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Transvaginal Mesh ,Prolapse Mesh, New News

Written by Auto Accident. Posted in Accidents Injuries Wrongful Death

As of September 30th The Transvaginal Mesh Helpline Continues to receive calls Daily from women across the counrtry with Prolapse mesh failure horror stories. On August 25th the consumer advocacy group Public Citizen filed a petition (PDF) with the FDA, calling on the FDA to issue a vaginal mesh recall and ban the marketing of all currently available products to protect female consumers. Just theis week the vaginal mesh helpline received a call from a women whose physician was still suggesting she undergo surgery to have and implanted vaginal mesh.  Yet, the stories continue from all ages and all walks of life. We are receiving calls as far away As Canada and the U.K..  The stories seem to include all the same symptoms:pain, usually in the abdomen and up the leg,increased incontinence,use of a catheter in order to urinate, inabilty to sit, drive a car or have sexual intercourse

Many women we speak to have had severe prolpase and urinary incontinence prior to the procedure. They now are in pain,the prolapsed condition has returned and the incontinence is worse.  These women are in constant pain. What is worse, they are having trouble finding a doctor who can remedy the problem.

"There are clear risks associated with the transvaginal placement of mesh to treat POP," said Dr. William Maisel, deputy director and chief scientist of the FDA's Center for Devices and Radiological Health, in an agency release in July, updating 2008 warnings that addressed concerns about adverse events associated with the transvaginal placement of the mesh. "The FDA is asking surgeons to carefully consider all other treatment options and to make sure that their patients are fully informed of potential complications from surgical mesh. Mesh is a permanent implant – complete removal may not be possible and may not result in complete resolution of complications."

Lisa Spitzer MSW who runs the Transvaginal mesh helpline comments" As far as I am concerned it is the FDA's job to protect the consumer"The FDA      510(k) process failed to protect the thousands of women who had this vaginal mesh surgical procedure""It seems that the manufactureres and doctors are now fighting it out" " Our callers are women whose lives have been disrupted" "Theu no longer trust their doctors"" it seems like the doctors are runing scarred now too"

The FDA has set no time frame for deciding the fate of the vaginal mesh, or the 510(k) process.The Manufacturers   of the Mesh products keep saying there is nothing wrong with their products. "Key to the successful treatment of POP with surgical mesh is appropriate patient selection and surgeon experience." Now, doctors are the cause of problems experienced by hundreds of women, not a faulty device that was never properly tested." Others are saying that the meshes are failing due to poor tissue or the choice of who the procedure is done on" says Spitzer. " The bottom line is 1000's of women are effected while Doctors and manufacturers pplay the blame game."

Let me see if I get this straight-The woman who are candidates for the mesh procedure, are candidates because of weakened muscles which are resulting in prolapse and urinary incontinence. The mesh , it i claimed, Is  to rectify this problem in women who have weakened vaginal  muscle and tissue. But, the Doctors are putting this in women with poor tissue, so they are making the wrong choice in patients. Sorry but " I cannot get the logic here".

The helpline is available 24/7 to hel;p women, offer support and connect women to an attorney…Lawusuits are currently being filed against the "manufacturers" not physicians.  To contact the helpline cal 1 877 522-2123

Yaz,Yasmine,Ocella Helpline Launched Bad Drugs for Birth Control

Written by Auto Accident. Posted in Accidents Injuries Wrongful Death

Injury Lawyer Network Announces Yaz Yasmin Helpline Women's Health Lawyers Division

There are many Dangerous Drugs and medical Devices Hitting our Airwaves. Injury Lawyer Network announces yet another Helpline, Yaz Yasmine Helpline and support group. Many of these dangerous Drugs and Surgical Implants are effecting woman.

Over the years drug companies quickly develop drugs that profit over people.  Knowing full well that modern woman are very active and on the go, the drug industry has developed expensive types of birth control and many other drugs and medical devices that effect women According to Lisa Spitzer MSW who runs the Women's Health Lawyer Helplines" have marketed to these progressive woman many drugs and birth control methods and  surgical implants.professing to improve quality of life"   "Unfortunately for women, the drug companies did not adequately test these drugs or medical devices "or Maybe just hide bad test results from the public so they can make billions of dollars."  Yaz, is the latest in a series of drugs that are being investigated for harmful side effects like heart attacks, blood clots, strokes, gallbladder disease, and many other complications. Because of this Injury lawyer network has added a Yaz helpline and support group for women. According to Spitzer" so many of these drugs and surgical implants are directed toward women that we have  have launched and women's Health lawyer legal department

