Ethicon Suture Recall

[whholmes]

Earlier this year Ethicon "voluntarily" recalled some 1.7 million surgical sutures citing uncertainty that the product is sterile! Every decade it seems J&J has a huge recall involving its dissolving suture line. This recall involves a large number of suture types that are used in general surgery. Already a couple of reports have gone to the FDA reorting infections with suture lots that are covered in the recall. One hopes J&J acts vigorously to keep this product from surgical use.

[eric]

People have been dying and getting maimed from these infected sutures (2.7 million assumed to be used on patients since 1994) This is not a new story, just a lame attempt, a guise to make it look like Ethicon really cares...we're talking 15 years here, and basicaly nothing was done in that period of time. This garbage is still being used in medical facilities today?????? My daughter almost lost a leg due to staph after a simple walk in walk out corrective surgery for her knee.(winter of 2009)
This "Ethicon" story (I love the name) could have been pulled directly from the pages of the 60's sci-fi book 'The Sheep Look Up' by John Brenner.

[Lana Keeton]

Death by bleedout, death from strangulation of the bowels, perforation of the bladder, male infertility, necrotizing fasciitis, inability to urinate, hernias, colostomies...just a few of the complications of the surgical implantation of Synthetic Surgical Mesh.

Synthetic Surgical Mesh is a very dangerous product being surgically implanted in millions of people every year. The manufacturers of these products know they cause serious permanent injury to patients, but continue to sell them as safe and effective.

The complications put patients permanently in the health care system, cost insurance companies millions and millions of dollars and create thousands of medical malpractice lawsuits.

What you won't see are thousands of product liability lawsuits. Why? It is an extremely complicated product most attorneys don't understand.

The First Annual Conference of Truth in Medicine, a patients advocacy organization, will clear up the confusion.

Truth in Medicine Incorporated has already had success by having the FDA issue a Public Health Notification warning of complications from the use of synthetic surgical mesh.

Our First Annual Conference on Sept 25-27, 2009 in Ft Lauderdale brings together an important group of health care decision makers, prominent doctors from major health care facilities, who are participating in the Conference and who support our cause.

Please attend the Conference, "Surviving the Complications of Synthetic Surgical Mesh".

An alliance between yourself and Truth in Medicine will have a major impact bringing about better health care, reducing health care insurance premiums and filing the right product liability lawsuit for the real CULPRIT...SYNTHETIC SURGICAL MESH.

The conference agenda is posted prominently at http://www.truthinmedicine.us.com/ . See 1st Annual Conference 2009 menu tab for all the details. Scroll to the bottom to use PayPal to register.

There is a special session on Sunday morning, September 27, 2009:

Meet the Attorneys!

8:00 – 11:30AM at the Renaissance Ft Lauderdale, FL

Attorneys will be given a "Mesh Education". What it is. What it does. What harm it causes. Why it is inherently defective. How "Mesh" facts can be applied to the law. Why Federal Pre-Emption does not apply to Mesh. Who the experts are. How to get a jump on discovery and save thousands and thousands of dollars...what are the "right" interrogatories...what are the "right" requests for production of documents. How to make Synthetic Surgical Mesh the next mass tort.

Medical Device Manufacturers make billions and billions of dollars of profit annually. They profit while patients suffer debilitating, lifelong complications, doctors careers, reputations and livelihoods are put at serious risk, insurance companies pay out huge sums on medical claims and millions and millions of Americans then are forced to pay higher premiums for health insurance. "Surviving the Complications of Synthetic Surgical Mesh" is a must for any firm seeking the tools to win big when representing their "Mesh" Clients!! A very small investment for huge returns.

The "Meet the Attorney" session is free to Mesh Sufferers.

See you at the Conference!!

[Lana Keeton]

Ethicon's unsterilized Vicryl Sutures are not the only J&J products causing havoc. Their Prolene mesh causes horrible complications even when sterilized.

Death by bleedout, death from strangulation of the bowels, perforation of the bladder, male infertility, necrotizing fasciitis, inability to urinate, hernias, colostomies...just a few of the complications of the surgical implantation of Synthetic Surgical Mesh.

Synthetic Surgical Mesh is a very dangerous product being surgically implanted in millions of people every year. The manufacturers of these products know they cause serious permanent injury to patients, but continue to sell them as safe and effective.

The complications put patients permanently in the health care system, cost insurance companies millions and millions of dollars and create thousands of medical malpractice lawsuits.

What you won't see are thousands of product liability lawsuits. Why? It is an extremely complicated product most attorneys don't understand.

The First Annual Conference of Truth in Medicine, a patients advocacy organization, will clear up the confusion.

