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

Full story: PRWeb 8,120
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, ... Full Story
Lucian

Limington, ME

#6153 Jun 23, 2012
I had a mesh patch put for a surgical heronia, now I have several steph infections, this last one is not being treated. They told me to pack it. Not improving. Why does this keep happening? I have had 4 operations since June of 2011, two of them have been for infection.
Thank You
patty

Springfield, OR

#6154 Jun 23, 2012
Lucian wrote:
I had a mesh patch put for a surgical heronia, now I have several steph infections, this last one is not being treated. They told me to pack it. Not improving. Why does this keep happening? I have had 4 operations since June of 2011, two of them have been for infection.
Thank You
The meshes cause infections. 4 surgeries in one year is insane. I dont know how you can take it. Get well!
No Mesh

Carnegie, PA

#6155 Jun 23, 2012
It's not from the ingredients. It's due to the fact that the polypropolene and gore-tex that are on the DAVOL mesh contract at different levels meanining the chance for a recurrance or bowel attachment is very high.
nomeshno

Gilbert, AZ

#6156 Jun 24, 2012
Lucian wrote:
I had a mesh patch put for a surgical heronia, now I have several steph infections, this last one is not being treated. They told me to pack it. Not improving. Why does this keep happening? I have had 4 operations since June of 2011, two of them have been for infection.
Thank You
You need the mesh removed ASAP. Search a real surgeon who can remove the mesh and can suture you properly without using plastic poison in your body. Your body is rejecting the mesh and harbouring the bacterial infection, even IV anti-biotics may not touch the infection.
Rejected Researcher

AOL

#6157 Jun 24, 2012
patty wrote:
<quoted text>You are not out of line, you are dreaming. As long as there is money to be made the FDA wont do anything to protect consumers.
NO Not DREAMING! Just fedup of being SCREWED with, or being jerked around and paying out on insurance payments, more out in SSD, Medicare. Then news saying its going cost you more BAH BAH BAH! Which it wouldn't if the Congress would stop the CROOKS from getting payoffs, the Fruad etc..... start looking at the waste that deffective medical devices are costing the government. ON those that cann't afford insurance. Like those of medical needy, those either on SS SSD SSDI limited income or underpaid..
Carol K

United States

#6158 Jun 24, 2012
Sonya, it sounds like you are receiving the same treatment that most women get because some doctors just want an easy patient and fast money. They must know your problem is from the mesh recall but they are just sweeping you under the rug. Anyone would be depressed if they went through what you are going through. But you don't have "depression" which is a clinical diagnosis. Depression does not cause bleeding and fever. Antibiotics treat infections but why is your infection not clearing up? Because you probably have the mesh that is recalled and it is still injuring your abdomen. Horrible people in the world...so many are neglected by the healthcare community. I am so sorry you are going through so much. My daughter (also 30) was in a horrible car accident caused by a tractor trailer driver with road rage. She suffered for years from heart palpitations, severe headaches, and abdomen pain and the doctors tried to tell her she was depressed and crazy. She finally went to a specialist who tested her and figured out that her brain injury had caused some concussion related brain swelling and had to be treated with a certain medication. Finally she got better, but the trauma of being mistreated by doctors stays with her still, 9 years later.
Sonya wrote:
I have all the same symptoms, blood im my stool at least 3 to 4 times a month. Heart palpitations so my doctor took me off the allergy meds I was on, severe pain in my abdomen, ob/gyn said all's fine. The doctor that did my surgery refuses to see me, because as the nurse put it I was late to one appointment. I called another doctor and the nurse said they can't see me either. My doctor said I have a pulled muscle but the pain feels like it is deeper than that. I cannot work out anymore due to the pain and I am on antibiotics all the time for infections and fever. My doctor said it's stress at work. I quit my job and I am still sick. Some days I can barely get out of bed. Another doctor said that I am depressed. I am not depressed, that much I know. The pain is real and not due to depression. My surgery was in August 2005. I have been sick since. I have no energy and it's not due to my age either. 30 is not old!!!!
patty