History of Yaz
In 2001 Yaz was created by Bertex Laboratories where it was called Yasmin.  In 2006, Bayer Healthcare took over the Bertex Company and reintroduced Yasmin as Yaz.  Over the last three years, Yaz has turned into not just the most popular birth control method in the U.S. but the most profitable as well. Bayer has done a major marketing campaign in order to accomplish this.  Bayer has its salesmen going into doctor’s offices with its product offering free dinners and trips and all that is asked in return is that the doctors’ prescribe Yaz.  
FDA Involvement
The Food and Drug Administration has been investigating Yaz over the past few years and were the first to recognize that there was a problem in the marketing of this drug.  First the FDA warned that Bertex was not giving the public adequate information about Yasmin’s side effects and that Bertex was making unproven claims that their product was superior to competitive products. Five years after this, when Bayer began to aggressively market Yaz as a miracle drug to cure all sorts of problems, the FDA warned them that their claims were misleading to the public. They went on to let Bayer know that it was unacceptable for them to sell Yaz for any purpose other than birth control.
Although, Bayer has been forced to change its marketing methods, many women have suffered from its harmful side effects or developed serious health conditions as a result of their false advertising campaign.
Yaz Side Effects
It is alleged that Yaz causes side effects as dangerous as heart attack, strokes, blood clots, pulmonary embolisms, and gallbladder disease. There has also been discussion that Yaz that can eventually lead to serious health issues over time. If you think you are experiencing any of these side effect, no matter the reason that your were prescribed Yaz, you must see a doctor and get treatment or see if you should be taken off of Yaz.
You would have thought that all of this negative publicity would have detered Bayer from making Yaz or from aggressively marketing the product, but the answer is no.   Yaz is still one of the most popular birth control methods in the U.S. Bayer is being irresponsible to patients by continuing to produce and sell Yaz.   But can we really be surprised, Bayer is just doing what it has for years;  putting profits over people.  Just how many strokes do young women have to endure before Bayer will pull the plug on this dangerous drug.

 

 

"My suggestion is that if you or a loved one has been injured by Yaz, Yasmin,Ocella or the Transvaginal mesh,prolapse mesh that you seek the advice of a competent lawyer to understand your rights.  Having a stroke just because you do not want to get pregnant is not right.  Contact our helpline for support, advise and to connect with a lawyer"
According the Spitzer " I am interested in the psychological and emotional effects of these drugs and medical devices on women. When a car has a recall or gets a bad oil change that is one thing.""Drug and medical device companies are playing with peoples lives"
Medical technology in today's society is often seen as a way to improve quality of life. The term medical technology refers to the diagnostic or therapeutic application of science to improve  the individual. Unfortunately, the negative impacts of this technology are often left unexposed to the public until too late."When a drug turns bad or a medical device literally falls apart in a woman's body" "We have technology gone astray or greed and selfishness pervading" Say Spitzer. " The women I talk to no longer trust their doctors", "This is a sad situation" "These woman are emotional wrecks" " the entire families are effected" For more information  see InjuryLawyernetwork.net or call the helpline  at 1 877 522 2123

 

# # #
 

Woman's Health lawyer dept of Injury lawyer Network has launched numerous helplines for woman. Lisa Spitzer who runs the helplines is a New York Licensed MSW, currently residing in Palm Beach County Florida. Injurylawyernetwork.net is the website. 1 877 522-2123 is the contact number.

Injury lawyer Prolapse Mesh Helpline is Hearing the Cries of Women Worldwide

Written by Auto Accident. Posted in Accidents Injuries Wrongful Death

The meetings continue today but, the FDA panel already appears to be heavily in support of an FDA plan to reclassify all vaginal mesh as Class III devices.If this is done, Medical device makers who fast-track approval of the devices will have to do detailed clinical trials before being allowed to put them on the market.  Existing products will be allowed to remain on the market.

The pelvic organ prolapse surgical mesh products, which are implanted through the vagina, are currently considered a Class II medical device.  This means that manufacturers can apply for approval through the FDA’s 510(k) approval process. That process  requires that a manufacturer show that the device is substantially equivalent to an existing device on the market, without requiring increased clinical testing.

The various vaginal mesh products have been in the news the past few  weeks due to the current FDA meetings with clinicians and manufacturers.
Because of the many Horror Stories ,Injury Lawyer Network now has an online support group for women to share their stories and get support from other women. According to Lisa Spitzer MSW, Injury lawyer Network" The vaginal surgical mesh complications have  taken their toll on women not just physically but, psychologically." Spitzer says"These side effects have added stress to marriages and changed the quality of life of women effected." "I have listened to so many horror stories"says Spitzer. "Women need a support group to share their feelings and experiences." "They should not be left to feel helpless and alone"." The approval the FDA gave these companies was inadequate", continues  Spitzer. "These women have suffered severely." One woman who called today said "This is effecting entire families. When mommy does not feel good the entire family suffers". Spitzer continues "women call in tears,  lives  completely turned around.They are in constant pain.""Many have lost faith in their doctors and do not know where to turn or  what doctor to trust". "Men are being effected as well when the mesh erodes thru the vaginal wall."" The stories are endless.""The pain, suffering and tears is a daily occurrence on the helpline."

An FDA advisory panel considering the use of trans vaginal mesh leans toward reclassifying the products as high-risk without issuing a recall. "It is Important that women involved be updated," says Spitzer MSW and spokes person for Injury Lawyer Network. Over 3000 Vaginal mesh patch, Vaginal Mesh lawsuits have been filed Nationwide. Over 300,000 women have been treated for uterine prolapse. According to Spitzer"this is a worldwide problem.""We have had calls from Canada and the UK."

