an RN, I wonder what is going on with this new complaint after reading all of your articles. I am on a crusade to pass the Medical Device Safety Act now in Committee in Congress and The Senate. Thank you for signing the petition. The act called S540/HR1346 can be viewed on thomas.gov. I encourage each and everyone reading this to sign and make comments on the petition at:
LINK

I also encourage everyone to send an email to their respective Congressmen/Women and Senators to show their support and co-sponsorship of this very important bill to protect you, your Children, and Grandchildren so that they will not have to endure the pain and suffering that we have had to endure. By passing this bill, it will restore our legal rights as United States citizens and hold accountable those manufacturing companies who can now "hide" under FDA Preemption. We cannot do this alone for the Lobbyists are too powerful. We MUST stand together to make our voices heard. Please, join the petition and also write those emails to Congress and the Senate. Thank you.

Anonymous User
Posted by JILL PAUL RN
Sunday, April 12, 2009 10:52 PM EST

Sorry - I goofed. I've had a very long day at work and did a typo. The petition is:
LINK

THANKS FOR SIGNING FOLKS. WE NEED YOUR SUPPORT.

JILL

Anonymous User
Posted by Dana
Tuesday, April 14, 2009 4:23 PM EST

It is unreal that some doctors are using these medical devices without the device ever being tested first. If the FDA isn’t going to require that every medical device be tested then it is up to the doctors to refuse to use these products. Suzanne has suffered needlessly and she has every right to be angry!

Anonymous User
Posted by Donna
Thursday, April 16, 2009 2:06 PM EST

How can products and medical devices be cleared for general public use when they have not been thoroughly tested and proclaimed safe by the FDA? The Federal Drug Administration is our watchdog. Is it sleeping on the job? If it is, too many people are paying the price for its negligence.
Wake Up, FDA!

I'm angry, too!

Anonymous User
Posted by Dave
Thursday, April 16, 2009 3:00 PM EST

The TVT Mesh is not the equivalent of a harmless device, like a tongue depressor. The FDA should not allow Fast Track approval for anything internal. The fact that the device it was compared with was pulled from the market says something is terribly wrong. That the Mesh was allowed to be inserted defies all logic. Apparently the FDA only protects greed.

Anonymous User
Posted by Dana
Thursday, April 16, 2009 3:38 PM EST

Does the FDA have a certain number of people that have to be hurt by a medical device before they will stand up and do something? It is insane that the public has to go to these lengths to get something done. One injury should be one too many.

Anonymous User
Posted by Jessie
Thursday, April 16, 2009 4:37 PM EST

Suzanne: It's a shame that you have to be a "guinea pig" for this device and surgery. Logic (?)would dictate that sufficient testing be conducted to prove or disprove credibility of materials used during this type of surgery. The oversight of this testing has caused pain and suffering to far too many human beings who were just looking to have a better quality of life. The statement was made that this procedure would solve the problem. Well, it hasn't always performed to expectations and has, too often, created more problems that now have to be surgically repaired yet again. Such a waste and the insurance companies find something else to complain about and use as an excuse to raise premiums. Hopefully, when lawmakers hear it first-hand, regulations will become more stringent and enforced.

Anonymous User
Posted by Barbara
Thursday, April 16, 2009 8:08 PM EST

There is a committee in Washington DC for everything else - I think there should be a committee that doctors should have to answer to and this committee should decide if the doctors are liable for problems with devices and sugeries.

Doctors should do a study and be well educated with the pro and con of a device or surgery before
doing it.

Doctors should also have their license taken away if they have the bedside manners which was shown to Suzanne. No one wants to be told that they won the prize but not a good one for something as serious as this.

My husband had kidney stone surgery from this doctor and we were very blessed that he did not lose his kidney from this treatment.

I am thankful to have Suzanne for a friend as she is so concerned about other people that she would share her problems to prevent someone else the pain and suffering she has gone through.

Anonymous User
Posted by Carol
Thursday, April 16, 2009 9:02 PM EST

An "Angry Woman" has every right to be angry that she can not trust her doctor to improve her health and not ruin her health. This doctor is trying to place blame instead of taking responsibility. Suzanne, I am sorry for your pain and suffering and hope that you are successful in your quest to protect others and have the doctor and the FDA take responsibility.

Anonymous User
Posted by Julie T.
Friday, April 17, 2009 10:48 AM EST

Let me begin by saying that I know Suzanne personally and I have been a witness to the terrible physical and emotional pain this ordeal has caused her. I am completely shocked that the FDA, whom we should be able to TRUST, can allow this device to be used without pre-market approval. Absolutely unbelievable!! How many other medical devices, medicines, etc. are still out there that haven't been approved? The numbers are probably astronomical. Also, I can't believe that this synthetic mesh is classed as "non-invasive". This device is IMPLANTED in a person's body...seems pretty damned invasive to me. The FDA needs to wake up and start doing their jobs. Suzanne is a compassionate, strong-willed and determined lady and I wish her nothing but the BEST in her battle to speak up for her rights as well as others who have suffered through this terrible ordeal.