Truth in Medicine Incorporated has already had success by having the FDA issue a Public Health Notification warning of complications from the use of synthetic surgical mesh.

Our First Annual Conference on Sept 25-27, 2009 in Ft Lauderdale brings together an important group of health care decision makers, prominent doctors from major health care facilities, who are participating in the Conference and who support our cause.

Please attend the Conference, "Surviving the Complications of Synthetic Surgical Mesh".

An alliance between yourself and Truth in Medicine will have a major impact bringing about better health care, reducing health care insurance premiums and filing the right product liability lawsuit for the real CULPRIT...SYNTHETIC SURGICAL MESH.

The conference agenda is posted prominently at http:// www. truthinmedicine. us. com /. See 1st Annual Conference 2009 menu tab for all the details. Scroll to the bottom to use PayPal to register.

There is a special session on Sunday morning, September 27, 2009:

Meet the Attorneys!

8:00 – 11:30AM at the Renaissance Ft Lauderdale, FL

Attorneys will be given a "Mesh Education". What it is. What it does. What harm it causes. Why it is inherently defective. How "Mesh" facts can be applied to the law. Why Federal Pre-Emption does not apply to Mesh. Who the experts are. How to get a jump on discovery and save thousands and thousands of dollars...what are the "right" interrogatories...what are the "right" requests for production of documents. How to make Synthetic Surgical Mesh the next mass tort.

Medical Device Manufacturers make billions and billions of dollars of profit annually. They profit while patients suffer debilitating, lifelong complications, doctors careers, reputations and livelihoods are put at serious risk, insurance companies pay out huge sums on medical claims and millions and millions of Americans then are forced to pay higher premiums for health insurance. "Surviving the Complications of Synthetic Surgical Mesh" is a must for any firm seeking the tools to win big when representing their "Mesh" Clients!! A very small investment for huge returns.

The "Meet the Attorney" session is free to Mesh Sufferers.

See you at the Conference!!

[wolf 99]

Ms. Lena Keeton,Help!!!!! Friday August 14,2009. Hello, I just found this thread about recall on the sutures by Johnson&Johnson. Do you know what ones are on that recall??? I have not been able to find out. I have had three prior surgeries all in the tension technique. Two C-Sections. In 1982&1987.Then 16 years later a Ventral Hernia, using the Mayo Tension Technique. the defect was closed using Ethibond sutures in interrupted manner. Now since July of 2008, needing new sugery for the recurrence of the Ventral Hernia. My medical records don't show any kind of UPC Code. I belief a hospital code??? Your help would be grateful. Thank You.

[Lamentable]

For suture recall info see http://www.accessdata.fda.gov/scripts/cdrh/cf... and related pages in FDA's Medical Device Re4call section

[Doubtingthomas]

I wish hand washing was mandatory everywhere, not just restaurants. Have you ever watched your doctor when he visits you in the hospital - does he wash after he saw your infected neighbor? Not many do - takes too much time and he gets paid based on volume of patients, not quality time spent. How many times do products get blamed because your doctor doesn't wash his hands or change his gloves? How about the doctors student helper - is he/ she really sterile?

[wolf 99]

Lamentable wrote:

For suture recall info see http://www.accessdata.fda.gov/scripts/cdrh/cf... and related pages in FDA's Medical Device Re4call section

08/14/09 Friday. Hi Lamentable, Hey thanks for the recall FDA/MAUDE site. I aready have it. My problem is that, the surgery report that list all product codes is missing. I just got off the phone with the hospital back in Florida where the surgery was done. and the only thing I have is the patient and Op report. and the Op report has listed that ethibond sutures were used and the hospital code, which hospital says is to old to be cross reference over. Then the surgeon will not help. This surgery was a county indigent care emergency surgery. I had to quit work, with no health insurance, so had to be picked up with county help.

[Lana Keeton]

Doubtingthomas wrote:

I wish hand washing was mandatory everywhere, not just restaurants. Have you ever watched your doctor when he visits you in the hospital - does he wash after he saw your infected neighbor? Not many do - takes too much time and he gets paid based on volume of patients, not quality time spent. How many times do products get blamed because your doctor doesn't wash his hands or change his gloves? How about the doctors student helper - is he/ she really sterile?

Dear Doubtingthomas, You must work for J&J. Changing the subject...typical of J&J's borderline criminal activity....

quoted from Ethisphere. com....
Perhaps no problem faced by J & J was potentially more damaging than a death on April 2, 2004.
On that day, Zakiya Kennedy, an 18-year-old who dreamed of being a model, was waiting for a subway on the 42nd Street platform in midtown Manhattan when she fell down. After getting up, she approached a policeman complaining of a headache and leg pains. Within seconds the Berkeley College freshman collapsed
and died.

