Hernia Mesh Patch Recall - FDA Warns ...

Hernia Mesh Patch Recall - FDA Warns of Death and Serious Healt...

There are 8247 comments on the PRWeb story from Feb 4, 2007, titled Hernia Mesh Patch Recall - FDA Warns of Death and Serious Healt.... In it, PRWeb reports that:

Patients should review the latest recall information to see if they have been implanted with the recalled device and seek medical attention if symptoms such as unexplained or persistent abdominal pain, fever, ...

Join the discussion below, or Read more at PRWeb.

Lana Keeton

Lakewood, CA

#1295 Aug 31, 2008
Mike from Philly wrote:
I just received a letter from the FDA August 11, 2008. It states that in reviewing existing events, FDA has determined that many of the adverse events are NOT due to an inherent problem with the implanted material but with where and how the mesh is implanted. If the mesh is not properly placed or properly secured, it can detach and migrate, resulting in painful sequelae. The goal of our labeling review and patient information is to make physicians and consumers more aware of potential adverse events and steps to be taken to avoid such problems. It is important to keep in mind that FDA does not regulate the practice of medicine, which is overseen by the state, nor does the Agency specify what type of training a surgeon must have to make use of these meshes in their practice.
The letter was delivered to Senator Casey. I sent him letters in March. I just typed the last two paragraphs. The typed name at the bottom is from Stephen R. Mason. But the person who signed it, I can't make out their signature. My complaint is against the Bard Perfix Hernia Plug of Murray Hill, New Jersey.
Hi Mike,

I have info for your reply letter to Mason. I saw the same letter written to someone else.

There is no way the FDA can make that determination from the adverse event reports.

Contact me at miamiblog @ bellsouth.net .

blessings, Lana
Debbie

Louisville, KY

#1296 Sep 1, 2008
Hi Mikail -- the synthetic meshes on the market ALL have serious life-altering complications associated with them....sooner or later...years later sometimes....Dr Richard Miller at Vanderbilt University in Nashville, Tn is an excellent trauma surgeon specializing in complicated hernias. He will also remove synthetic mesh and if a mesh is needed, he uses Alloderm and/or Strattice, both biological meshes and much safer than anything on the market. The problem with stitches are the same with synthetic mesh. They are both made of the same materials, the only difference being one vs thousands. The stitches oftentimes have the same complications, just not on as grand a scale. This info can be found on FDA database....just takes time. As far as infections go...let's just face it...they're out there. If you must have a surgery though, try to plan to have it in the cooler months of winter...just a thought. Also, ask your hospital of choice what their infection rates are at present. Good Luck...I've had a bad experience with mesh but after numerous surgeries, finally feel like I might eventually have a life again.
Mikail wrote:
Hi! I have read the terrible complaints of those who had hernia mesh patch surgically resulting with infections and pains etc. I had a surgery with stitches technique about 25 years ago from the left side and it broke three years ago. Now, the doctor I have visited, suggests me to implant one mesh patch on each side. But, after reading these experiences, I am scared to opt for the mesh. Perhaps, stitches would be safer. If I accept the doctors suggestion for mesh surgery, what should I pay attention to for a safe and successful surgery? Which mesh would be advised? How can infections be prevented?
Thank you for the help
Debbie

