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.

Seth

Carnegie, PA

#2361 Jun 28, 2009
I think what PeterB wants to know is:
(1) Have the surgeons that have used Rebound HRD had good luck with it?
(2) Is it starting to catch on?

P.S. the hernia MD (whatever his name is), has blasted Rebound HRD as being an incompetent product. I am just putting what he said in my own words, etc.

I have spoke to a surgeon who has been using Parietex and has had no problems with it. My own personal interest would be Parietex vs Ultra Pro. What is the better product?

Why are some people having problems with mesh retraction/migration and others are not? If the mesh is balled up and tough to remove, then it certainly cannot be from any collagen disorder like Goodyear tries to say. If a person's particular collagen will not adhere to mesh than the mesh would be easy to remove whether balled up or migrated. This Dr. Goodyear and other surgeons who promote this theory are way off base.

Seth
wolf99

AOL

#2362 Jun 29, 2009
Type in: Parietex many issues dealing with topic on patentstorm.com , US Patent Application 20060015142 Plug made of mesh material for closing large trocar wounds: this is under (Parietex) on patentstorm.com
Dave

Belle Fourche, SD

#2363 Jun 29, 2009
Seth wrote:
I think what PeterB wants to know is:
(1) Have the surgeons that have used Rebound HRD had good luck with it?
(2) Is it starting to catch on?
P.S. the hernia MD (whatever his name is), has blasted Rebound HRD as being an incompetent product. I am just putting what he said in my own words, etc.
I have spoke to a surgeon who has been using Parietex and has had no problems with it. My own personal interest would be Parietex vs Ultra Pro. What is the better product?
Why are some people having problems with mesh retraction/migration and others are not? If the mesh is balled up and tough to remove, then it certainly cannot be from any collagen disorder like Goodyear tries to say. If a person's particular collagen will not adhere to mesh than the mesh would be easy to remove whether balled up or migrated. This Dr. Goodyear and other surgeons who promote this theory are way off base.
Seth
I think it is a very good product. I have used it in close to one hundred patients. Do not need to place tacks laterally since the mesh is self supported. Easier to place for surgeons who do occasional lap hernia since mesh doesn't fold upon itself. Uses latest lightweight polypropylene. Not well known simply because manufactured from small start up medical company with big roots in Minnesota. Only down side is cost, but in reality fairly comparable to that offered by Bard and Ethicon.
Kenneth

Bremerton, WA

#2364 Jun 29, 2009
For Dave
I was referred to you by someone else in my area who came across this website just recently.
I am having some hernia problems which go back quite some time. I would like you input into this situation. I have had problems with mesh retraction with the older type of mesh called Marlex. I am sure you have heard of it.

I originally had a lap. Marlex mesh put in back in 2002. It seemed to work for a little while and didn't give me any pain until about a month later after the operation. The groin pains got progressively worse. Then another surgeon who does modified Shouldice went in an found a hernia. He supposedly repaired it with a Shouldice repair all the while leaving the laproscopic mesh intact. A few years ago, I had the mesh removed (as it had balled up) and taken out laprocopically. The mesh replacement was with UltraPro. This is the lightest mesh made by Ethicon. I had some adhesions removed a few times until finally things were quite settled down. There was minimal discomfort. But just during the last month, I think I did something to damage the repair. The first time I reached down to my left at work to pick up a piece of paper and I could feel a little strain in the left groin. Then about a week or so after that, I was getting out of my car and reached down while sitting in it to pick up a grocery bag and coughed at the same. I could feel a lot of pressure in the left groin. It felt like something happened. From this point and especially the last few days the groin is really bothering me. I am thinking about asking my surgeon for a lap.exploratory to see what has happened. I am in a lot of discomfort.
Can you please tell me if you think I did some damage and if so, can it be fixed laparoscopically?
Molly