Injury Lawyer Network is not just lawyers interested in cases. They offer support and help to women going thru this traumatic experience. The helpline is not only a means of connecting with an experienced physician, but also support and information. Women are encouraged to leave their stories on line for other women to read and know they are not alone. According to Spitzer,spokes person for Injury Lawyer Network "women should see a physician immediately to know where they stand and make available all avenues for financial compensation."  Spitzer continues," For the stories I hear ,there is no compensation large enough that will justify this kind of pain and suffering" Injury Lawyers Networks' Surgical mesh legal team is accepting claims against the various manufacturers for the women who are victims. Spitzer says," the FDA must hear these suffering voices and act"

FDA Issues Actos Bladder cancer Warning

Written by Auto Accident. Posted in Accidents Injuries Wrongful Death

June 15, 2011 — The FDA issues an Actos bladder cancer warning, saying that use of the Actos  drug for more than one year could be associated with an increased risk of tumors. The federal drug regulator agency ordered new information about the potential link between Actos and cancer of the bladder be added to the Warnings and Precautions section of the drug label. When compared with individuals who had never used the medication, the FDA indicated that Actos use for 12 months was associated a 40% increase in the risk of bladder cancer.

Injury Lawyer Network Attorneys are concerned about these Actos bladder cancer  warnings. Takeda Pharmaceuticals, who put actos on the market should have been aware of the potential side effects

Actos (pioglitazone) is a medication for treatment of Type 2 diabetes. Actos is showing an increased potential for bladder cancer in long term use.

Many European markets have already removed actos from the shelves.

 

Possible signs or symptoms of Actos bladder cancer may include:

Symptoms

Symptoms of bladder cancer can include:

    Abdominal pain

    Blood in the urine

    Bone pain or tenderness

    Fatigue

    Painful urination

    Urinary frequency

    Urinary urgency

    Urine leakage (incontinence)

    Weight loss

According to Lisa Spitzer MSW who runs the Injury Lawyer Network Actos Hotline

"A diagnosis of type 2 diabetes brings lifestyle changes"  "Patients hoped for an improvement to their quality of life with actos""Patients who call us have lost faith in their doctors""Type 2 diabetes has very server medical ramifications""These warnings produce fear""Tghe diabetes diagnosis effects the entire family and caregivers""The thought of a loved one developing bladder cancer from a promise of a better life brings despair" "Bladder cancer is aserious disease,costly to treat and the prognosis is poor"

We welcome caregivers and patients to call our hotline. Injury lawyer network Attorneys are accepting clients for Actos litigation

Call and speak to an actos lawyer today 1 877 522 2123

 

 

 

Injury Lawyer Network Launches Actos Helpline for Diabetics

Written by Auto Accident. Posted in Accidents Injuries Wrongful Death

Injury Lawyer Network has launched a Helpline for Diabetics effected by the Drug Actos.ACTOS is a prescription drug used with diet and exercise to improve blood sugar (glucose) control in adults with type 2 diabetes. ACTOS is not for patients with type 1 "juvenile" diabetes or diabetic ketoacidosis. According to Lisa Spitzer Msw"It is  impossible  for a  patient to  assess the safety of a drug before taking it.".  Helpless and vulnerable patients rely on others such as drug manufacturers,physicians and pharmacists to help  make the right decision regarding  the medications they take". While many drugs do what they are intended to do and help relieve symptoms improve  quality of life, some drugs are defective and dangerous".  Patients trust the physicians and when a "good" drug turns bad they do not know where to turn. The Actos helpline offers support, assistence and connection to an actos lawyer. " Patients need to know their rights and that if they have suffered injuries, or a loved one has died, because of a defective or dangerous drug they  may be entitled to damages""Some groups have a higher risk for developing type 2 diabetes than others. Type 2 diabetes is more common in African Americans, Latinos, Native Americans, and Asian Americans, Native Hawaiians and other Pacific Islanders, as well as the aged population." According to Spitzer "caregivers must step up to assist their patents who are affected by actos" "Being the primary caregiver for a person who has diabetes can take an emotional toll. A diabetics' caregiver may be the one taking ownership of his or her loved one's diabetes if the person with diabetes doesn't or can't." "There may be feelings of guilt,that is why they must step up on behalf of their patients and loved ones to protect them" Injury lawyers Helpline for Actos and Diabetics and their caregivers offers support as well as a complete legal team experienced in this litigation. The actos lawyers understand the emotional and medical issues surrounding diabetics and the bad drug actos (pioglitazone).

 

Type 2 diabetes, also known as adult-onset or noninsulin-dependent diabetes, is a chronic condition that affects the way your body metabolizes sugar (glucose), your body's main source of fuel.

 Insulin is a hormone that regulates the movement of sugar into your cells.With type 2 diabetes, your body either resists the positive effects of insulin or doesn't produce enough insulin to maintain a normal glucose level. Untreated, type 2 diabetes can be life-threatening.                                                                                                                                                                                     Complications of Diabetes                                                                                                                                                         Diabetes can lead to high blood sugar levels, a condition called hyperglycemia. Over a long period of time, hyperglycemia damages the retina of the eye, the kidneys, the nerves, and the blood vessels.