Springfield, OR

#6159 Jun 24, 2012
Rejected Researcher wrote:
<quoted text>NO Not DREAMING! Just fedup of being SCREWED with, or being jerked around and paying out on insurance payments, more out in SSD, Medicare. Then news saying its going cost you more BAH BAH BAH! Which it wouldn't if the Congress would stop the CROOKS from getting payoffs, the Fruad etc..... start looking at the waste that deffective medical devices are costing the government. ON those that cann't afford insurance. Like those of medical needy, those either on SS SSD SSDI limited income or underpaid..
I am sorry. I understand how fed up you are with the bullshit. Its not right. We dont have insurance, no ssi, no medical at all. Just sold everything we worked so hard for. Also lost our business because my husband could no longer work. he tried! Now he needs more surgery and another freaking repair! Its that or pain, and probably will be on pills forever!Just like the rest of the people in this forum. But, every single person has their own personal story, they are not the same but unique individuals who have one thing in common, a mesh.
Me again

Mcpherson, KS

#6160 Jun 25, 2012
Rejected Researcher wrote:
me again post#6140. I have tried three different time to type a site in that goes to your posting. yet topix will not post it properly???? so type this in search box FDA 510(k) surgery Mesh. One site I was looking at Vaginal Mesh&FDA 510(k)-Chicago-Land-Injury Board. Then check out this Site. Four Medical Implants That Escape FDA Scrutiny-ProPublica April30,2012
Go to : AboutLawsuits.com or just type the first sentence of that article in search engine. Sign up, everyday is an update. 8}
Me again

Mcpherson, KS

#6161 Jun 25, 2012
New problem I'm seeing double . . .
iris

Seattle, WA

#6162 Jun 25, 2012
to Darla- I had the exact same health problems as you,
the bladder problem you mentioned was the same for me. I
I just had my mesh removed, it had a broken ring and
had bunched up in a ball, it was pushing on my bladder
Now that it is out, i do not have the bladder problems, H
however, i have a new pain from where they had to
cut it out of me, along with alot of tissue and nerves I also get treated like a junkie if
if i go to the ER, so i never go there.get that nasty thing
thing out, and you will probably not have some of the
problems you are having. I had to complain for 8 years
before they took mine out, by then i was in a wheelchair
and on a high dose of pain meds..goodluck!
Renee

Fresno, CA

#6163 Jun 25, 2012
I have had ongoing digestive issues, along with an adhesion, after inguinial hernia mesh repair in 2001 as well as occasional numbness in my leg. Has anyone experienced similar complications as a result of the hernia repair w/mesh?
patty

Springfield, OR

#6164 Jun 25, 2012
Renee wrote:
I have had ongoing digestive issues, along with an adhesion, after inguinial hernia mesh repair in 2001 as well as occasional numbness in my leg. Has anyone experienced similar complications as a result of the hernia repair w/mesh?
Sure, the mesh causes foreign material reactions that can range from infections to auto immune diseases. Digestive health is a biggie. The numbness is maybe due to the mesh cutting off nerves. Im no doctor, just look at other posts. I wish you well, and I hope you can get to the bottom of the issue. Taking good probiotics can increase your digestive health as well as daily fiber supplements. My husband started taking both and they really helped.
donna

Murphysboro, IL

#6166 Jun 25, 2012
did anyone hear from the miller firm trial lawyer
in re:kugel hernia mesh litigation.
lynn

Dallas, TX

#6167 Jun 26, 2012
What kind of mesh patches are being used today for these hernia surgery. Seem like after 2007 the patches produce by another company is better..help with more info if true or false.
All Meshed Up