Kapaa, HI

#2365 Jun 29, 2009
Hi, I had a femoral hernai on the right side laproscopically repaired in 1998 with SURGIPRO mesh in Honolulu through Kaiser with a general surgeon.
I had no problems until last year when mysterious bowel issues turned up, mucus and blood and some urgency... it has gotten worse over time and has incapacitated me since around October 2008. I cannot work. I am either constipated, straining to make small bowel movements, sometimes 50 times in a 24 hour period, or incontinent... yes, at age 42, been in perfect health up until this, even eating a high fiber diet did not fix things... still the same... sometimes a lot of blood, usually no blood but very severe chronic hemmroids have developed and flare almost all the time to some degree or another. I am often unable to leave the house until late in the day as all morning and afternoon are spent between the toilet, the hot bath, laying on my stomach and trying to get things done whenever I have a break. I realize this is serious. I have been into natural healing and always have cured myself of things. Never has my body not recovered from dis ease or discomfort in a matter of days... In fact, the only medical problem I ever had in my entire life was that small hernia which I had repaired and only afterword heard from the Philipino nurse that it was probably not necessary, that people live with these in other countries... I was sonfident that all would be well at the time I was not into natural healing. Since then I have had excellent health even going on a raw food diet for months at a time and had the most complete, simple and large bowel movements as anyone could have before this started up last summer/fall. Now I am all twisted and tight on the right side and bowel movements are a huge ordeal requiring maximum attention, straining and toilet paper useage and yet yeilding very small thin stools. I am small at 95 pounds but this is ridiculous since I used to have regular soft easeful movements right up until this began. Now this is ten years after the surgery so it did not dawn on me at first... I thought it was detox... or something I could cure with diet and excersize... lo and behold. nothing worked. Even a move back to Hawaii, which I thought would help, has done nothing. This is a stubborn and I believe non organic problem... meaning it cannot be cured by natural methods. Belive me I have tried many, herbs, colon cleanse, colonics... and eating almost all fiber, as well as eating low fiber cooked food. Unlike other organic physical issues, nothing significantly reduces or totally fixes this.
Only complete non eating gives relief.
Is it possible that the mesh or the staples could have suddenly caused this out of the blue after ten years of nothing? I have read the possible complications being biomaterial related intestinal obstruction or fistula formation... but after ten years? I have been to the emergency room and Urgent care a few times in chronic pain but I am not one to use the medical community. However if it is the mesh or staples then I have no choice. Is this a possiblilty that I should seriously consider? I think so but I thought some feed back from here may be helpful. It is no easy task to see a specialist! But if I must, what kind of MD do I need to see to have this explored? Will an MRI tell all? What test can be done to determine if the mesh or staples have gone astray?
dirty rat

AOL

#2366 Jun 30, 2009
robin rowray

AOL

#2367 Jun 30, 2009
Karen M wrote:
In December 2005 I hve a hernia repair with the Marlex/Prolene Patch. My symptoms starts immediatey. I had drain after drain placed in me. Also the JP pump could not get it all so the dr. used an 18 gage needle every 4-5 days and asperated the site. Iwas told that recovery could take up to a year. Besides the burning and pain where the hernia was. I have an 8x10 mesh patch that mkes the skin numb, but the pain is still under neath. I cannot eat 3 mels a day, because the pain is too severe. I also have a bulge from my stomach being stretch. I am tired all the time, losing weight fast. When I had the surgery I weighed 126 lbs, now I barely can hang onto 115. I have alot of buning sensation right were the repair was done. I am doing alot of investigating. The Prlene Mesh owed by Marlex has admitted to purchasing conterfeit mesh. How do we know if we all received on. My attorney is sending me to a surgeon and he is going to perform a Lapraoscopy to look inside and dtermine the damage, then we will go from there. Have you had nasea, vomitting, pain especially after eating, a burning sensation around the point of the hernia. I do all the time. Let me know how you are doing and anyone else. Bard originated this mesh, but all the other companies have made it to the same specification that Bard had the patent for. So what are the chances that we all have defective patches?
karen CANGBRAT@AOL>COM
Hi Karen:
I am not sure yet what type mesh was used on me. I had my surgery 6 weeks ago and have been miserable ever since . I have burning and numbness in the area of the mesh. I feel sick to my stomach all the time. I have went from 140 to 126 pounds.Now that I have been reading all the complications people have had I am definetly going to look into the type of mesh that was used. I have had 2 nerve blocks, and am now on neutontin. No real help yet. My next alternative is another surgery.
robin rowray

AOL

#2368 Jun 30, 2009
karen. I had inquinal hernia repair 8 weeks ago and have been miserable ever since. I have numbness and burning over the mesh area. I still have swwelling in that area. I am sick to my stomach all the time. I have went from 140 healthy pounds to 126 weak pounds! I am not sure what type of mesh was used but I will find out now!!!! I have had 2 nerve blocks and am now on nerontin for so called nerve damage! This is all unreal for such a minor surgery!
Molly