Louisville, KY

#1297 Sep 1, 2008
Mark --- call Dr Richard Miller at Vanderbilt University in Nashville,Tn. His credentials are out-standing. He is Professor of Trauma at Vanderbilt and specializes in complicated hernia repair with biological mesh...Alloderm/Strattice. He also removes synthetic mesh. He repaired my enormous hernia and I'm very happy with the results.
Mark wrote:
I had a hernia surgery back in Nov. of 07 I had had a surgery for a different hernia about 7 years ago,the Dr. used mesh,I started bleeding from my navel a few months after surgery,I went to see the Dr. he said oh I just have to cauterize it.It seemed ok for a few days then started bleeding again,I made an appointment went beck in a few weeks and the Dr. starts probing around and says oh boy,your body is rejecting the mesh.So what was happening was the mesh was coming out of my navel.I had to go in for surgery and have the mesh removed.So when I went in for the surgery in Nov. I told the Dr. don`t use mesh,it was the same Dr. he said why not?I said the last time you used it I rejected it and you had to take it out,he was liek oh ya I remember now.Anyways I went for a pre op exam and they were asking me all the usual questions and they said the Dr. has you down for mesh.I said no,no mesh then I explained to them what happened last time,they said ok and changed it.The day I went in for surgery I told the lady admitting me about it,she made one of those plastic bracelets and it said no mesh on it.I had a feeling the Dr. was going to use mesh and didn`t want it.When I woke up after surgery I noticed the bracelet was gone I asked my wife where it went,she said the Dr. cut it off,and he used mesh.I was really pissed off to say the least ,when I asked him about it,he said the hernia was too big to not use the mesh.I don`t really buy that what did they do before the mesh?Anyways I told him thanks alot you`re just going to end up removing it again,he said oh no I used a different type of mesh one that (I think he said is inert)anyways I had a reaction to it.THe area where the mesh was used is swollen up really bad.I wanted him to do something about it right away,he said I`m not touching it until June,this was in December,anyways I went back 2 more times he told me both times I don`t care how many times you come back I`m not touching it until June.I got pissed off and decided to hell with that hack ,anyways I`m not having any luck getting another dr to look at it,they don`t want anything to do with his screw up is basically what they tell me.So I`m going to the emergency room and see if I can get them to do something or refer me to another Dr. the one I had sucked ,he has a God complex I can`t and won`t deal with him anymore .

Since: Apr 07

stockton ca

#1298 Sep 1, 2008
Here is a copy of the letter I recieved from Ethicon...I had sent then my op reports along with the pic of the mesh with my nerves hanging out of it...
August 21,2008
Re:
PHSM - PROLENE Hernia System
Dear Ms.Kaiser:
Thank you for telling us about the experience you had with PHSM - PROLENE Hernia
System. You reported in a Voluntary Medwatch form that you developed severe pain post operatively, which continued arid required pain management with injections of cortisone and epidural through the summer of2006. You reported that additional surgery was indicated to remove the mesh and some entangled nerves.
PROLENE Hernia System is a sterile pre-shaped, three-dimensional device constructed of knitted non-absorbable polypropylene filaments. implantation studies show that implantation of PROLENE Mesh elicits a minimum to slight inflammatory reaction, which is transient and the process incorporates the mesh into adjacent tissues.
ETHICON is not able to neither provide any diagnostic evaluations nor make any specific recommendations other than to seek qualified medical attention. Your physician will be able to advise you, taking into consideration, your medical profile including any known allergies or medical conditions that would contradict the use of certain products.
We apologize for any inconvenience your experience may have caused you. Please call me directly at if you need any additional information.
S1hcerely,
Regina Bruttell, RN
Worldwide Customer Quality
Brian Zampatti

Gibsonia, PA

#1299 Sep 2, 2008
I had a triple hernia repair in October of 2005, I have had blood in my stool 2-5 timess a month, soarnes around the surgery areas, at times I find myself falling to the ground due to unbearable sharp pain going from butt threw my penis. I have had 2 colon scopes, cysto scope and all the doctors tell me I am okay. I have heart problems, stomach problems, heartburn, chestpains, ED, numbness in my legs/feet, no answers. I have called Johnson and Johnson, I wrote them and received a letter back stating that their product isn't the problem. I never asked to be fix just to have more problems and live a life of misery at the age of 30.
Mark

New York, NY

#1300 Sep 3, 2008
thank you for the info Debbie.But I am in NY state and can`t afford to go to Nashville unfortunately.Mark
Debbie wrote:
Mark --- call Dr Richard Miller at Vanderbilt University in Nashville,Tn. His credentials are out-standing. He is Professor of Trauma at Vanderbilt and specializes in complicated hernia repair with biological mesh...Alloderm/Strattice. He also removes synthetic mesh. He repaired my enormous hernia and I'm very happy with the results.
<quoted text>
Bruce

Boca Raton, FL

#1301 Sep 3, 2008
Mark wrote:
thank you for the info Debbie.But I am in NY state and can`t afford to go to Nashville unfortunately.Mark
<quoted text>
Mark,
Please contact me at [email protected] ,if it doesn't work try me at [email protected] . The National Meshoma Foundation will help you get to Nashville or possibly another surgeon who might help you. There is no catch, just helping patients get the most accurate diagnisis and treatment plan is is the goal. This increases proper documentation of these injuries, and increases your chances of some recovery. It helps all of us and future hernia patients. Anyone else out there in the same predicament please contact me.