  •     Damage to the retina from diabetes (diabetic retinopathy) is a leading cause of blindness.
  •     Damage to the kidneys from diabetes (diabetic nephropathy) is a leading cause of kidney failure.
  •     Damage to the nerves from diabetes (diabetic neuropathy) is a leading cause of foot wounds and ulcers, which  frequently lead to foot and leg amputations.
  •     Damage to the nerves in the autonomic nervous system can lead to paralysis of the stomach (gastroparesis), chronic diarrhea, and an inability to control heart rate and blood pressure during postural changes.
  •     Diabetes accelerates atherosclerosis, (the formation of fatty plaques inside the arteries), which can lead to blockages or a clot (thrombus). Such changes can then lead to heart attack, stroke, and decreased circulation in the arms and legs (peripheral vascular disease).

Actos & AvandiaIf you or a loved one is experiencing the side efffects of the diabetes drug actos call and speak to an actos lawyer today 1 877 522 2123. Current warnings show actos may cause bladder cancer with long term use.

 

 

 

As of June 10, 2011 doctors in France and Germany have been instructed not to proscribe the drug Actos to their patients and the drug Actos has actually been removed from pharmacy shelves. The reason for these actions is because recent studies have shown that an patients who use the drug Actos to treat their Type 2 Diabetes by using Actos are more likely to contract bladder cancer.
What makes this fact more difficult to accept is that it appears that the incidence of Bladder Cancer in people using the drug Actos, was known to the drug manufacturer Takeda, Inc. in the clinical trials  However, even though, Takeda, Inc. apparently knew that the drug Actos would cause bladder cancer, it still marketed and sold  2.3 million prescriptions for the drug Actos in the United States in one year alone. 2010.   The active ingredient in Actos, Pioglitazone, is also used in ActoPlus met, ActoPlus met XR and Duetac to treat Type 2 Diabetes.
On June 15, 2011, the FDA issued an urgent health warning to users and prescribers of the drug Actos acknowledging the recent statistical data that shows up to a 40% increase in risk for bladder cancer in users of Actos. The studies further show that the risk of bladder cancer increases with higher dosages and longer courses of treatment with Actos.
After the health warning was issued the FDA will now require that these recent findings and risks be included in warnings attached to the drug packaging and future marketing materials. The FDA is also going to continue monitor the data being released by various ongoing studies into the long term health effects of Actos (Pioglitazone).  In the meantime, Actos remains available to consumers in the United States despite these newfound risks.

 

Injury Lawyer Networks Actos lawyers are able to immediately reivew your potential claim to let you know if you are possibly due recovery for injuries to your bladder or heart                  Call 1 877 522-2123

 

Compensation for Actos Injuries

If you or a loved one has been injured by taking Actos, you may be entitled to compensation including:

·      Medical expenses

·      Future medical expenses

·      Lost income

·      Future lost income

·      Lost earning capacity

·      Pain and suffering

·      Loss of enjoyment of life

·      Loss of consortium

·      Emotional anguish

·      Wrongful death

Possible signs or symptoms of Actos bladder cancer may include:
Blood in the Urine
Pain During Urination
Frequent Urination
Feeling of Need to Urinate Without Results

A similar drug, Avandia, has already been removed from the market after being linked to an increased risk of heart attacks. In fact, Actos and Avandia are the only two drugs in their class, called thiazolidinediones, and work in very similar ways. in a study released August 24, 2010 Actos was found to have the same dangerous side effects as Avandia.  So it appears that Actos may cause heart disease and heart attacks.

Compensation for Actos Injuries

If you or a loved one has been injured by taking Actos, you may be entitled to compensation including:

·      Medical expenses

·      Future medical expenses

·      Lost income

·      Future lost income

·      Lost earning capacity

·      Pain and suffering

·      Loss of enjoyment of life

·      Loss of consortium

·      Emotional anguish

·      Wrongful death

 

Injury Lawyer Network has Actos Lawyers ready to help you in:Alabama, Al, Alaska, Arizona, Az Scottsdale, Arkansas, California, Ca, Colorado, Co, Connecticut, Conn, Delaware, De, D.C., Florida, Fl, Georgia, Ga, Hawaii, Idaho, Illinois, Ill, Indiana, Iowa, Kansas, Kentucky, Louisiana, La, Maine, Maryland, Massachusetts, Mass, Michigan, Mi, Minnesota, Minn, Mississippi, Ms, Missouri, Mo, Montana, Nebraska, Nevada, Nv, New Hampshire, New Jersey, N.J., New Mexico. N.M, New York, N.Y, Brooklyn, Queens, Staten Island, Long Island Westchester, North Carolina, North Dakota N.C, Ohio, Oh, Oklahoma, Ok, Oregon, Pennsylvania, Pa, Rhode Island, RI, South Carolina, S.C, South Dakota, S.D, Tennessee, Tenn, Texas, TX, Utah, Ut, Vermont, Virginia, Washington, Wa, West Virginia, Wisconsin, Wyoming.