Kapaa, HI

#2369 Jun 30, 2009
some info:
"Femoral Hernias - more common among females. Occurs when part of the intestine protrudes through the femoral canal, it juts through at the top of the thigh. Blood vessels that supply the legs with blood go through the femoral canal.... "
"Gastrointestinal experts say that despite faster recovery time and less pain after the operation, laparoscopic surgery carries a higher risk of damage to the bowel. A European study found that laparoscopic hernia surgery has a 5 in 1000 risk of serious complications, compared to 1 in 1000 with open hernia surgery (NHS Choices, UK)...."
Howie

Centreville, VA

#2370 Jun 30, 2009
Misleading info by Dr. Goodyear. He is blaming a collagen dissorder for failing mesh repairs. This is not true. It is simply the properties of mesh. There is no evidence of this.

Now it is true that mesh can be rejected. What happens then is it balls up or the body tries to push it out. That is why Parietex mesh is better in some cases. It is made out of polyester.

You may notice now he is not answering as many questions.

Howie Green
Dave

Belle Fourche, SD

#2371 Jun 30, 2009
Kenneth wrote:
For Dave
I was referred to you by someone else in my area who came across this website just recently.
I am having some hernia problems which go back quite some time. I would like you input into this situation. I have had problems with mesh retraction with the older type of mesh called Marlex. I am sure you have heard of it.
I originally had a lap. Marlex mesh put in back in 2002. It seemed to work for a little while and didn't give me any pain until about a month later after the operation. The groin pains got progressively worse. Then another surgeon who does modified Shouldice went in an found a hernia. He supposedly repaired it with a Shouldice repair all the while leaving the laproscopic mesh intact. A few years ago, I had the mesh removed (as it had balled up) and taken out laprocopically. The mesh replacement was with UltraPro. This is the lightest mesh made by Ethicon. I had some adhesions removed a few times until finally things were quite settled down. There was minimal discomfort. But just during the last month, I think I did something to damage the repair. The first time I reached down to my left at work to pick up a piece of paper and I could feel a little strain in the left groin. Then about a week or so after that, I was getting out of my car and reached down while sitting in it to pick up a grocery bag and coughed at the same. I could feel a lot of pressure in the left groin. It felt like something happened. From this point and especially the last few days the groin is really bothering me. I am thinking about asking my surgeon for a lap.exploratory to see what has happened. I am in a lot of discomfort.
Can you please tell me if you think I did some damage and if so, can it be fixed laparoscopically?
From reading your story, I wonder if you may have a recurrent hernia. A surgeon may be able to pick this up with a simple examination. You've got a couple ways to go, in regards to open exploration vs. laparoscopic, but if you were my patient, I would probably recommend a laparoscopic TAPP repair. If you have a recurrent hernia I would see if the older mesh can be removed, or at least dissected off of your inguinal floor (can be tricky). I think that Rebound HRD is an excellent mesh especially if you have recurrence from a large direct defect (let me know if you don't understand indirect from direct herias). The advantage of this mesh is it's ability to avoid inward migration of mesh. Some of my patients feel a little "stiffness" in their groin initially, but this softens up within a month. I do like Parietex for a number of other hernias, but have found it difficult to place in laparoscopic inguinal repairs. I tend to use C-QUR light for all indirects, and small directs.
Dave

Belle Fourche, SD

#2372 Jun 30, 2009
If you had a femoral hernia, you needed to have this repaired. This is a mechanical problem that cannot be fixed without surgery. True the odds of bowel incarceration from hernias is low, but can be deadly. I had a patient with a femoral hernia that incarcerated and killed off a portion of his small intestine. Required a large midline incision with a bowel resection, and a two week hospital stay.
With blood in your stools, straining, and pencil thin stools, you need to see a gastroenterologist, or a surgeon who does endoscopy. I diagnosed a woman in her 40's with similar history to what you are describing with anal cancer a few weeks back.
Dave

Belle Fourche, SD

#2373 Jun 30, 2009
Molly wrote:
some info:
"Femoral Hernias - more common among females. Occurs when part of the intestine protrudes through the femoral canal, it juts through at the top of the thigh. Blood vessels that supply the legs with blood go through the femoral canal.... "
"Gastrointestinal experts say that despite faster recovery time and less pain after the operation, laparoscopic surgery carries a higher risk of damage to the bowel. A European study found that laparoscopic hernia surgery has a 5 in 1000 risk of serious complications, compared to 1 in 1000 with open hernia surgery (NHS Choices, UK)...."
Better repair laparoscopically. Open you simply shove a rolled up piece of mesh into your femoral canal.
Kenneth