Feel better,

Bruce
National Meshoma Foundation
Bruce

Boca Raton, FL

#1302 Sep 3, 2008
Brian Zampatti wrote:
I had a triple hernia repair in October of 2005, I have had blood in my stool 2-5 timess a month, soarnes around the surgery areas, at times I find myself falling to the ground due to unbearable sharp pain going from butt threw my penis. I have had 2 colon scopes, cysto scope and all the doctors tell me I am okay. I have heart problems, stomach problems, heartburn, chestpains, ED, numbness in my legs/feet, no answers. I have called Johnson and Johnson, I wrote them and received a letter back stating that their product isn't the problem. I never asked to be fix just to have more problems and live a life of misery at the age of 30.
Brian,
You're not alone, not crazy...it's not you. J & J has been terribly remiss in their reaction to these complications...criminal really.
They knew prior to selling these products that the mesh can contract with scarification, and that this contraction can entrap nerves. The removal of the products cause greater injury than just a traditional recurrance redo would...You're in a tough spot so you need to go directly to one of the few specialists in this. Please contact me at [email protected] or try [email protected] This wasn't your fault. Make sure you have your surgeon file the 3500 Adverse Event report to the FDA (go to www. fda.gov ) Get your scans and reports asap. Be proactive and don't give up.
Feel better,

Bruce
National Meshoma Foundation
Steve

Cincinnati, OH

#1303 Sep 4, 2008
Had hernia surgery 8-4-04 with constant pain and erectile disfunction. Went to my doctor yesterday 9-3-08 and he told me that he used marlex mesh and that only 2% of patients have a problem. My doctor said I need to have it redone and wants to use the marlex mesh again. Surgery scheduled for 9-22-08. Help, don't know what to do. Steve [email protected]
Debbie

United States

#1304 Sep 4, 2008
Brian -- I'm so sorry this has happened to you and all the rest of us. But I'm here to tell you that there is help. I'm living proof that you can have this harmful stuff removed and here's the name of the surgeon who can do it for you. His name is Dr Richard Miller, Professor of Trauma at Vanderbilt University in Nashville, Tn. Please don't agree to surgery until you speak with him. He specializes in difficult hernia repairs. He is a trauma surgeon first and foremost, and has removed over 200 synthetic meshes and repaired the hernias with biological implants, when and if necessary. I had a horrible mesh removal by a different surgeon and was left with a tremendous hernia and several surgeries as a result. I only wish I'd known of Dr Miller before the removal. He is a brilliant surgeon with lots of experience and well worth the trip to see him. He repaired my massive hernia with Alloderm and Strattice and I couldn't be happier with the results. I am actually resuming my life again and I really didn't think I ever would. I urge you to make the call and see him. Most surgeons don't have the experience or skills to deal with this type surgery and the outcome can be devastating in inexperienced hands. Trust me, I know. Also, I saw 6 different surgeons before finding him and they all recommended a piece of synthetic mesh, from hip to hip. I said, no thanks, I'm not that crazy yet. After all, it nearly killed me once. I did my homework. I found out what material were safest and kept researching till I found a surgeon qualified to do it. Please don't let another surgeon put more mesh into you. Good Luck and God Bless. Feel free to e-mail me at [email protected] for more info if you'd like.
Deb
Bruce wrote:
<quoted text>
Brian,
You're not alone, not crazy...it's not you. J & J has been terribly remiss in their reaction to these complications...criminal really.
They knew prior to selling these products that the mesh can contract with scarification, and that this contraction can entrap nerves. The removal of the products cause greater injury than just a traditional recurrance redo would...You're in a tough spot so you need to go directly to one of the few specialists in this. Please contact me at [email protected] or try [email protected] This wasn't your fault. Make sure you have your surgeon file the 3500 Adverse Event report to the FDA (go to www. fda.gov ) Get your scans and reports asap. Be proactive and don't give up.
Feel better,
Bruce
National Meshoma Foundation
Debbie

