Posts Tagged ‘C.R. Bard Inc.’

Another Vaginal mesh Story, Vaginal mesh Helpline, Can a vaginal mesh lawsuit Help ?

Written by Vaginal Mesh Helpline on May 21, 2012. Posted in Vaginal Mesh Stories, Vaginal Mesh lawyers

At the vaginal mesh helpline we are collecting stories from all over the web. "Women of the Vaginal mesh". You are not alone. Husbands of the vaginal mesh you are with us as well. Get a vaginal mesh lawyer, discuss and vaginal mesh doctor and get support at the vaginal mesh helpline.

It is almost three in the morning. I woke up suddenly, thinking I heard something. I hobbled through to the kitchen, every step reminding me of the mesh in my body, but the house was quiet. I put a cup of milk to heat in the microwave. While it warmed I began thinking about the woman who sent me an email before I went to bed. Another lost soul living in pain, unable to work and fighting our system. Trying to get disability and medical care is not made easy for women with mesh in their bodies. They fight pain daily and have to fight harder to get medical care, often without good result.
I checked my email to see if she had answered my question of which State she was in. Nothing. There was a story from a thirty-two year old woman who also has mesh in her body after a hysterectomy and can no longer care for herself or two children. Another life on hold and broken. Another family in serious trouble. I then checked to see how a friend had done today with his fundraiser. A fundraiser designed to help him and his wife try to save their lives and those of others. Mesh is responsible. Their house always close to foreclosure. He is always struggling to make enough money to take his wife on a long road trip to the doctor. Another two lives on the edge. Another family broken on the brink of collapse. I read his sad, broken words that the fundraiser was a wash. Maybe it was because it was the Easter weekend. Maybe it is the economy. Who knows. He felt beaten down. He said they were worse off than before. His words linger in my mind. Mesh is responsible.

Today is Easter Sunday. A holiday of joyful religious spirit for many. A holiday for children to hunt and find eggs. A Spring holiday with the promise of summer and carefree fun. Not for everyone. For those who have mesh in their body and the families who support them, there isn’t a lot to celebrate. Each day is a struggle. Financially, emotionally and physically. It takes a toll on all who are exposed to the perils of mesh.

I hope this friend will bounce back tomorrow and not feel a failure. I know he feels beaten and a failure as a man. A man who wants to help his wife get well. His spirit broken.

For all those who enjoy this spiritual holiday, there are many who can’t enjoy anything. The endless pain racking their body and destroying the life they once knew. Their family watching on the side lines unable to take away the pain. Mesh is responsible.

When will the world take notice?

Women of the Vaginal Mesh, You are not alone, Vaginal mesh Helpline

Written by Vaginal Mesh Helpline on May 21, 2012. Posted in Vaginal Mesh Stories, Vaginal Mesh lawyers

At the vaginal mesh helpline we speak to women everday from across the country and so many of them feel very alone with severe vaginal mesh complications. We found this on the web and are putting it on the site to share "women of the vaginal mesh" you are not alone.

Since CTV News first reported on a class action lawsuit filed on behalf of women who say they have had life-altering complications from something called transvaginal surgical mesh sling, more women have come forward with similar complaints.

Jane Dowall is one of those who got the mesh. She says she had no idea she would end up with so much constant pain.

"The pain is like a migraine headache… from the knees to navel," she says. "Sometimes it is burning, sometimes it is a sharp pain."

She rarely goes out, she says, and lives on painkillers — the result, she says, of a procedure that was meant to fix her stress urinary incontinence.

Dowall was one of dozens of women who contacted CTV News and class action lawyers after seeing our story about complications with transvaginal surgical mesh. The mesh is used in slings designed to treat incontinence and to support organs in the pelvis that have fallen from normal position.

For many women, the mesh does as it was designed to do. But many others say they have experienced complications after the mesh moved or began to fall apart.

Sheri Hanson says since she had mesh implanted in early 2010, she can't work and is on a disability pension because of pain. That money has to support her and her husband who has quadriplegia. Even while taking painkillers, she says her pain is constant and still ranks as a 5 on a scale of 1 to 10.

"I can't sit, it's difficult to drive. I can't sit more than five minutes before I am in bad pain," she says adding she feels guilty that she can't take care of her children properly.

"My greatest fear is that it gets worse than it is now. The mesh could migrate further," she says.

Diane Fichter says after she had the mesh implanted in October 2010, doctors discovered her mesh had come loose and was piercing her vaginal wall.

"It's very scary to know what is happening to my body and what the mesh is doing to my body," she says.

Perhaps the most disturbing case we heard about was that Nonie Wideman, who has discovered bits of purple mesh fibres that have broken off and have come out of both her vagina and her bladder in her urine.

"It's eroded into my urinary system and I am in trouble," she says, adding that the pain has left her suicidal.

She has now found a pain reliever that's working for her, but she's still searching for a surgeon qualified to remove the mesh from her body.

The husbands of many of the women who have had the mesh say they have also been affected. Many have described feeling a foreign substance in their partner during intercourse. Others have even had their penises scratched or cut during intercourse from mesh fibres that have punctured the vaginal wall.

And still others have found that their wives are in so much pain, physical intimacy is no longer a possibility.

Many doctors say transvaginal mesh has been a huge benefit for many women. Dr. Jens-Erik Walter of the Canadian Society of Pelvic Medicine, and the Urogynecology division at McGill University, says complication rates are low, between one and five per cent.

