FDA Recall All Synthetic Surgical Mes...

FDA Recall All Synthetic Surgical Meshes Hernia, Bladder, Pelvic Prolene by J&J

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Suzanne

United States

#2 Sep 7, 2008
Lana,

First and foremost, we have got to get all the Truth in Medicine members, if they haven't done so already, to file an adverse event report with the FDA. The more cases that are documented, the better our chances of accomplishment.

I am behind you all the way. I have a tremendous respect for you, and will do my part to assure that we are successful in our endeavor to get surgical meshes pulled from the market.

No more people should be hurt by these vicious apparatuses than have already been. There are millions of us who have had these surgeries, and it seems like the adverse events are just beginning to be exposed; its the tip of the proverbial iceberg. I think Ethicon is sitting on a powder keg, as I have become aware of others besides myself in this tiny little town I live in who are suffering consequences similar to mine. I imagine, in the metropolis areas, it is bursting at the seams, and we just don't know about them, YET.

I will be with you in spirit in Nashville. Please video record the meeting, so that those who can't come will still be able to be a part of it.

Keep up the great work!! Let me know if there is anything else I can be doing to help, more so than what you and I both know I am trying to accomplish.

Friends and allies,

Suzanne
Deborah

United States

#3 Sep 8, 2008
We are in the beginning stages of blowing the roof off these horrendous practices and inappropriate mesh devices that Ethicon has exposed us to. WE ARE VICTIMS of their greed and we refuse to be SILENT VICTIMS. We have been robbed of our 'healthy' lives and income potential. Our children and grandchildren have been robbed of our attentions. The drs have been hood-winked and rather than own up to the deceipt and the horrors of this lack of judgement and the greivous outcomes; instead of further educating themselves on how to best remove these caustic materials...they choose to conduct that other age-old practice of using CYA tactics. However, I can't help but believe that with continuous efforts, lots of work and daily prayer we will blow this 'powder keg' right out of the water and expose the greed and total lack of respect for human beings by the pharmacuedical companies and the very real fear of our own government officials, such as the FDA, who are there to serve and protect the citizens of the US, regardless of their political standing or wealth. Thanks to all who contribute their time and efforts to enlighten the public-at-large of these on-going injustices.

Deborah
Suzanne

Mississippi State, MS

#6 Sep 16, 2008
I find the post that came through from Taylor Steel despicable. What was written had absolutely nothing to do with surgical mesh, or its removal from the market. Why one would want to attack a person like Lana, who is trying to do so much good on behalf of so many is beyond me.

Maybe, if you would focus your energies in the right direction, we might actually succeed in getting surgical mesh off the market. But then again, don't worry, we will succeed without you.

Please, focus on the task at hand, and keep your petty grievances to yourself!

“God Loves You!”

Since: Sep 08

Miami Beach, Florida

#7 Sep 18, 2008
PLEASE JOIN THE MEMBERS OF TRUTH IN MEDICINE IN THEIR FIGHT AT THE FDA TO HAVE ALL SYNTHETIC SURGICAL MESHES RECALLED BY THE FDA!!!

The devastating complications and deaths by synthetic surgical mesh have to be stopped!

THE FIGHT IS ONGOING BUT THE MEETING WILL BE RE-SCHEDULED!!

THERE IS NO MEETING ON SATURDAY, SEPTEMBER 20,2008 IN NASHVILLE, Tn FOR TRUTH IN MEDICINE!

STAY TUNED FOR THE NEW DATE!!!!

peace and many blessings, Lana
Deborah Benfield

Jacksonville, FL

#8 Oct 3, 2008
In 2004 I had a hysterectomy, and the Dr put a mesh supporter under my bladder. I have not been able to have sex as it is very painful even when I have an exam,and it bites my partner. When I sit down sometimes it pinches. I would like to be included in any upcoming meeting. I also would like to know what I can do to get in on this class action suite.
Anonymous

Browns Mills, NJ

#9 Oct 8, 2008
Suzanne

United States

#10 Oct 15, 2008
We have another mole!
Anonymous

Browns Mills, NJ

#11 Oct 18, 2008
who do you feel the mole is? we all need to help one another to get thru this and to get these products pulled off the market.
Suzanne