The tabloids of the nation’s largest city were ready to pounce on the story. At first the story was that she died due to being pushed by her boyfriend— who was quickly vilified.

However, the story took a less interesting turn when an autopsy revealed the cause of death was a blood clot, a pulmonary embolism, which is extremely rare in healthy 18 year-olds.

Later it was learned that the teenager had recently started using the Ortho Evra birth control patch manufactured by Ortho-McNeil Pharmaceutical division of J & J. The teenager’s family began to speak out against the company, and soon a confidentially agreement and financial settlement was reached with them. At that point the story largely disappeared from public view

Yet this death was important as a tip of the proverbial iceberg—with persistent questions beginning to arise about potential misconduct by Johnson & Johnson around the design, launch and marketing of Ortho Evra patches.

As of December 31, 2006 more than 1,500 claimants were pursuing J & J over Ortho Evra. Claimants include a Texas woman paralyzed by a stroke just 12 days after initial use and the families of a 25-year-old mother of two who died of a heart attack after six weeks on the patch; a 14-year-old girl who died from a blood clot in her lower pelvis after just eight weeks; and a 25-year-old mother of three who died from a brain blood clot after two weeks on the patch.

If future researchers establish a link between Ortho Evra’s high doses of estrogen and increased rates of breast cancer, J & J would be headed into a financial and PR storm. But that’s the future. J & J is dealing with the here and now.
In the Internet age, news travels fast. Recognizing that, J & J designed a comprehensive online marketing campaign allegedly intended to make negative information on Ortho Evra harder to find.

According to internal documents unsealed by a New Jersey Superior Court this spring (over J & J protestations), the company was in the process of buying (or planning to buy) all the top keyword positions for related searches online, as well as intending to create an “unbranded website” seemingly unaffiliated with J & J. With “search engine optimization” strategies, J & J hoped to have this unbranded website show up as second most popular behind the official Ortho Evra site, thereby covertly getting its message out.
J & J also bought approximately 100 dubious URL names such as: deathpatch. com, badevra. com, the Patchkills .com, ThePatchTruth .org; and patchsucks. com.

[wolf 99]

Not to change the topic. Why isn't anything being done, as to why so many defective products are on the market. Who watches over the FDA to make sure products are safe before being patent. How long are different products checked for side efects, rather it be medical device or medical drugs tested for defects or side effects before marketing..It just seems any more, you turn TV on and their is a recall or law suit for defective products.. With this being said, is not this not part of why our heaalth care is in the shambles it's in??? Just like all this hernia mesh and how people are becoming disabled from it.

[Lana Keeton]

wolf 99 wrote:

Not to change the topic. Why isn't anything being done, as to why so many defective products are on the market. Who watches over the FDA to make sure products are safe before being patent. How long are different products checked for side efects, rather it be medical device or medical drugs tested for defects or side effects before marketing..It just seems any more, you turn TV on and their is a recall or law suit for defective products.. With this being said, is not this not part of why our heaalth care is in the shambles it's in??? Just like all this hernia mesh and how people are becoming disabled from it.

Dear Wolf 99,

Synthetic Surgical Mesh is "approved" through the FDA's 510 (k) Pre-Market Notification submission process.

NO HUMAN CLINICAL TRIALS ARE REQUIRED.

NO PROOF OF THE SAFETY OR EFFICACY (THAT IT WORKS) ARE REQUIRED.

They simply state the product is 'SUBSTANTIALLY EQUIVALENT" to a product being sold before the 1976 Medical Device Amendment Act.

The FDA's Pre-market Approval process requires a lengthy process.

Normally it takes the FDA 20 hours of time spent by employees to approve a 510 (k) PMN product...the Pre-Market Approval (PMA) process takes 1200 hours of their time.

AMERICANS DO NOT KNOW THIS INEQUALITY OF APPROVAL EXISTS.

We all believe "FDA Approved" means it is safe.

IT DOES NOT!

There is no differentiation on packaging at any level anywhere which shows if the product has been approve through the PMN or the PMA process.

SUTURES ARE THE PRODUCT MESH IS SUPPOSED TO BE "SUBSTANTIALLY EQUIVALENT" TO. RIDICULOUS TO ME!

WE ARE ALL HUMAN GUINEA PIGS!

THE FDA PROCESS NEEDS TO BE CHANGED...NOT THE WHOLE HEALTH CARE SYSTEM!