Anonymous User
Posted by GERI REINIGER
Tuesday, April 21, 2009 6:14 AM EST

SUZANNE-
FIRST OF ALL, I COMMEND YOU FOR THE COURAGE TO SHARE YOUR STORY WITH THE PUBLIC. YOU ARE AT LEAST OPENING A WINDOW TO WOMAN THAT HAVE HAD THE SAME PROCEDURE AND DO NOT EVEN KNOW ABOUT THESE COMPLICATIONS. YOUR BRAVERY AND COURAGE IS INSPIRATIONAL. ESPECIALLY FOR THOSE LIKE MYSELF THAT SUFFER THE COMPLICATIONS OF THESE "PROCEDURES"
YOUR FIGHT TO GET SUCH DEVICES OFF THE MARKET IS A TEMENDOUS EFFORT FOR SOMEONE THAT HAS BEEN THRU SO MUCH. YET, STILL SUFFERING,YOU CONTINUE TO FIGHT. NOT FOR YOURSELF, BUT FOR ALL WOMAN CAUGHT IN THIS SITUATION. YOU ARE AN HONORABLE WOMAN WITH A DRIVING FORCE THAT IS SO STRONG,WHILE YOU STILL SUFFER TODAY. I HONOR AND CONGRADULATE YOU FOR YOUR DRIVE TO GET THESE DEVICES OFF THE MARKET AND FOR FIGHTING SO STRONGLY THRU THE PAIN AND SUFFERING. YOU ARE AN INSPIRATION TO US ALL!! THRU TRAGEDY,YOU STILL FIGHT!! I SPEAK FOR ALL OF US THAT CONTINUE TO SUFFER,BY SAYING THANK YOU,THANK YOU, FOR YOUR TREMENDOUS BRAVERY AND COURAGE!!! THANK YOU!!!!!!!
GERI REINIGER

Anonymous User
Posted by Peggy
Friday, April 24, 2009 2:28 PM EST

I have just posted a comment on the first site but failed to mention that my urologist now tells me that I cannot have any additional surgeries. He doesn't say why and I believe he is covering up some info that he knows about this device. I hope, by posting, that I will be notified of any upcoming litigation. Doctors all stick together and when I asked my internal medicine physician to send me to a specialist he told me (with a blank look on his face) that he did not know of another specialist. Yea sure!

Anonymous User
Posted by Suzanne McClain
Saturday, April 25, 2009 1:18 AM EST

Peggy,

I'm sorry to hear of yet another mesh victim!

Get a copy of your doctor and hospital records immediately, and if you choose to do so, file an adverse event report with the FDA. If you have been harmed, you should give this serious thought, and I will be happy to help you do this accurately. To do so, it is imperative that you have these records as you will need the exact device, model number, lot number, and manufacturer.

If you need my help, email me at: aunt_sanner@yahoo.com

Best ~ Suzanne

Anonymous User
Posted by mom1965
Monday, April 27, 2009 12:59 PM EST

Its so nice to see people post on this site,hopefully meny more will sign it,,please if you know of anyone going to get this done (tvt)STOP them,its not worth all the pain and missery....I am still in pain it will be 2 years in aug,but whos counting!!!!!!!MOM

