Hernia Mesh Patch Recall - FDA Warns ...

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

There are 8207 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.

Dragonbreath

Kokomo, IN

#5827 May 1, 2012
Blair wrote:
Thanks Lana, As far as hernia mesh, those attorneys made some big mistakes in my opinion. They took a position Composix Mesh was a better alternative than the Kugel Mesh and about 200 cases were kicked out of the litigation in Rhode Island. But I am not an attorney, so that is not a professional opinion. They did the same in the Canadian Class Action with the advice from Motley Rice. Composix Mesh put a lot of Canadians on disability for life. I remenber my surgeon telling me this would be a simple twenty minute operation. He was quick to use my disability insurance and not his. He should of been honest and told me the truth.
Blair, I am just getting into this darkness, researching on behalf of my wife. She just got surgery report back from 2008 says composix type M was used for hernia. My question is composix it's own enity ( company ) and what is the difference between others? Understanding that all or most mesh seem to be not good. Thanks
Me again

Mcpherson, KS

#5828 May 1, 2012
Gynecare TVT Bladder Sling Lawsuit Filed Over Mesh Erosion

Posted: 01 May 2012 08:48 AM PDT

A Maryland couple has filed a product liability lawsuit against Johnson & Johnson, alleging that the wife sustained debilitating injuries as a result of problems with the design of a Gynecare TVT bladder sling used to treat stress urinary incontinence and pelvic organ prolapse.

The complaint (PDF) was filed by Ossie Blackston and her husband, John, in the U.S District Court for the Western District of Missouri on April 27. Johnson & Johnson, as well as their Ethicon and Gynecare subsidiaries are named as defendants.

According to allegations raised in the bladder sling lawsuit, Blackston received a Gynecare TVT mesh sling on May 7, 2009 to treat stress urinary incontinence, uterovaginal prolapse and cystocele. However, after the transvaginal mesh was implanted, she began to suffer persistent pelvic pain, recurrent stress urinary incontinence, as well as infections and bleeding.

A later examination revealed that Blackstonís bladder sling had eroded through her vaginal wall.

On February 18, 2010, less than a year after being implanted with the mesh, she underwent surgery to have the exposed portions removed. As a result, Blackston alleges that she has suffered mental and physical pain and suffering, disability, impairment, loss of enjoyment of life and other problems.

The allegations mirror those contained in hundreds of vaginal mesh and bladder sling lawsuits filed throughout the United States against Johnson & Johnson and other manufacturers. In addition to complaints over Johnson & Johnsonís Ethicon and Gynecare products, similar lawsuits have been filed over Bard Avaulta mesh, Boston Scientific mesh and AMS pelvic mesh.

Plaintiffs allege that the manufacturers failed to adequately research and test their products or warn about the risk of painful and debilitating complications from bladder sling and transvaginal mesh products, such as pelvic pain, infection and vaginal mesh erosion.

The Blackstonís lawsuit will likely be transferred to the U.S. District Court for the Southern District of West Virginia, where the federal bladder sling litigation has been centralized for pretrial proceedings, as part of an MDL, or multidistrict litigation.
Linda

Wylie, TX

#5829 May 1, 2012
tammy s from michigan wrote:
I had complex incisional hernia surgery on August 26, 2010. the surgeon used strattice mesh. and every since the surgery I have abdominal pain. ct scans and xrays show nothing, I do have a bulge in my epigastric region and the surgeon claimed it was just swelled up and it will eventually go down, well it hasnt. i cant stand not knowing what could be done. please help me.
Hi' I've had many stomach surgeries, the last one was for 2 huge stomach hernias. After surgery while I'm still in the hospital I notice a huge hump on my upper left side and showed it to my dr. he said he didnt know what it was. A few months later I showed it to him again an the new one at my pelvic. He said it was a new hernia not the ones that were there before of course had CT scan showed nothing. Now my whole stomach is huge again like before the surgery. I don't trust him. Very upset. Trying to get educated on mesh, he used Srattice mesh? I'm dealing with a lot of pain again. Not sure where to turn, what to believe.
Blair