United States

#1305 Sep 4, 2008
Mark -- I can't impress upon you how important it is to have a highly experienced and qualified surgeon to do this and Dr Miller has done over 200 of these complicated mesh removal/hernia repair surgeries. I know the financial burdens from these mesh complications can be devastating but regaining your health is the only way you'll ever become financially independent again. Maybe there are other highly experienced surgeons out there but I did my homework and can tell you from experience that my trips to Nashville were well worth the effort and I highly recommend him. I have a friend who is in very poor health due to mesh complications with little means but has made the trip from Indiana to see him and has elected to have him do the surgery. Drs had told him to get his affairs in order as there was too much damage to remove it but Dr Miller, having many years experience as a trauma surgeon, is willing and able to help him. So, just food for thought. I know I sound like his personal fan club and maybe I am. I know what he did for me. But more importantly, I know from experience what can happen when the wrong surgeon is selected. The surgeon who removed my mesh was a world-reknowned surgeon who said he'd performed 1000's of these mesh removals. Obviously, he didn't and things went badly almost immediately. I was hospitalized for 6 wks, most of that in ICU. I nearly died, over and over. The good dr had perforated my bowels. I had a colostomy and the incision became infected. I developed an Ileus and huge hernia as a result. AFterwards, I had to undergo 4 more surgeries to correct the damage, including the hernia repair by Dr Miller, and it wasn't done with more mesh either. So, taking the cost of all this into consideration, I have just one thing to ask. What's it worth? You can't put a price on your life and health. My point is that these mesh materials imbed themselves in your bowels, cut into soft tissue and the scar tissue wraps around all your organs then turns to a concrete-like substance. Unlike, Dr Miller, most surgeons don't see trauma patients; victims of gunshot wounds and car accidents on a daily basis and therefore are not so accustomed to dealing with the body being so mutilated. These surgeries are very complicated and tedious and require someone who knows what they're doing. Which is what Dr Miller now specializes in; complicated hernia repairs. Just please make certain your surgeon has lots of experience, whomever you choose and feel free to write back at [email protected] Good Luck and God Bless
Deb

Mark wrote:
thank you for the info Debbie.But I am in NY state and can`t afford to go to Nashville unfortunately.Mark
<quoted text>
AOL

United States

#1306 Sep 4, 2008
good luck Brian
Mark

New York, NY

#1307 Sep 4, 2008
Hi Debbie,I will check into it.If there`s a way to make the trip I will do it.I just want it fixed,it`s pretty much put a stop to my life.Thanks for the advice.Mark
Debbie

United States

#1308 Sep 4, 2008
Ellen
Hi. I also had mesh placed for prolapse issues and would like to discuss this with you. Please email me at [email protected]
Deb
Ellen wrote:
I would like to let you all know that I just had 95% of the mesh removed from my vaginal and rectum area it all had to be disected out I found a wonderful Doc at stanford the problem is that first of all they use a forien product in your body ,and don't test it to see if there is any rejection second they put something in you and no one knows how to remove itI have suffered for over a year could not sit down severe pain had to get on line to find my own help my Doc did not know what to do Sad I feel ike I was a ginny pig and someone should be responsible for all my pain and suffering I just had this removed august 28 2007 not even a month ago I can not sit and still can't walk very painful I WOULD LIKE EVERONE TO PLEASE DO LOTS OF RESEARCH BEFORE YOU EVER HAVE TO SUFFER LIKE I HAVE ALSO DON"T LET THESE DOCS PUT FORiEN OBJECTS IN OUR BODY THEY CAN SEW IT UP TRADITIONALLY AND IF IT ONLY LAST A FEW YEARS IT"S BETTER TO GO BACK FOR A REPAIR THAN HAVE TO SUFFER LIKE I HAVE If any one has any civil suits going let me know
Debbie

Louisville, KY

#1309 Sep 8, 2008
ALL YOU EVER WANTED TO KNOW ABOUT SYNTHETIC SURGICAL MESH --for all who are suffering with mesh complications and/or are considering undergoing surgery with a mesh implant....we are conducting a meeting in the Nashville, Tn area to educate the public-at-large on the risks and complications of these mesh products and procedures. Dr Richard Miller, Professor of Trauma at Vanderbilt University, will be guest speaker. He specializes in mesh removal and complicated hernia repairs with biological mesh. We are in the process of trying to have the meeting streamlined for viewing. However, if you or loved ones are experiencing post-surgical complications of mesh or are contemplating a surgery requiring the use of synthetic mesh or removal of mesh....this is a must see. For more info email me at [email protected]

“mean people suck”

Since: Feb 08

Muskegon, Michigan

#1310 Sep 8, 2008
at last there is one dr. out there that cares. maybe we should invite him to the fight with the FDA? anyone ever hear of this before?