Anonymous User
Posted by GERI REINIGER
Friday, May 01, 2009 4:55 AM EST

THIS JUST MAKES ME SICK!! SURGEONS PUTTING IMPLANTED MATERIALS INTO THE HUMAN BODY WITHOUT EITHER KNOWLEDGE OF POSIBLE COMPLICATIONS AND FAILURE TO WARN PATIENTS BEFORE SUCH PROCEDURES. THIS IS WRONG,PLAIN,WRONG!!!!
I ALSO HAD PELVIC FLOOR RECONSTRUCTION BUT WITH GORE TEX MESH AND REPLIFORM GRAFT FROM BOSTON SCIENTIFIC.MY COMPLICATIONS STARTED DAY 2 AFTER THE PROCEDURE. I DEVELOPED A SEVERE INFECTION THAT LANDED ME IN A CRITICAL CARE UNIT,ON LIFE SUPPORT FIGHTING FOR MY LIFE.
I, LIKE SUZANNE WAS TOLD NOTHING ABOUT THE POSSIBLE COMPLICATIONS. EVEN AT DEATH'S DOOR,CLINGING TO LIFE,MY HUSBAND KEPT ASKING WHY THIS HAPPENED AND THE ANSWER WAS "WE DON'T KNOW"
I SURVIVED BUT FOR YEARS HAD MULTIPLE PROBLEMS AND NEVER HAD ANY KNOWLEDGE OF THE COMPLICATIONS THAT CAN ARISE WITH SYNTHETIC MESH.
SUZANNE,YOU SUFFERED GREATLY. AND TO HAVE THAT MESH IN YOU FOR 4 YEARS TIME TO WHICH IT EMBEDDED INTO YOUR TISSUES BEFORE YOU REALIZED YOU HAD A PROBLEM,IS CRIMINAL TO ME.
I THINK IT COURAGOUS TO TELL YOUR STORY OF ALL YOU WENT THRU TO HELP OTHERS. YOU TOOK THIS EXPERIENCE AND BECAME DRIVEN TO WORK AGAINST SUCH MATERIALS BEING PLACED IN THE HUMAN BODY.YOU ARE AN INSPIRATION TO ME. TO GO THRU ALL YOU HAVE GONE THRU AND WORK SO HARD TO HELP OTHERS IN THE SAME SITUATION OR POSSIBLY CONSIDERING SUCH SURGERY,YOU ARE A STRONG REMARKABLE WOMAN. I AM IN AWE OF YOUR DRIVE TO FIGHT FOR US ALL. YOU HAVE HELPED ME GREATLY AS I NEVER EVEN KNEW ANYTHING ABOUT SYNTHETIC MESH AND THE COMPLICATIONS I HAD RIGHT AFTER THE PROCEDURE AND SUFFERED FOR 8 YEARS STILL WITHOUT KNOWLEDGE AS TO WHY I WAS HAVING SO MANY PROBLEMS. I AM FILLED WITH MESH FROM THAT PROCEDURE AND A HERNIA REPAIR. AND, AGAIN,NEVER HAD ANY KNOWLEDGE OF ANYTHING REGARDING SYNTHETIC MESH. IT IS THANKS TO PEOPLE LIKE YOU THAT HAS TAKEN A TRAGIC SITUATION AND TURNED IT INTO A BATTLE TO HELP OTHERS.
YOUR DRIVING FORCE TO GET THIS STUFF OFF THE MARKET AND INFORM AS MANY PEOPLE AS YOU CAN JUST ASTOUNDS ME!!! IT IS THANKS TO ALL YOUR HARD WORK THAT YOU HAVE REACHED OUT TO HELP PEOPLE LIKE ME THAT NEVER HAD ANY KNOWLEDGE OF THE COMPLICATIONS OF SYNTHETIC MESH. YOU TAKE YOUR EXPERIENCE OF PAIN AND SUFFERING AND WITH A KIND,COMPASSIONATE AND EMAPTHETIC HEART,YOU TURN TRAGEDY INTO HELPING OTHERS LIKE ME. I THANK YOU. I NOW KNOW WHAT HAPPENED TO ME AND WHY. I NOW KNOW WHY I SUFFER SERIOUS COMPLICATIONS TO THIS DAY,THANKS TO YOU.
THIS STORY MUST GET TO THE NATIONAL MEDIA AND I ENCOURAGE ALL THAT READ SUZANNES STORY,TO STEP UP TO THE PLATE AND SUPPORT THIS WOMAN THAT CONTINUES TO DO BATTLE FOR ALL OF US.WE CAN'T TAKE THAT FOR GRANTED!!! WE SHOULD ALL TAKE A HARD LOOK AT OURSELVES.EACH AND EVERY ONE OF US THAT HAS SUFFERED IN ANY WAY DUE TO THIS IMPLANTED SYNTHETIC MESH. WE NOW HAVE ANSWERS. LET US ALL ASK OURSELVES IF WE WOULD HAVE THOSE ANSWERS IF NOT FOR SUZANNE McCLAIN. EVERY SINGLE PERSON MUST STEP UP TO THE PLATE,POST OUR COMMENTS AND WORK TO GET SUZANNES STORY OUT TO THE NATIONAL MEDIA. IF NOT FOR OUR OWN SAKE,THINK ABOUT ALL THE WOMEN THAT ARE SUFFERING COMPLICATIONS FROM SUCH PROCEDURES AND HAVE NO IDEA WHY THEY ARE SO ILL. THAT WAS ME 5 MONTHS AGO. I NEVER HAD ANY KNOWLEDGE AS TO WHY I NEARLY DIED AND WHY I STILL SUFFER THE COMPLICATIONS TO THIS DAY. TAKE NOTE, THAT I SUFFERED FOR 8 YEARS NOT KNOWING WHY MY SURGERY NEARLY KILLED ME AND WHY I NOW HAVE SO MANY SERIOUS COMPLICATIONS. I KNOW NOW AND AGAIN, I THANK YOU SUZANNE FOR REACHING OUT TO OTHERS AND FIGHTING SO HARD TO INFORM OUR NATION.
I ASK ALL TO POST COMMENTS TO THIS TRAGIC STORY. WE OWE IT TO SUZANNE TO DO THE RIGHT THING AND SUPPORT HER FIGHT. SHE HAS HELPED ME AND COUNTLESS OTHERS. SHE DESERVES RECOGNITION FOR HER HARD WORK AND HER COMPASSIONATE HEART. SHE IS NOT JUST WORKING FOR HERSELF,SHE IS FIGHTING FOR US ALL. SO, PLEASE, ALL THAT READ THIS,PLEASE POST A COMMENT SO WE CAN ALL GET JUSTICE!!!!
GERI REINIGER

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