Montrose, CO

#6168 Jun 27, 2012
Me again wrote:
Trasvaginal Surgical Mesh
Posted: 20 Jun 2012 09:30 AM PDT
A federal judge is allowing the discovery process to resume in the recently consolidated litigation over transvaginal surgical mesh, as new cases continue to be filed by women throughout the United States at a high rate.
All discovery was stayed earlier this year in federal lawsuits filed involving transvaginal mesh products manufactured by American Medical Systems (AMS), Boston Scientific and Ethicon, which were used for surgical repair of pelvic organ prolapse (POP) and female stress urinary incontinence (SUI).
In February 2012, the U.S. Judicial Panel on Multidistrict Litigation centralized the lawsuits as part of three different MDLs (multidistrict litigations), assigning the cases to Chief District Judge Joseph R. Goodwin for coordinated pretrial proceedings in the U.S. District Court for the Western District of West Virginia.
A fourth MDL, involving C.R. Bard trasvaginal mesh lawsuits, was previously assigned to Judge Goodwin in October 2010.
All of the lawsuits involve similar allegations that the manufacturers failed to adequately warn consumers or the medical community about the risk of serious complications after transvaginal mesh surgery, including reports of severe pelvic pain, infections and erosion of the mesh through the vaginal wall.
According to a pretrial order (PDF) issued on June 14, Judge Goodwin has agreed to lift the stay on discovery in the newly formed MDLs, indicating that no party has expressed an objection or shown good cause why discovery can not resume. As a result of the order, the parties can move forward with the exchange of information and evidence necessary to prepare the first cases for trial.
Over the four months since the AMS, Boston Scientific and Ethicon MDLs were formed, the number of lawsuits transferred to Judge Goodwin has increased dramatically.
On February 7, when the first cases were transferred into the newly formed MDLs, there were 80 AMS mesh lawsuits, 21 Boston Scientific mesh lawsuits and 35 Ethicon mesh lawsuits. According to conditional transfer orders filed this month, so far an additional 253 AMS cases, 162 Boston Scientific cases and 218 Ethicon cases have been transferred in to the respective MDLs, and there are no signs that the number of lawsuits is slowing down.
With the Bard transvaginal mesh litigation, which started with 21 lawsuits in October 2010, an additional 390 cases have been transferred into the MDL over the past 20 months.
Public awareness about the risk of the complications from vaginal mesh increased last year, after the FDA issued warnings about an growing number of adverse event reports associated with the products. In July 2011, the FDA issued transvaginal mesh warning, indicating that they have been unable to find any evidence that transvaginal mesh kits used for repair of pelvic organ prolapse provide any benefit over other available means of treatment.
My only comment/prayer for you and all the other women implanted with this crap is that you WILL get compensation, there WILL be public out cry, that there WILL be an independant investigation, that there WILL finally be a beginning of the end of this nightmare and that you WILL be well again. Take Care and Best of Luck.
All Meshed Up

Montrose, CO

#6169 Jun 27, 2012
lynn wrote:
What kind of mesh patches are being used today for these hernia surgery. Seem like after 2007 the patches produce by another company is better..help with more info if true or false.
Go on the net and Google Hernia Mesh Repair or Vaginal Mesh repair and stand by for a shocker....Discounted meshes, meshes from other countries, buy 2 get 3 deals....fun.
Me again

Mcpherson, KS

#6170 Jun 27, 2012
Posted: 27 Jun 2012 08:30 AM PDT

Recently revealed information suggests that Johnson & Johnson not only sold their Ethicon Gynecare Prolift vaginal mesh without obtaining FDA approval, but that the medical device maker also defied an order by the agency not to sell the device once the marketing activities were discovered.

According to a report by Bloomberg News, records exchanged during the discovery process in the Ethicon Gynecare vaginal mesh litigation includes an August 2007 FDA letter to Johnson & Johnson, demanding that the company stop selling the vaginal mesh. However, the company continued to sell the Prolift mesh for another nine months, before the FDA eventually approved the device.