Montague, Canada

#5830 May 1, 2012
Dragonbreath wrote:
<quoted text> Blair, I am just getting into this darkness, researching on behalf of my wife. She just got surgery report back from 2008 says composix type M was used for hernia. My question is composix it's own enity ( company ) and what is the difference between others? Understanding that all or most mesh seem to be not good. Thanks
Dragonbreath,the first thing you do is go to the medical records department and ask for her operative report which will have the mesh stamped on it that was used in her surgery. It will have a lot number, that is what is used to identfiy the mesh type. Bard/ Davol is the maker of Bard composix mesh (Canadian subsidiary)and Davol is the USA company. Type M tells me it has a ring but lets wait to you get your lot number. Mesh types are M,L,N and if you go to Sue's post # 4031 Feb. 9/2011 you will see a list of recalled meshs. Your wife will need your patience if she is having complications with her composix mesh. Just ask questions and we will try to help. Good luck
Chuck

AOL

#5831 May 1, 2012
All Meshed Up wrote:
<quoted text>Thanks Mucho for the info! I really appreciate it. Problem being I can't get a lawyer to represent me because my ring has not broken. 5 surgeries, the loss of my profession, the removal of my right testicle, the constant pain and infections, the buldge on my right surgical site and its still not enough to get a lawyer to represent me. I am sick of the whole damn thing! Motley Rice are as corrupt as the FDA is blind!I truly do not know what to do now. SSI won't take me because I am too active. I can't get a job because I am on pain meds. When the last company that was going to hire me found out about the surgeries and the Kugel that I still have inside me I was politely told that I was no longer a candidate for the job. So what do I do? Stand in an intersection and beg? I have very few alternatives now. I want to Thank Dr Richard Holmes now of Albuquerque( he "retired" and left Montrose after about 6 of us got sick from Prolene.) for installing the Prolene that crumpled up and started this whole mess. And I would also Thank Dr Steven Sawyer for removing the Prolene and then in some sort of wierd reasoning decided to fill the hole with a Kugel Patch.Neither Dr. ever reported that the mesh they installed had failed. Both are now gone from Montrose Colorado and have left devistating results in their wake.Good riddance and I can only hope that they get a mesh implant of their own.
Got to ask, you said SSI wouldn't take you. Ok how many time have you tryed to get SSI? If once and was deined, Part of the SSDisability red tape/games is you now have to hire SS Attorney. Do you have other medical problems? Cause you do get it if you have multi health issues. Asthma,thyroid, bloodpresure, edema, bladder, water retension , dia rectus, etc.... also depend on type job you held at time of hernia. Been their.
mbushey

Brownwood, TX

#5833 May 1, 2012
All meshed up get less active. If you have any non-healing soft tissue wounds lingering for longer than 6 months that is an automatic qualifier for SSDI. I didn't hire an attorney I wrote my congressman for a congressional inquest and to my utter amazement he wrote SSDI on my behalf.

“United States”

Since: Feb 12

Llano

#5834 May 2, 2012
Dragonbreath, I don't know what your wife is going through but it's probably the same nightmare we've all experienced. Go ahead and file for SSDI now so you can get her claim started. When I first filed I had yet to encounter the worst of the problems from my first hernia repair. My first repair was in 2008 and the mesh used was from a recalled batch.(I have to be vague because I signed the "never say anything bad papers"). I'm not well versed like Blair and some of the others but I think the Kugal Mesh law suits are winding down and the only ones being accepted are the ring break cases. This forum is full of information and excellant links. Reassure your wife that she is not imagining problems and that there is a whole community of men and women who have suffered from a mesh implant.
Chuck

AOL

#5835 May 2, 2012
I just found this may help understand FDA answer to faulty medical devices and what they plain on doing about it. This also might be answer to the lawsuites not grtting any where? Just what I feel. any way here it is. its a pdf 55 page doc. Titled Guidance for Industry and Food and Drug Administration Staff Factors to Consider when making Benefit-Risk Determinations in Medical Device Premarket Approval and De Novo Classifications http://www.fda.gov/downloads/MedicalDevices/D...
Lynn

AOL

#5836 May 2, 2012
Thanks Chuck poster#5835. My judge it doesn't work. Yet lot of information. I went to FDA site and their was a warning box saying there site been changed. I found where they were updating site about the FDA 510(k) program. So I found this site about it. titled Draft Guidance for Industry and Food and Drug Administration Staff The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)] site, http://www.fda.gov/downloads/MedicalDevices/D...
Lynn