Current Class Actions

Written by Auto Accident. Posted in Accidents Injuries Wrongful Death

current class action Updates Transvaginal mesh Injury Lawyer Networks transvaginal mesh lawyers continue to hear from women daily.

Gynecare Prolift Transvaginal Mesh Named in Lawsuit
Oct 11, 2011
 

Johnson & Johnson continues to be named in lawsuits alleging its Gynecare Prolift transvaginal mesh left women with permanent and painful injuries.  The most recent lawsuit was filed by Linda Gross, 46, of Watertown, South Dakota, who received Gynecare Prolift transvaginal mesh in 2006 to repair pelvic organ prolapse (POP).

Since her initial surgery, gross say she has suffered urinary complications and constant pain due to her body's rejection of the Gynecare Prolift device. According to her complaint, Gross has undergone 12 additional surgeries, but has had no relief.   Today, Gross says she cannot sit for longer than 20 minutes, cannot have sex with her husband, and she can’t be active for more than a few minutes at a time.

In July, the U.S. Food & Drug Administration (FDA) said in a safety communication that it had received 1,503 reports of serious complications associated with transvaginal mesh used in POP repair, including mesh erosion through the vagina, pain, infection, bleeding, and pain during sexual intercourse, organ perforation, and urinary problems. The agency also said that its review had not seen any evidence that POP repair with transvaginal mesh offers any additional benefits compared to other treatment methods.

Last month, FDA staff proposed that such devices be moved to the agency's high -risk medical device category, which does not allow 510(k) clearances.  Under the FDA proposal, transvaginal mesh devices already on the market would be allowed to remain, but manufacturers would have to conduct studies to asses their safety and effectiveness.  An FDA panel of outside experts has backed both proposals.

Attorneys report that they are receiving an "amazing number of calls" from women who allegedly suffered transvaginal mesh complications following surgery to repair POP.  As we've reported previously, about 300,000 women in the U.S. had POP surgeries last year, including more than 70,000 who received transvaginal mesh.

Injury lawyer Network continues to hear from women on a daily basis regarding their Transvaginal mesh Compications.

                                                                                                                                                              

Vaginal Mesh Faces FDA Review Vaginal Mesh Helpline

Written by Auto Accident. Posted in Accidents Injuries Wrongful Death

J&J Vaginal Mesh Faces FDA Panel's Review as Lawsuits Rise

Wednesday, September 7, 2011

Sept. 8 (Bloomberg) — Johnson & Johnson and C.R. Bard Inc. may have to submit more safety data on a type of surgical mesh that has led to about 500 lawsuits against the manufacturers.

A panel of U.S. Food and Drug Administration advisers is meeting today and tomorrow on whether the mesh, which supports weakened muscles that can't hold a woman's pelvic organs in place, is safe and effective. If not, the device makers may be required to provide more data to keep their products, approved by regulators under an abbreviated process, on the market.

Marci Sutin Levin, who has sued J&J over her injuries, says the FDA failed her when they didn't require extensive testing before allowing J&J to sell the mesh implanted in her in 2007. The device was cleared under the agency's 510(k) process, which allows approval without substantive studies if a product is "substantially equivalent" to others already on the market.

While the mesh has been used for more than three decades, mainly for hernias, its use "has evolved over the past few years" as manufacturers expanded into other conditions, Herbert Lerner, an acting director in the FDA's device-approval center, told the panel today. "As industry modified surgical mesh for these indications, none of the mesh has been evaluated for clinical data."

Levin, a 65-year-old New York marketing executive, is one of about 75,000 women-a-year who have the devices inserted vaginally to treat pelvic organs that bulge, or prolapse. She said in an interview that she endures pain so intense she can't work, sleep through the night or have sex with her husband. It hurts worse than natural childbirth, she said.

'Pain of Childbirth'

"The pain of childbirth was finite, and you're delivering a child," Levin said in an interview. "This was very, very different. It's relentless, and it's untenable. And it doesn't lead to anything."

Levin filed one of about 270 lawsuits pending against J&J, based in New Brunswick, New Jersey. Bard, of Murray Hill, New Jersey, and other mesh makers also face litigation around the U.S. About 75,000 women a year have the devices inserted vaginally to treat pelvic organs that bulge, or prolapse.

The FDA warned July 13 of a rise in injuries related to the mesh, and it said last month the devices should be reclassified from moderate risk to high risk, a change that would typically require new clinical data.

The advisory panel will also discuss mesh used for stress urinary incontinence in addition to whether transvaginal mesh for pelvic organ prolapse, or POP, is safe and effective.

Institute of Medicine Report

The FDA is weighing a U.S. Institute of Medicine report in July urging it to scrap the 510(k) process for moderate-risk devices. The current system allows devices like the mesh implant to enter the market if manufacturers show they are "substantially equivalent" to others already for sale. The IOM said a new process should be devised that provides reasonable assurance of the safety and effectiveness of moderate-risk devices.

"The clinical effectiveness of surgical mesh for transvaginal repair of POP has not been demonstrated," said William Maisel, deputy director of the FDA Center for Devices and Radiological Health, in a telephone interview. "We believe proper studies would need to be done."