United States

#12 Oct 19, 2008
Actually, the mole posted on the Injured by Ethicon's Prolene Hernia/Bladder Mesh site. His name is John Doe from Greenville, PA and he states:

"I am so sorry for your bad outcomes. Unfortunately these are potential outcomes. With mesh exposure being approximatley being less than 2-3 % of the population. Normally these risks are or should be reviewed prior to the surgery. As far as the lasy saying TVT, unfortunatly TVT has become like Kleenex and Xerox, Many company's out there have a TVT. You mentioned the TVT also had a piece of wire in it> That is not Gynecares TVT that is another company. Your issues are more with your Dr not with the product. You're looking for a class action because you think it will result in more money."

What he wrote is offensive to me, as I am sure it is to the many others who have been harmed and had their lives disrupted by surgical mesh products. I responded to him. Please go to that mesh website for my response, as it is detailed.

http://www.topix.com/forum/com/jnj/TVQK8627JB...

I wanted to make sure that you were all aware of this post as well. Mr. John Doe didn't even have the cajones to use his real name.

Pathetic really!

Suzanne

Mississippi State, MS

#13 Oct 21, 2008
This went out to doctors today!

MedWatch - The FDA Safety Information and Adverse Event Reporting Program

Transvaginal Placement of Surgical Mesh

Audience: Hospital surgical staff, OB/GYN physicians, other healthcare professionals

FDA informed healthcare professionals of serious complications associated with transvaginal placement of surgical mesh in repair of pelvic organ prolapse (POP) and stress urinary incontinence (SUI). Over the past three years, FDA has received over 1,000 reports from nine surgical mesh manufacturers of complications that were associated with surgical mesh devices used to repair POP and SUI. The most frequent complications included erosion through vaginal epithelium, infection, pain, urinary problems, and recurrence of prolapse and/or incontinence. There were also reports of bowel, bladder, and blood vessel perforation during insertion. In some cases, vaginal scarring and mesh erosion led to a significant decrease in patient quality of life due to discomfort and pain, including dyspareunia. FDA provided recommended actions for both physicians and patients to reduce the risks.

Read the entire 2008 MedWatch Safety Summary, including a link to the FDA Public Health Notification regarding the above issue at: http://www.fda.gov/medwatch/safety/2008/safet ...
Suzanne

Mississippi State, MS

#14 Oct 30, 2008
Hi All,

Here is the link to a lawfirm who is taking mesh cases. Hallelujah, someone is finally taking our situation seriously!

http://www.schmidtandclark.com/Transvaginal-M...

Schmidt & Clark | A National Law Firm
1001 Pennsylvania Avenue NW
6th Floor South
Washington D.C. 20004

Schmidt & Clark | Dallas
2911 Turtle Creek Blvd
Suite 1400
Dallas, Texas 75219

Maybe now, we can find a lawfirm to assist us in holding the manufacturer accountable for what has happened to us. I don't think this firm is able to help those outside the United States, but you may want to consider contacting them for a referral.
Suzanne

Montgomery, AL

#16 Apr 10, 2009
Not sure if I am allowed to post a link from topix, but if not I guess it will be deleted.

http://www.topix.com/forum/com/jnj/TTE0RAIRMP ...
Cindy

United States

#17 Aug 7, 2009
I have had 3 hernia surgeries the last one i had in 3/20/03 they took out my belly button and put a Prolene pop-offs was inserted, I have pain in that area still, sometimes it fills as it its coming thru the skin...Is there a recall on this? or is there any info on this type of mesh
Suzanne McClain

Starkville, MS

#19 Oct 5, 2009
Cindy wrote:
I have had 3 hernia surgeries the last one i had in 3/20/03 they took out my belly button and put a Prolene pop-offs was inserted, I have pain in that area still, sometimes it fills as it its coming thru the skin...Is there a recall on this? or is there any info on this type of mesh
Cindy,

I have never heard of Prolene Popoffs. Is this the actual name? If you can provide more information, I will be happy to help you research it.