AOL

#5837 May 2, 2012
Ok Topix why didn't the site I just typed didn't post the whole site address? again it's http;//www.fda.gov/downloads/M edicalDevices/DeviceRegulation sandGuidance/GuidanceDocuments /UCM28443.pdf
Lynn

AOL

#5838 May 2, 2012
Lynn

AOL

#5839 May 2, 2012
Lynn wrote:
Ok Topix why didn't the site I just typed didn't post the whole site address? again it's http;//www.fda.gov/downloads/M edicalDevices/DeviceRegulation sandGuidance/GuidanceDocuments /UCM28443.pdf
topix will not type or post the site right. ok their is no spaces in the site type it all as one.
All Meshed Up

Montrose, CO

#5840 May 2, 2012
mbushey wrote:
All meshed up get less active. If you have any non-healing soft tissue wounds lingering for longer than 6 months that is an automatic qualifier for SSDI. I didn't hire an attorney I wrote my congressman for a congressional inquest and to my utter amazement he wrote SSDI on my behalf.
Yeah I know. But even with the pain and such I can't lay back and wait for SSI. I have no family and I have to do something to feed myself,right? So how do you go about surviving while the wheels of SSI grind away? Its a catch 22 situation. Damned if I do and damned if I don't. I have applied once and was rejected and I appealed which was just denied. So my next stop will be an SSI lawyer and maybe by the time the determination comes about maybe my ring will have broken! And then I start this whole process over again. After 5 years of this you would think that there would have been more progress on the mesh problem and their would be governmental acknowledgment. But NO! Sorry! Wrong answer! Please call us when you are on deaths door, without hope, money, a home or a chance in hell that their will be some kind of settlement with the mesh manufacturers even with a 2 foot stack of documentation....but I digress! As time goes by my faith in justice fades as does the life I used to know. OK, OK 1-900-WAaaaaa! We are all in this together and I hope for all of our sakes that this to shall pass and a brighter day will be on the horizon. ;>)
mesh victim

Gilbert, AZ

#5841 May 2, 2012
Blair wrote:
For all you women who think they are the only ones with this issue. You are not alone, every day the FDA does not act on these meshs there are more victims north and south of the border.
http://www.ctv.ca/CTVNews/TopStories/20120430...
I have not read anywhere that the mesh only affects only the U.S. population, especially women. Medical meshes are used all around the world, even without clinical data. Canada began using it only because the FDA cleared it.
mbushey

Brownwood, TX

#5842 May 2, 2012
All Meshed Up, my heart goes out to you. My faith in justice, government, the medical profession, and the old puritan work ethic, is gone. I have lost everything material; I am an RN and the profession I once loved I no longer trust because it is run by the insurance industry. Keep filing for SSDI, a 2 foot stack of med. records is good. The more paper work the better. What tortures me tonight is why why why is my incision from the 5th surgery I had at the end of March infected? I had 2 surgeons who hate prophelene mesh of any type perform an Abd. compartment: releasing muscle from my sides to line the front of my abd. wall. They had to use Strattice mesh and I can actually feel an abd. strength for the first time in 4 years so I do not want this infection to compromise this surgery. I read on another forum that patients with Lyme disease have a lot of problems with their hernia surgeries. Does anyone out there have any info on this? Years ago in the early 80's I had a bullseye rash on my leg but that was before Lyme disease was even named so my Family Phys. didn't know what it was. I had a recalled piece of mesh that buckled but then when that was removed I still ended up with infected incisions and draining fistulas. So I don't know what is wrong. Lyme disease is still so poorly recognized when it is in the chronic stage. I'm grabbing at straws. At least I'm alive and still grabbing though. I finally had to sell my home I worked so hard for to avoid forclosure and my move out date is May 18th and I have no where to go. So if there was a 1-800-WAaaaa no. All Meshed Up it's going to be busy because I'm on it. Do keep filing those SSDI papers, write your congressman a factual letter.(keep it short and to the point and do not embellish), hire an attorney to help if you need to. If you do end up in a shelter of some sort remember there are those who've been there and it will help with your case if anything. I know that sounds discouraging but if it comes to that it can be endured. For what it's worth I pray a lot to my Higher Power.
Blair