The letter told Johnson & Johnson’s Ethicon unit that it could not market the Gynecare Prolift mesh until it had addressed 16 potential deficiencies and received final approval. The letter came after the FDA discovered that the device was being sold without having gone through even the FDA’s fast track 510(k) approval process.
Gynecare Prolift Vaginal Mesh Introduced in 2005, But Not FDA Approved until 2008

Johnson & Johnson’s Ethicon unit began selling the Prolift mesh in March 2005, but it was not approved by the FDA until May 2008, three years later. The FDA did not discover that the device was on the market until 2007, when the manufacturer asked for approval for a related mesh device, which are both used to provide support for the bladder and other pelvic organs to treat female stress urinary incontinence (SUI) and pelvic organ prolapse (POP).

Despite the indication from the FDA in 2007 that sales of the Ethicon Gynecare vaginal mesh should be stopped, Johnson & Johnson kept selling the device while negotiating with the FDA to obtain approval.

Johnson & Johnson has admitted that it decided on its own that its Gynecare Prolift was substantially equivalent to an earlier vaginal mesh it had marketed. It also decided, on its own, that the device would fall under the auspices of 510(k) approval, but did not actually go to the FDA and get that approval, instead determining that its own judgment was good enough. The company has said that too much is being read into the FDA letter ordering it to stop.
Ethicon Gynecare Vaginal Mesh Linked to Problems, Lawsuits

Earlier this month, Johnson & Johnson indicated that they were planning to “cease commercialization” of the Ethicon Gynecare Prolift mesh and other vaginal mesh products, amid mounting lawsuits and thousands of problems reported by women, including instances where the mesh eroded through the vagina, caused infection, pelvic pain and other complications.

Between the time when the company began illegally selling the mesh and the FDA granting approval in May 2008, there were at least 123 adverse event reports submitted to the FDA in association with the product.

Johnson & Johnson now faces an estimated 1,400 vaginal mesh lawsuits over Ethicon’s Gynecare products, alleging that the company failed to adequately warn women or their doctors about the risk of complications.

Similar lawsuits have been filed against other companies that manufacture surgical mesh for repair of pelvic organ prolapse and stress urinary incontinence, including C.R. Bard, Boston Scientific and American Medical Systems (AMS).

The transvaginal mesh products are designed to help treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI), but in July 2011 the FDA issued a transvaginal mesh warning, indicating that they had received thousands of complaints of injuries and complications, and that they could find no evidence that transvaginal mesh kits used for repair of POP provided any benefit over other available means of treatment.
Me again

Mcpherson, KS

#6171 Jun 27, 2012
They'll pass this on to some crooked lawyers and corrupt judge and nothing will be done as with the rest of mesh cases.
mesh victim

Gilbert, AZ

#6172 Jun 28, 2012
Me again wrote:
They'll pass this on to some crooked lawyers and corrupt judge and nothing will be done as with the rest of mesh cases.
Kathy? I was thinking of you and then I saw your recent posts...
Lory

Hollywood, FL

#6173 Jun 28, 2012
I had double hernia surgery repaired with mesh in 2008. A few days later, I went to the ER, and saw the trauma Dr. that performed the surgery, telling him I felt ripping and burning sansation. He told me it might be the nerves they cut, and gave me Gabapentine. The Medicine did not work! I've been in and out of the hospital ever since with pelvic pain on left side. They always balme it on a small cyst, or sometimes they will hospitalize me for two days, and treat me for pain, but no diagnoses. Now two months ago, I see on TV about the Mesh recall lawsuits. I go on the internet, and what I read is unbelievable!! I am fatigue, joint pain, pelvic pain, which the gyn, tells me is not gynocological. I feel a peircing, pinching,ripping,burning pain on my left side. I just saw a different surgeon, but same hosptial because the surgeon that did the surgery left. The new surgeon blames scar tissue. Son't know what to do..

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