An industry working group disputes the FDA's suggestion that the devices should be reclassified. Its members include mesh makers J&J; Bard; Boston Scientific Corp. of Natick, Massachusetts; and American Medical Systems, acquired in June by Endo Pharmaceuticals Holdings Inc. of Chadds Ford, Pennsylvania. The Advanced Medical Technology Association, the manufacturers' lobbying arm in Washington, is also a member.

'Safe and Effective'

The group believes that the use of mesh in transvaginal procedures for prolapsed organs is "safe and effective, that serious adverse events remain rare and it is a valuable treatment option for women," it wrote on Aug. 30 to the advisers. "Key to the successful treatment of POP with surgical mesh is appropriate patient selection and surgeon experience."

A spokesman for J&J, Matthew Johnson, declined comment on the litigation. Bard spokesman Scott Lowry declined to comment on about 190 lawsuits it faces over its Avaulta pelvic mesh.

Adam Slater, the New Jersey attorney who represents Levin and about 100 other women who have sued J&J or Bard in New Jersey state court, said the agency is "at an important crossroads" over how to protect patients.

'Utterly Failed'

"The 510(k) process utterly failed to protect the thousands of women who were implanted," Slater wrote to the advisers. "Now the FDA now has the opportunity to at least protect women on a going-forward basis."

While the advisory panel won't take any formal votes this week, the FDA will poll the panel of researchers and physicians on whether to reclassify the devices and gather thoughts on how to conduct clinical studies, said Karen Riley, an agency spokeswoman, in a telephone interview yesterday. It's not clear yet when the FDA will make a final decision on the devices, she said.

The mesh devices should be recalled, said Slater, of the law firm Mazie Slater Katz & Freeman in Roseland, New Jersey. Public Citizen, a consumer advocacy group in Washington, made a similar call in a statement last month.

Studies to determine if devices reviewed under the 510(k) process are safe and effective are rare, the Institute of Medicine said last month. Levin said that process failed to detect risks posed by her mesh, made by J&J's Ethicon unit.

'Irrevocable'

"It wasn't carefully tried and tested before it was implanted into me," she said. "I was told that it was a real improvement, that this would be great and I would be back at work in two weeks. It was irrevocable, what they did to me."

The mesh under review supports pelvic floor tissues that weaken or stretch as women undergo childbirth and age, causing organs including the bladder, rectum or uterus to bulge into the vagina. More than 2 million women are diagnosed with the condition each year, according to the industry working group.

About 300,000 women in the U.S. had pelvic organ prolapse surgeries last year. Between 2008 and 2010, the FDA received 1,503 reports of injury, malfunction or death associated with the surgery, a five-fold increase over the previous three-year period. Injuries include infection, organ perforation, urinary problems and mesh erosion.

Abdominal Hernias

Surgeons began using mesh in the 1950s to repair abdominal hernias. In 1996, the FDA cleared the first mesh product for stress urinary incontinence, and in 2002, the agency cleared the first mesh device for prolapse.

An FDA review of 110 studies that examined mesh in 11,785 women showed 10 percent had erosion within 12 months. Seven deaths were also reported, including four due to medical complications not directly related to the mesh placement procedure, according to the FDA.

Dr. Clifford Wheeless, an emeritus associate gynecology professor at Johns Hopkins University School of Medicine, said he has long told colleagues that inserting mesh transvaginally is inherently unsafe.

"You can't take a mesh from Company A, put it through the contaminated vagina, implant it under the bladder, and not get a rejection or an abscess," Wheeless said. "There's so much of the FDA's time wasted on thinking that Mesh A is going to be better than Mesh B, and Mesh C will be better than Mesh B. They don't understand the basic science of foreign bodies."

A recall would be too extreme, said another pelvic surgeon, Andrew Sokol, an associate professor at Georgetown University School of Medicine in Washington. He helped conduct a clinical trial of transvaginal POP mesh that found a 15.6 percent erosion rate after three months. Still, he said that the devices have their benefits for some women.

"We do these surgeries all the time without risk," said Sokol. "Thousands and thousands of these surgeries are done without complications. The data is still emerging. It's easy to react but what needs to be done are good studies."

If you have been injured by the vaginal mesh :Gynecare Prolift, Bard Avaulta, Boston Scientific Pinnacle and Uphold, and AMS (American Medical Systems) Apogee, Perigee, and Elevate

Injury Lawyer Network     Attorneys Vaginal mesh Litigation Help call 1 877 522-2123

VAGINAL MESH UPDATE

FDA's device-approval center, told the panel today. "As industry modified surgical mesh for these indications, none of the mesh has been evaluated for clinical data."

 

Vaginal Mesh An Outrage For Women

Written by Auto Accident. Posted in Accidents Injuries Wrongful Death

 

 
Posted On: March 11, 2011

Bard Avaulta Vaginal Mesh Complications Cause Outrage in Patients

Women who have been implanted with a defective Bard Avaulta vaginal mesh are outraged, and with good reason. The device was designed to prevent pelvic organ prolapse (POP), which can occur in women after childbirth or surgery. Unfortunately, the women affected by this defective product simply traded one dangerous condition for another.