Post more info, and I will look into it.

Best,

Suzanne
Coco

Los Angeles, CA

#20 Oct 14, 2009
Please advise if anyone has had problems with the
12 x 12" Ethicon Prolene Patch. It was used to "repair" an umbillical hernia in May, 2003.

My experience was nothing short of catastrophic and continues to alter my life in a devastating way.

If someone out there knows of someone who had problems as a result of this specific product, I
would very much like to talk to you.

Thank you,

Coco
Suzanne McClain

Decatur, MS

#21 Dec 27, 2009
Hi Folks,

Please sign the petition "The Danger of Surgical Mesh and the Push to Have It Removed From the Market" on the Care2 Petition Site.

Type my name, Suzanne McClain in the search box and click on care2 search.

I will forward this petition to Congress and the FDA once we have reached the specified number of signatures.

Thank you,

Suzanne
tony

Saint Petersburg, FL

#22 Jan 5, 2010
Had synthetic mesh put in in the mid 1980's. Now 23 years later I have to have major surgery to have mesh removed..

How do I find out what type was used and do I have any recourse?

thanks
Suzanne McClain

Decatur, MS

#23 Jan 5, 2010
Tony,

You may still be able to get a copy of your hospital records from the initial surgery. My guess is the records have long ago been archived, but for a fee, and with some patience the hospital may be able to provide a copy to you. The exact mesh should be listed on your hospital records.

The Statute of Limitations in Florida is as follows:

4 years Strict Products Liability
4 years Negligence
4 years Personal Injury
2 years Malpractice

I would then suggest, if it has been less than four years since you discovered you had a problem, that you contact an attorney for advice. There are a few firms handling mesh cases, and they may be able to assist you. I can provide you the names of a couple firms if you'd like. Just email me at: [email protected]

Good luck with your extraction surgery.

Best,

Suzanne

Jessie

United States

#25 Jan 25, 2010
well on july 29th of this year i had vaginal mesh put in for prolapse i am 29 years old and had to have historectomy for the problems ive been having, now i've been to the doc 6 times since the surgery for mesh poking thru the skin, this was not the origianl plan but i was asked about doing this the morning i was going in to prep for the surgery and thought sure i can handle it after all he is my doc i have trusted and still do i dont belive this to be his fault but the makers of the mesh who i belive is more worried about money in their pocket rather than the well being of the people
Suzanne McClain

Decatur, MS

#26 Jan 25, 2010
Hi Jessie,

I am sorry to hear of yet another mesh victim. Mesh is a dangerous product to have in the body. For many it erodes away tissue like a cheese grater, allowing it to become exposed in the vaginal vault, for others, it adheres to their organs and/or nerve beds.

You need to see a urogynecologist right away.

I have researched several mesh products, and have tied their approval through the FDA back to a mesh product that its own manufacturer pulled from the market in 1999, stating that their product "did not function as intended and caused a higher rate of erosion and dihescience than expected."

I can help you to research the type of mesh in you, but I would need to know the type of mesh implanted in you. You can find out the exact type from your hospital records, and the hospital cannot deny you a copy of the records, though they may charge a small fee. After you obtain these, it is important that you file an adverse event with the FDA on form 3500. I too can help you with this.

You are right to blame the manufacturer, but you must open your eyes to see that it may also be the fault of the doctor too. If your doctor, prior to surgery did not make you aware of the many complications that can arise from the use of mesh products, than he/she is also at fault to some degree. Many doctors, not all receive kickbacks from pharmaceutical companies to promote their products; I'm not saying yours did, just that it is a possibility.

If you want my help, email me at: [email protected]

I have helped many, and would be happy to help you as well. This is a very long roller coaster ride, and it helps to talk to someone who has already been down the road you are on.

Please go to the care2 petition site, and sign the petition "Demand Justice for Surgical Mesh Victims"

Also, check out the other mesh blog on topix, where there are over 1200 comments, mostly from mesh sufferers like your self. http://www.topix.com/forum/com/jnj/TTE0RAIRMP...

best,

Suzanne

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