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Vaginal Mesh & FDA 510(k): Copycat Killers and the Dangers Within the System
The FDA has allowed the manufacturers of polypropelene transvaginal mesh and other devices to enter the US marketplace with very few safety checks. Congress is taking some important steps toward changing this system, but, it is important to remember that the manufacturers of these devices are in the best position to warn the public of known dangers and they should be held accountable when their silence leads to people being injured.
The 510(k) Process
Medical Devices come into the market place through one of two premarket processes. One method is to undergo the Premarket Approval process, including clinical trials in humans and demonstrations of safety and efficacy. This process typically only applies to “risky” devices and is not used very often.
The more common path a device will take is through the Premarket Notification process, more informally known as 510(k) clearance. Most devices are cleared through 510(k) because the FDA is required to review devices through the least burdensome means.
The FDA does not require 510(k) devices to undergo clinical testing to demonstrate safety or effectiveness prior to clearing the devices for sale. Instead the device manufacturer must only show that the device is “substantially equivalent” in safety and efficacy to another previously approved device or standard recognized by the FDA, also known as a “predicate device”.
In order to be eligible for clearance, the new device must exhibit roughly the same safety and effectiveness characteristics as the predicate device. That means the device must have the same intended use and technological characteristics as the cited predicate, and that the device poses no new safety or efficacy concerns.
Critics of the 510(k) clearance process point out that it doesn’t require devices to be shown effective in human populations and such devices can pose great danger to the unsuspecting American public as a result.
What is striking about the “substantially equivalent” standard is that a device can be found “substantially equivalent” to a device that is no longer on the market as well as a device that has been recalled from the market for its adverse effects in patients. So long as the FDA has not issued a mandatory recall of the device, it remains eligible to qualify as a “substantially equivalent” predicate device. It should be noted that mandatory recalls occur very rarely – a manufacturer must fail to voluntarily remove a dangerous product from the market.
It is not uncommon for a recalled and dangerous device to serve as the predicate devices for hundreds of other new devices. The FDA is required by law to clear all devices found to be “substantially equivalent” to their predicates, regardless of safety and efficacy concerns.
Transvaginal Mesh – The CopyCat Killer
The scope and severity of injuries caused by transvaginal mesh implants have made this device a prominent example of the dangers of 510(k) premarket clearance.
In his report, Defective Devices, Destroyed Lives, Congressman Edward Markey points to the “predicate lineage” of many vaginal mesh products currently on the market as the cause for their dangerous characteristics. A number of mesh products produced by both Boston Scientific and Ethicon (a subsidiary of Johnson and Johnson) are currently marketing mesh products found to be “substantially equivalent” to Boston Scientific’s ProteGen.
ProteGen was recalled in 1999 after hundreds of women reported experiencing severe pain, infections, and complications. Many of the women suffering today as a result of vaginal mesh could have been saved the pain and discomfort they are experiencing if the FDA clearance procedure was more stringent regarding substantial equivalency or if the manufacturers had warned of the dangers.
Congressman Mackey and his fellow supporters seek to make the FDA device clearance process more stringent, and thereby make the devices on the market safer for the public. At the end of this month Congress will vote on the Safety of Untested and New Devices (SOUND) Act, H. R. 3847. SOUND seeks to improve the safety and efficacy of medical devices by giving the FDA the ability to reject a device based on a predicate that has been recalled. It further requires companies to inform the FDA if products in a device’s lineage have caused harm and instructs the FDA to create a database of dangerous devices so that manufacturers can determine what an acceptable predicate device is. And lastly the bill calls for the FDA to review high-risk devices if a product in their lineages has been recalled. So far, the bill has yet to gain any Republican support and seems unlikely to pass.
Whether the SOUND Act passes or not, it is imperative that the FDA revamp is clearance processes for medical devices as people are loosing their lives everyday. There have been more than 7 confirmed deaths related to vaginal mesh alone. Congressman Mackey points out that the “FDA must have the flexibility to reject devices like mesh that are based on recalled products. These deadly devices are copycat killers.”
We completely agree with the SOUND Act and commend the work of Congressman Mackey. However, we believe that the safety of the American public requires that the manufacturers also be held accountable for placing dangerous devices on the market.
It is important to remember that the manufacturers of the mesh kits are in the best position to warn the public of complications on a timely basis. The FDA estimates that 300,000 women undergo surgeries using vaginal mesh on an annual basis – timely warnings are necessary so that women facing surgery are given all information necessary to make important decisions about their health and safety.

Vaginal mesh helpline 1 877 522-2123

Vaginal Mesh Helpline can finally report some comments from the medical community on the Vaginal mesh complications. Vaginal mesh helpline Listens to women every day with horror stories of the Vaginal Mesh. Vaginal mesh lawsuits are being filed nationwide in  Vaginal mesh multi district lawsuits

FDA warning on mesh held little surprise for urologists
Publish date: Jan 1, 2012
By:  Karen Nash
Karen Nash
Last summer, the FDA issued a strong warning about the dangers of complications from using mesh for the repair of pelvic organ prolapse and treatment of stress urinary incontinence. Between 2008 and 2010, the FDA said it received more a than 2,800 reports of complications associated with surgical mesh devices, generally placed transvaginally, when used for these indications.

The agency urged physicians to be thoroughly trained, to watch carefully for complications, and to make sure their patients are fully informed about procedures and their risks. In September, an FDA advisory panel concluded that the clinical benefits of using transvaginal mesh for prolapse repair have not been proven, but that available data support the safety and efficacy of first-generation suburethral slings for treating stress incontinence.