Hope this clears it up for you...God bless, Lana

p.s. write to me at truthinmedicine @ bellsouth. net to join Medical Mesh, a yahoo health group where patients help patients to find solutions...

[wolf 99]

Lana Keeton wrote:

<quoted text>
Dear Wolf 99,
Synthetic Surgical Mesh is "approved" through the FDA's 510 (k) Pre-Market Notification submission process.
NO HUMAN CLINICAL TRIALS ARE REQUIRED.
NO PROOF OF THE SAFETY OR EFFICACY (THAT IT WORKS) ARE REQUIRED.
They simply state the product is 'SUBSTANTIALLY EQUIVALENT" to a product being sold before the 1976 Medical Device Amendment Act.
The FDA's Pre-market Approval process requires a lengthy process.
Normally it takes the FDA 20 hours of time spent by employees to approve a 510 (k) PMN product...the Pre-Market Approval (PMA) process takes 1200 hours of their time.
AMERICANS DO NOT KNOW THIS INEQUALITY OF APPROVAL EXISTS.
We all believe "FDA Approved" means it is safe.
IT DOES NOT!
There is no differentiation on packaging at any level anywhere which shows if the product has been approve through the PMN or the PMA process.
SUTURES ARE THE PRODUCT MESH IS SUPPOSED TO BE "SUBSTANTIALLY EQUIVALENT" TO. RIDICULOUS TO ME!
WE ARE ALL HUMAN GUINEA PIGS!
THE FDA PROCESS NEEDS TO BE CHANGED...NOT THE WHOLE HEALTH CARE SYSTEM!
Hope this clears it up for you...God bless, Lana
p.s. write to me at truthinmedicine @ bellsouth. net to join Medical Mesh, a yahoo health group where patients help patients to find solutions...

Sunday08/16/09.2:36pm c-time. Dera Lana Keeton. Thank you for your timeand kindly your answers. The more I read and researsh about meshes and sutures the scarier it gets.. I don't have mesh in me at this time. First Ventral Hernia was with entrapment in 2003. Repaired with tension technique of Mayo vest over pants.Their is 2 prior c-sections , Which on one hand I don't have the mesh problems. but yet I have recurrence of the Ventral Hernia. In researching this morning, I found this tid bit of hernia cost. This was dated: 10/14/2008 Ventral Hernia Repair marked to grow to over $800 million in 2013. This was on the Bio-Medicine. Now you tell me who's making the buck's?????? This was dated 10/2008. Isn't that something. web site: www.bio.medicine.org/medicine-news-1/Ventral-...

[wolf 99]

http://www.bio-medicine.org/medicine-news-1/V...

[Lora]

I just read your post. I am looking for people affected by the recalled sutures. If you go to fda. you will find info. I learned earlier if you read the left side click where it will let you search by company. Ethicon has a ton of recalls but you won't find them unless you go through the company name.If you have problems from recalled sutures I would love to hear from you.

wolf 99 wrote:

Ms. Lena Keeton,Help!!!!! Friday August 14,2009. Hello, I just found this thread about recall on the sutures by Johnson&Johnson. Do you know what ones are on that recall??? I have not been able to find out. I have had three prior surgeries all in the tension technique. Two C-Sections. In 1982&1987.Then 16 years later a Ventral Hernia, using the Mayo Tension Technique. the defect was closed using Ethibond sutures in interrupted manner. Now since July of 2008, needing new sugery for the recurrence of the Ventral Hernia. My medical records don't show any kind of UPC Code. I belief a hospital code??? Your help would be grateful. Thank You.

[Jaye]

I don't know if my sutures are on the recall list but I am having a hell of a time with them. It's been almost 2 years and they are still passing thru my flesh, causing infection and bleeding. I was told they were supposed to dissolve but apparently they aren't. Lora it says you're in Denver, me too.

[Lora]

If you want to email me about this I can share with you more of what is going on. You are about to run out of time legally my email is [e-mail] Hope to here from you soon;
Thank's Lora

Jaye wrote:

I don't know if my sutures are on the recall list but I am having a hell of a time with them. It's been almost 2 years and they are still passing thru my flesh, causing infection and bleeding. I was told they were supposed to dissolve but apparently they aren't. Lora it says you're in Denver, me too.

[Lora]

I am still learning the system of Topix.
I added to yours. I asked you to email me.
The email is jgreen [e-mail]. Thank you,
lora

[Jaye]

Lora, I sent. Please check your junk mail :)

Lora wrote:

I am still learning the system of Topix.
I added to yours. I asked you to email me.
The email is jgreen [e-mail]. Thank you,
lora