Charlottetown, Canada

#5843 May 3, 2012
mesh victim wrote:
<quoted text>
I have not read anywhere that the mesh only affects only the U.S. population, especially women. Medical meshes are used all around the world, even without clinical data. Canada began using it only because the FDA cleared it.
Mesh Victim, if you were to go on Topix for the first time and read my post it says FOR ALL WOMEN. My goal on Topix is to try and help new mesh victims. All meshed up could use your help getting disability and making phone calls to law firms for him. Put your time to good use and contact him. We all had to fight for our disability and without connections you will be denied. All meshed up you need help with your paper work. After four trys i went in front of a tribunal and explained the multiple injurys this mesh caused me,i won.Remember the people on the tribunal are on your side and if you show the damage the mesh caused you will win. Not sure if your system is the same as ours but remember i told you i have my appeal papers that will show you how to present your case. Keep your head up.
Fred Amir

Sunnyvale, CA

#5844 May 3, 2012
First let me thank everyone here for sharing your experiences. This was what convinced me not to have mesh repair for my hernia and go for the Desarda repair.

The following is an interview I did about my research with reporter Jane Akre about mesh-free repair.

She made headline when she was fired by Fox News for wanting to report Monsanto Corp's deceptive practices. She is now helping those hurt by mesh at her site Mesh Medical News Desk.

http://meshmedicaldevicenewsdesk.com/featured...

Hope this info helps.

Since: Apr 12

Location hidden

#5845 May 3, 2012
Fred Amir wrote:
First let me thank everyone here for sharing your experiences. This was what convinced me not to have mesh repair for my hernia and go for the Desarda repair.
The following is an interview I did about my research with reporter Jane Akre about mesh-free repair.
She made headline when she was fired by Fox News for wanting to report Monsanto Corp's deceptive practices. She is now helping those hurt by mesh at her site Mesh Medical News Desk.
http://meshmedicaldevicenewsdesk.com/featured...
Hope this info helps.
I just watch the video. Exactly what is happening to my husband> I knew it!!!
All Meshed Up

Montrose, CO

#5846 May 4, 2012
Isn't it amazing that with ALL the evidence and all of our medical records, whether its vaginal, hernia, bladder, Ethicon, Kugel or whatever mesh, that the medical and manufacturering community STILL will not acknowledge or take possesion of this mesh problem? When it all comes down they will blame us before they will even begin to look at where the real problem started. Hope everyone has a great weekend!
mesh victim

Gilbert, AZ

#5847 May 4, 2012
Blair wrote:
<quoted text>
Mesh Victim, if you were to go on Topix for the first time and read my post it says FOR ALL WOMEN. My goal on Topix is to try and help new mesh victims. All meshed up could use your help getting disability and making phone calls to law firms for him. Put your time to good use and contact him. We all had to fight for our disability and without connections you will be denied. All meshed up you need help with your paper work. After four trys i went in front of a tribunal and explained the multiple injurys this mesh caused me,i won.Remember the people on the tribunal are on your side and if you show the damage the mesh caused you will win. Not sure if your system is the same as ours but remember i told you i have my appeal papers that will show you how to present your case. Keep your head up.
I am trying to get disability myself, i was denied twice then hired a lawyer and was denied again and it being appealed now. But i am told deny rate is 80% for appeal as well. It seems unless your deaths door they wont approve, it should also be for people who cant work but im sure because few have abused the aystem, legitimate cases gwt denied as well.
I should write and get much literature about the dangers of mesh products but i dont know why i cant get myself to be more productive. Perhaps my physical health problems have messed up my emotional & mental health. Its so hard to just get out of bed. As im typing this i am in bed using my smart phone. Im interested to find out how you presented your case.

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.

Health Discussions

Title Updated Last By Comments
News Rhode Island move to mandate HPV vaccine in sch... 54 min anothervoice 3
News Bill would ban smoking in all New York hotel rooms 1 hr Cujo 18
News 2015 autism facts, figures, and the progress be... 1 hr AutisticFAGLicence 9
News Playground smokers banned? 1 hr COUGH COUGH HACK OMG 5
Supporting honey bees through education 1 hr environmentlover101 1
News CVS says its ban on cigarette sales has reduced... 13 hr whatever u say 5
News Bill Coon: Helping us know our risk for Type 2 ... 13 hr Mr_D_La_Tuna 1
News Pregnancy Symptoms - 12 Very Early Symptoms of ... (Jun '07) Wed Issy 6,475
More from around the web