Urology Times wanted to know if urologists have changed their approach to prolapse and stress incontinence treatment as a result of the FDA's statement. Urologists say they aren't surprised at the warning, and it hasn't affected what they do, either because they weren't using mesh in the first place or because mesh can be used safely in the hands of the right surgeon.

Brian Cohen, MD, in Asheville, NC, has never used synthetic mesh for prolapse repairs.

Dr. Cohen
"I use all absorbable products, some Vicryl mesh, and Tutoplast by Coloplast, a product which is cadaveric fascia lata," Dr. Cohen said. "That's the way I learned in my residency and fellowship, and I've had good results. You don't have the worries you have with a synthetic mesh. I've seen plenty of patients with dyspareunia afterwards. There's no way to really deal with it."

In practice for 4 years, Dr. Cohen doesn't think the mesh should be banned, but he does think the risks outweigh the potential benefits.

"I just had an 85-year-old woman who had a prolapse repaired five years ago. I had to do a partial cystectomy in order to get the mesh out of her bladder," he said. "I take care of the problems; I'm not interested in causing them."

In Mammoth Lakes, CA, Tomi Bortolazzo, MD, agrees with that sentiment.

Dr. Aspera
"The FDA warnings haven't affected me," Dr. Bortolazzo said. "I work in a rural setting now, but when I worked downtown, I used to take care of all the complications from the gynecologists and other doctors doing all the TVTs with mesh. I even had a young, healthy patient spit mesh from her vagina. A lot of people just don't seem to react well to mesh, so now I use a Mylar sling that has pigskin."

Dr. Bortolazzo, a practitioner for 17 years, says she didn't like what she was seeing with the mesh long before the FDA came out with its statements, so she decided to avoid what she thought would be problems down the road.

"Now, I live in an area where everyone is an athlete and active. People don't like to put something foreign in their bodies," Dr. Bortolazzo said. "So I've been doing more and more autologous slings over the last 10 years."

Dr. Goldman
Although both Dr. Bortolazzo and Dr. Cohen are experienced with the complications, neither thinks the mesh should be banned.

"I'm sure there are places for it, perhaps in an older woman who is not sexually sexually active," Dr. Cohen said. "You'll get a longer-lasting repair."

"There are pros and cons," Dr. Bortolazzo added. "I occasionally use it, but I just don't think it's the best thing."

Other doctors question whether the problem is the mesh, as much as it might be surgical techniques or patient selection.

Vaginal mesh helpline Florida and Florida vaginal mesh lawyers is sharing new stories from women with vaginal mesh complications in Florida. To file your vaginal mesh lawsuit call us today. Do not wait. Women must stand up against these manufacturers who ruined their lives woth a vaginal mesh.

Diane and Paula have similar stories about vaginal mesh  they both had TVM implanted for incontinence and they are still experiencing "issues." They aren't suffering the agony of eroded mesh like so many other women, but they believe it's just a matter of time. And both women want to warn others not to have incontinence or pelvic organ prolapse treated with a transvaginal mesh surgical procedure.

"I was having a lot of incontinence problems starting in my 30s," says Diane (not her real name). "When I exercised or coughed I would have a little leakage and it got to the point where I had to wear pads or even change my underwear. So on my gynecologist's advice, I had a transvaginal mesh implant when I was 56, two years ago."

Diane had the surgery at the University of Florida Medical Center, where they specialize in these issues. She was sent home that same day (surgery is on an outpatient basis) and immediately noticed some leakage around her catheter.

"As soon as the catheter came out I had the same incontinence problems so obviously the procedure was a failure," says Diane, "and there is still an issue when I sneeze, even after having another surgery last May, with a different kind of mesh."

But the issue of greater concern for Diane is whether or not the mesh will eventually erode. After reading online and watching on TV about so many women with horrific TVM experiences, it goes without saying that anyone with this mesh would be worried.

"Although I am concerned, there is nothing I can do about it," Diane says. "Besides, there are enough things in life to worry about, so if it becomes an issue then I will do something about it." However, she did file a complaint with an attorney for two reasons: she had to go through a second surgery, and she believes the TVM manufacturers should take responsibility.

"I am lucky that I am not having serious problems, but this mesh could still erode…"

Paula had a hysterectomy and soon afterward, she would have a "little leakage" every time she coughed or laughed. About five months ago her gynecologist of seven years asked Paula if she wanted her problem fixed. So she had the TVM implant at the outpatient clinic.

"Now my problem is worse," says Paula. "When I try to urinate, I push and it's like my bladder locks up. I have to completely relax and it takes so long; sometimes I have to get up and walk around, and sometimes I have to pee about 10 times."

Like Diane, Paula came home after surgery with a catheter and it was removed three weeks later. "What will happen when I am 60 or 70 and I can't go at all, will I have to wear a catheter permanently?" Just before having the surgery Paula heard about transvaginal mesh erosion horror stories, and she expressed concern to her gynecologist. "He said I didn't have to worry about it and to trust him because I was getting a newer model of mesh, the size of a band-aid.

"Now I can laugh and cough without worry; I'm not going to lie and say I have other problems going on, but this problem I have now is not natural and I don't know whether I should have this mesh removed. I do know that, given the information I have about transvaginal mesh since my surgery, I would never have had it in the first place."

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