POP occurs when the normal support of the vaginal wall is lost, and can also lead to the bladder and bowels sagging or dropping. Many victims of this condition experience a considerable amount of physical pain and discomfort. Although POP is most definitely an unfavorable condition, it is becoming painfully obvious that the possible negative side-effects of implanting the Bard Avaulta device are far worse.

Product Defect Side Effects

Problems with the Bard Avaulta product haven't gone unnoticed by authorities. In October 2008, the FDA issued a warning about products similar to the device. The warning indicated that these defective products may be contributing to hundreds of reports of pain, urinary problems, and blood vessel perforations.

The following are common problems reported by women after a Bard Avaulta Procedure:

 

 

 

 

 

 

 

 

  1. Injury to nearby organs
  2. Erosion of the mesh into the vagina
  3. Infection
  4. Recurrences of prolapse
  5. Urinary problems
  6. Pain during sexual intercourse
  7. Bowel, bladder and blood-vessel perforations

Many victims of this product defect are finding it hard to come forward. Many feel embarrassed and depressed due to their seemingly endless number unfortunate events unfolding one after the other. If you feel this may be you, please visit your doctor and fully disclose the extent of your pain and discomfort. Things may seem like they can't get worse, but they aren't going to get better until you seek proper treatment physically and psychologically. Posted on March 11 2011 by Auto Defect Attorney

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Transvaginal Mesh Lawsuit Attorneys Vaginal Mesh Helpline 1 877 522-2123

Transvaginal MeshAlso referred to as a pelvic sling, bladder mesh, or transvaginal mesh vaginal mesh support systems are used to fix pelvic organ prolapse and stress urinary incontinence, and have been known to cause serious internal injuries.  These transvaginal mesh patch implants, manufactured by Johnson & Johnson, C.R. Bard, Boston Scientific, American Medical Systems, and others, may cause pain, infection, erosion, organ damage, and corrective surgeries, among other vaginal mesh injuries.

If you have experienced vaginal mesh complications following pelvic organ prolapse surgery or stress urinary incontinence call the vaginal mesh Helpline at 1 877-522-2123

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Class Action Lawsuits Hitting Our Airwaves

Written by Auto Accident. Posted in Accidents Injuries Wrongful Death

            Class action lawsuits for a new drug or orthopedic device gone bad is the focus of lawyer advertising these days. One of the major new class actions is the vaginal mesh. This vaginal mesh patch is made of synthetic fibers and has caused vaginal complications. The mesh goes under many names and each lawyer seems to use different terminology.The Bard Avaulta is one of these Transvaginal Mesh products. It is also called the vaginal patch,vaginal mesh,prolift mesh,vaginal sling,vaginal mesh prolapse, Trans Vaginal mesh, vaginal vault prolapse mesh, and vaginal mesh prolapse support. The mesh has been seperating and women are experiencing pain "equal to barbed wire". Johnson and Johnson and other manufacturers are currently being pursued on behalf of women who had vaginal mesh surgery to help with incontinence and a prolapsed uterus. TVT surgery is also relevant to the vaginal prolapse surgey class action litigations. These transvaginal mesh malfunctions cause vaginal erosion, infection,increased incontinence, and other serious side effects. The vaginal mesh treats vaginal uterine prolapse,and urinary incontinence. These may naturally occur for women as a part of the aging process,during child birth or after an accident or severe injury.

         The hip replacement recalls are other big class action lawsuits. Included in this are the Zimmer Duram Cup,Johnson and Jonson DepuyASR and Pinnacle and Stryker. These are considered to be defective hip replacements or defective hip prothesis. In Addition there are numerous knee recalls. The Zimmer nexgen knee replacement recall appears to be the most advertised. There is also a biomet hip replacement recall as well as the birmingham hip resurfacing recall. With so many of these,one would have to wonder how many people are being effected.

           Other current class actions getting significant T.V attention include: Ocella,due to significant side effects;yaz due to blood clotts and zoloft due to birth defects. Litigation law firms are actively pursueing victims. It is suggested that if you or a loved one is a victim of any bad orthopedic device or bad drug you must see your doctors immediately and contact a class action lawyer to protect your rights. The author of this artcle has great concerns from a social work perspective for our older active community. The seniors of today are not like our parents. they are living longer with a more active lifestyle. She has read stories of grandparents unable to see their grandchildren due to the severe complications from either the vaginal mesh or the different hip replacements. Our older population must stay active to stay independent and enjoy the years they have worked so hard for.