East Saint Louis, IL

#2374 Jun 30, 2009
Questions for DAVE: I am the one who wrote about maybe causing a hernia myself by bending down to pick something up and then coughing. I should also say that at work, I sometimes leaned down to the left and it put a strain in the area just a little before this incident. Now I turn completely to the left and then make sure there is no strain anywhere. But I think I already done the damage. I am going to try to get in and ask for a diagnostic lap examination.
(1) I had adhesions because when he went in to replace the mesh, there was not enough omentum. These adhesions were removed. Is there a danger the adhesions will come back or get worse if he does another repair as you say?
(2) Will the surgeon have to do a lot of dissection to detect the problem?
(3) The pain I have radiates to the left hip, just like the original hernia. I can't see one though. I think Advil will reduce the hip pain. I don't like taking pain killers. It also radiates a little upward. Sometimes it will almost mysteriously disappear or get almost pain free but it doesn't happen that often. Could it be that the hernia "sort of pushes out at times" which causes more pain? Could this be from pressure from the intestines?
Dave

Belle Fourche, SD

#2375 Jun 30, 2009
Kenneth wrote:
Questions for DAVE: I am the one who wrote about maybe causing a hernia myself by bending down to pick something up and then coughing. I should also say that at work, I sometimes leaned down to the left and it put a strain in the area just a little before this incident. Now I turn completely to the left and then make sure there is no strain anywhere. But I think I already done the damage. I am going to try to get in and ask for a diagnostic lap examination.
(1) I had adhesions because when he went in to replace the mesh, there was not enough omentum. These adhesions were removed. Is there a danger the adhesions will come back or get worse if he does another repair as you say?
(2) Will the surgeon have to do a lot of dissection to detect the problem?
(3) The pain I have radiates to the left hip, just like the original hernia. I can't see one though. I think Advil will reduce the hip pain. I don't like taking pain killers. It also radiates a little upward. Sometimes it will almost mysteriously disappear or get almost pain free but it doesn't happen that often. Could it be that the hernia "sort of pushes out at times" which causes more pain? Could this be from pressure from the intestines?
Double check this with a physician. Could it be possible that your pain may be from other reasons such as arthritis or inflammation in the sacroiliac joint?

Adhesions can always come back.
Kenneth

East Saint Louis, IL

#2376 Jun 30, 2009
Dave, I had a check with an orthopedic surgeon about a year and one half ago he said I did not have arthritis or was in any immediate danger of getting arthritis. I was at this clinic because it was were I got some cortisone shots.
Some of them seemed to help but some did not prior to my surgeries.

It makes me wonder if you are right. Maybe this bending down strained some area where adhesions were and caused them to come back. Is this possible?

Thanks
poohbear913

United States

#2377 Jul 1, 2009
my mother had a lrge com.kugelmesh inplanted in her in 2005 had a recall in 2005 dec. did not hear of the recall till 2007 she did have it removed in 2005 but she died of fustilue fungus in her blood it caused her colan to split she was in hosp. 3weeks waiting to have colan fixed but when the time came she was in intensive care unit @ was having all kinds of problems they put her in intensive care icu, on weds, that fri she was suppose to have surgery she passed on.
poohbear913

United States

#2378 Jul 1, 2009
she passed in nov of 2005.
hernia shadow

AOL

#2379 Jul 2, 2009
poohbear913 wrote:
my mother had a lrge com.kugelmesh inplanted in her in 2005 had a recall in 2005 dec. did not hear of the recall till 2007 she did have it removed in 2005 but she died of fustilue fungus in her blood it caused her colan to split she was in hosp. 3weeks waiting to have colan fixed but when the time came she was in intensive care unit @ was having all kinds of problems they put her in intensive care icu, on weds, that fri she was suppose to have surgery she passed on.
HI poohbear913. I am very sorry for the lost of your mother, due to medical errors. I hate to ask you this, but their is a lady named Lor over on North Penn Hernia Institue, that is asking about people that have passed away from complications. I don't know if you would like to post this to her.
Howie

Centreville, VA

#2380 Jul 2, 2009
Can somebody update us if they had a rebound HRT mesh put in?

And yes Restaurant Man on Dr. Goodyear's board. I agree with you about tipping your waitress well if the food and service is good. Not sure if you are on this board or not.

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