http://www.geocities.com/desarda/
Debbie

Louisville, KY

#1311 Sep 9, 2008
ElsieP wrote:
at last there is one dr. out there that cares. maybe we should invite him to the fight with the FDA? anyone ever hear of this before?
http://www.geocities.com/desarda/
Elsie
Very interesting article and I noticed the link to this site. I only wish more surgeons would re-educate themselves regarding the complications of these mesh products and on perfecting the art of explanting them instead of using the age-old policy of CYA. While they're convering their own butts they're also covering for the pharma. com. and IMHO continuing to do the public a gross injustice.
Deb
KenG riffiths

Burnaby, Canada

#1312 Sep 9, 2008
i had my number 5 left hernia surgery & mesh put in 4 times in the left groin. last surgery was oct/1998 have horrific pain, burning, mesh feels like it moves, also get a temperature almost daily. sleep is very difficult as well. Dont know what mesh i got in 1998--anyone out there think it must be defective? Docs will not remove it for fear i will hemmorage to death. Any legal position i can take with this? thx ken griffiths
Debbie

Louisville, KY

#1313 Sep 10, 2008
Ken -- I can't speak directly to the problem of inguinal hernia repairs but there is someone on this blog that is extremely informative on this particular topic. His name is Bruce and I'm sure he'll enlighten you. It sounds as though the mesh may be floating or migrating. It may have also have encapsulated nerves. You need to get your medical records to determine what kind of mesh you have. Also, the fever is indicative of infection. One question...why do the drs suspect hemmorage is likely? IMHO all synthetic mesh is defective. The plastics/petroleum materials they're manufactured from are well-documented irritants and in some cases, carcinogens, not intended for use in the human body. As far as legal representation...all I can tell you is that many individuals are working towards that goal as we speak. Quite a few are speaking directly to the FDA, Congressmen and some are getting much-needed media attention to bring this horrific problem to the forefront. Some surgeons are finally getting on the bandwagon to end the use of synthetic meshes. I hope this helps in some small way. Good Luck and Godspeed, Ken.
Deb
GDSM

Browns Mills, NJ

#1314 Sep 10, 2008
Ken...as Debbie says, you must get your medical records to know what kind of mesh you have implanted. There are many complications that these products hold for the patient as you well know, The fever is indicative to an infection and you should have that checked by your family doctor, a simple blood test will show if there is an infection present. It does sound as if the mesh could be rubbing or has affected the nerves in your groin, the sad part is that there is no test that can show this, the only hope is that the technician and doctor reading the test results are very well trained and can see something. It is possible to see a meshoma but they really need to be looking for that. You should also do what many, many other her have done and file an adverse event form with the FDA the link is www.fda.gov/medwatch . Chances are your next step will be pain management for Cortisone injections and pain medication. OI have found that if the first series of injections do not work they never will and is a tell tale sign that it is the mesh that is the problem. Once you have your records in hand and know what kind of mesh is inside of you and the injections have not worked, it is time to look for explantation of the mesh. This is when you need to be very careful as there are not many skilled hands in the surgical field that can remove mesh. It is also possible that there may be an errant tack if that is what they used to fixate the mesh in your body. You also did not mention if your surgery was open or done Laporiscopilly. Usually Lap surgery is when the tacks are used, the good thing here is that the tacks will show on CT scan and MRI. If you have to have the mesh removed and then have the Neurectomy done be prepared for massive bruising. when I had mine done the bruising reached all the way up to where my kidney is and down into my upper left thigh, The bruising was very dark purple, almost black.
Good luck and keep us posted on you your treatment.

Tell me when this thread is updated:

Subscribe Now Add to my Tracker

Add your comments below

Characters left: 4000

Please note by submitting this form you acknowledge that you have read the Terms of Service and the comment you are posting is in compliance with such terms. Be polite. Inappropriate posts may be removed by the moderator. Send us your feedback.

Edgecliff Village Discussions

Title Updated Last By Comments
Looking for Green Decendants Fri Debbie 1
Paschal High School 80's LGBT Reunion Fri Dana Arnn 6
missing people in fort worth area Nov 30 irma Jaramillo 1
News Texas Democrats lament first presidential elect... Nov 28 Graybeard Geezer ... 22
News Application process takes new route (Nov '06) Nov 28 Mary Mindieta 5
gang stalking in dfw (Feb '16) Nov 28 Donedirtcheap 21
Kacie Mcdaniel Makes The Mugshot Hottie List Nov 27 John Gotti 1

Edgecliff Village Jobs

More from around the web

Personal Finance

Edgecliff Village Mortgages