            Class action lawsuits for a new drug or orthopedic device gone bad is the focus of lawyer advertising these days. One of the major new class actions is the vaginal mesh. This vaginal mesh patch is made of synthetic fibers and has caused vaginal complications. The mesh goes under many names and each lawyer seems to use different terminology.The Bard Avaulta is one of these Transvaginal Mesh products. It is also called the vaginal patch,vaginal mesh,prolift mesh,vaginal sling,vaginal mesh prolapse, Trans Vaginal mesh, vaginal vault prolapse mesh, and vaginal mesh prolapse support. The mesh has been seperating and women are experiencing pain "equal to barbed wire". Johnson and Johnson and other manufacturers are currently being pursued on behalf of women who had vaginal mesh surgery to help with incontinence and a prolapsed uterus. TVT surgery is also relevant to the vaginal prolapse surgey class action litigations. These transvaginal mesh malfunctions cause vaginal erosion, infection,increased incontinence, and other serious side effects. The vaginal mesh treats vaginal uterine prolapse,and urinary incontinence. These may naturally occur for women as a part of the aging process,during child birth or after an accident or severe injury.

         The hip replacement recalls are other big class action lawsuits. Included in this are the Zimmer Duram Cup,Johnson and Jonson DepuyASR and Pinnacle and Stryker. These are considered to be defective hip replacements or defective hip prothesis. In Addition there are numerous knee recalls. The Zimmer nexgen knee replacement recall appears to be the most advertised. There is also a biomet hip replacement recall as well as the birmingham hip resurfacing recall. With so many of these,one would have to wonder how many people are being effected.

           Other current class actions getting significant T.V attention include: Ocella,due to significant side effects;yaz due to blood clotts and zoloft due to birth defects. Litigation law firms are actively pursueing victims. It is suggested that if you or a loved one is a victim of any bad orthopedic device or bad drug you must see your doctors immediately and contact a class action lawyer to protect your rights. The author of this artcle has great concerns from a social work perspective for our older active community. The seniors of today are not like our parents. they are living longer with a more active lifestyle. She has read stories of grandparents unable to see their grandchildren due to the severe complications from either the vaginal mesh or the different hip replacements. Our older population must stay active to stay independent and enjoy the years they have worked so hard for.

Lawyers Network can help you locate a vaginal mesh,patch mesh,vaginal sling,Avaulta Mesh lawyer in Alabama, Al, Alaska, Arizona, Az Scottsdale, Arkansas, California, Ca, Colorado, Co, Connecticut, Conn, Delaware, De, D.C., Florida, Fl, Georgia, Ga, Hawaii, Idaho, Illinois, Ill, Indiana, Iowa, Kansas, Kentucky, Louisiana, La, Maine, Maryland, Massachusetts, Mass, Michigan, Mi, Minnesota, Minn, Mississippi, Ms, Missouri, Mo, Montana, Nebraska, Nevada, Nv, New Hampshire, New Jersey, N.J., New Mexico. N.M, New York, N.Y, Brooklyn, Queens, Staten Island, Long Island Westchester, North Carolina, North Dakota N.C, Ohio, Oh, Oklahoma, Ok, Oregon, Pennsylvania, Pa, Rhode Island, RI, South Carolina, S.C, South Dakota, S.D, Tennessee, Tenn, Texas, TX, Utah, Ut, Vermont, Virginia, Washington, Wa, West Virginia, Wisconsin, WyomingNorth Carolina, North Dakota N.C, Ohio, Oh, Oklahoma, Ok, Oregon, Pennsylvania, Pa, Rhode Island, RI, South Carolina, S.C, South Dakota, S.D, Tennessee, Tenn, Texas, TX, Utah, Ut, Vermont, Virginia, Washington, Wa, West Virginia, Wisconsin, Wyoming

Vaginal Mesh A womens Story

Written by Auto Accident. Posted in Accidents Injuries Wrongful Death

Image: 110722_FDA devices

Ben Sklar for msnbc.com

Janet Holt, a rancher from Floresville, Texas, had a mesh implant placed during a bladder-lift surgery that resulted in seven surgeries to repair the damage. The FDA approved the mesh lining, commonly used for hernias, but has now issued a warning of its complications.
By

 

 

 

msnbc.com contributor
updated 7/26/2011 9:48:19 AM ET

Janet Holt figured she simply had an infection “down there.”

But instead of a prescription, her doctor told her she’d need a procedure. Her bladder had slipped out of place, creating an uncomfortable condition known as pelvic organ prolapse, which affects many women as they age.

Her doctor said he could fix it, building a kind of nest or cradle to prop up her insides. Holt doesn’t remember him ever mentioning that he was going to use something called surgical mesh to do the job. But he was the doctor, so Holt, a 50-year-old from San Antonio, Texas, agreed to the operation.

Four years later, however, the medical device that was supposed to fix Holt’s problem has caused a host of new ones, sparking constant pain and requiring seven more operations as other surgeons tried to remove the mesh, which had eroded into her vagina, bit by bit.

Holt has become a poster child for growing concerns about the government process that allows devices such as surgical mesh — made of the same material as Rubbermaid storage containers — to be used with no testing on patients before they’re allowed on the market.

“I don’t think I’m going to get any better,” says Holt, now 54, who has had to cut back on work at her family’s five restaurants and can no longer ride horses or play baseball with her young grandson.

Unlike prescription drugs, which must be proven safe and effective before they’re marketed, most medical devices have no such requirement. Only about 10 percent of devices, those deemed the riskiest, such as breast implants and implantable pacemakers, fall into that category. Surgical mesh, used to support organs that have slipped over time, does not.

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