While some U.S reports suggest the complication rate could be closer to 10 per cent, Walter insists the products are safe.

"It is unfortunate that some women experience such complications but the risk of this is very low and the clinical efficacy of these procedures has been documented in clinical trials," he says.

The key, Walter says, is that the mesh has to be used in the right kind of organ prolapse patient, Walter says.

"There are certain populations where transvaginal mesh products should be avoided, for example: younger patients who have what we refer to as vaginal atrophy, which is a lack of estrogen in the vagina; and those patients who may be immune-compromised or who have poorly controlled diabetes, whose tissues may not accommodate the mesh as readily as others," he says

Mesh slings used for incontinence are more acceptable in the younger population if they have completed childbearing and are otherwise healthy, Walter added.

The devices also have to be properly inserted by well-trained surgeons.

"I don't think all of the surgeons carrying out these procedures have sufficient training to manage their complications and potentially thoroughly counsel these patients regarding these risks," he says.

The problem, though, say many affected women, is that the mesh is designed to become part of the body, so if the mesh starts to break down, it becomes very hard to remove. Many of these women say that while they were told there were some risks to the surgery, they were never told how devastating and life-changing the complications could be.

Had they known, most say they would have picked other ways of treating their health problems.

we hear vaginal mesh horror stories everyday. We speak to women who cannot find a doctor to help them. They are afraid to speak to a vaginal mesh lawyer. But, this is the only thing these manufacturers understand . You must get justice. "Women of the Mesh" mush get justice.

The Horrors of Drugs and medical Devices Harming Women, Vaginal mesh Helpline Reports

Written by Vaginal Mesh Helpline on May 18, 2012. Posted in Vaginal Mesh News

Dangerous Drugs and medical devices Effecting Women. Discussion presented by Vaginal mesh Helpline female medical Social Worker. The horrors of the vaginal mesh are beyond belief with so many stories of pain and suffering. But, a closer look takes us to a list of many drugs and medical devices harming women of all ages. Pharma seems to see women with dollar signs plastered to their heads. What we see and hear are women with lives destroyed and needing help and protection. Here goes the list of drugs and devices harming women. When you look at a senior population and woman baby boomers , college students, wives, daughters and mothers effected it become a huge market of women effected by what i call medical injustice.

The List

Amongest the medical devices and drugs harming women include :Bladder Sling, Mirena IUD, Vaginal mesh, Yaz, Yasmin, Fosamax, Topomax, DePuy hip replacement recall, Actos, Breast Implants, Tylenol, avaira toric contact lenses and others are harming women.
It is amazing to me how many dangerous drugs and medical devices are having an effect on women. TheVaginal mesh Helpline hears from women thru-out the country regarding their horrific experiences with these mesh devices. Yet, there are so many other drugs and medical devices that are hurting women. The Mirena birth control device, Yaz, Yasmin, Ocella, The DePuy Hip Replacement, metal on metal hip replacements, Zimmer Duram Cup, Breast Implants, Cytotec, Topamax Mirena birth control device, Yaz, Yasmin, Ocella, The DePuy Hip Replacement, metal on metal hip replacements, Zimmer Duram Cup, Breast Implants, Cytotec, Topamax and others,
Mirena Birth Control device

Mirena Silicone IUD
The Mirena Birth control device has caused amongst other side effects: Miscarriage, Risk Of Infertility, Intrauterine Pregnancy, Streptococcal Sepsis, Pelvic Inflammatory Disease Cervix, Severe Pain, Contraceptive Perforation and other side effects.
Some women have experienced serious adverse side-effects and potentially life-threatening complications following the implantation of the Mirena device, including perforation of or imbedment in the uterus.
Bayer actually marketed Mirena as a way women could simplify their lifestyle. One of the ways it did so was through "Mirena Parties." Working with the social networking site Mom Central, Bayer created a Mirena direct marketing program that consisted of a series of house parties hosted by members of the Mom Central community. Bayer was eventually warned against this. The stories have heard and read regarding this device are horrific. The IUD is moving from it's original position and severing the uterus and nearby organs.

Cytotec (Misoprostol)
It is estimated that in about 200,000 births in one year, Cytotec was used to stimulate delivery. This is where most of the problems with this drug, including birth defects have incurred. The purpose of the drug was for the prevention of ulcers, but it has also been used in abortions. Brain damage to infants is of particular concern.\

Yaz, yasmin Birth Control Pills
Studies recently published in the British Medical Journal, which concluded that women ages 15-44 taking birth control pills containing the synthetic progestin, drospirenone, are more likely to develop blood clots deep in the veins of the leg (venous thromboembolism), than women using birth control pills containing the common progestin levonorgestrel. Blood clots can move and if they end up in the brain or lungs can be deadly.

Yasmin and Yaz have reported incidents of :

Heart Attacks,
Strokes,
Cardiac Arrhythmias,
Blood Clots,
Deep Vein Thrombosis, (DVT),
Pulmonary Embolism, (PE,
Death,

Topamax
Topiramate, the generic form of Johnson & Johnson's anti-seizure drug, Topamax, is under fire from the Food & Drug Administration for its birth defect risks, Reuters reports. The medication is prescribed to patients suffering from epilepsy, and more popularly, to consumers with chronic migraine headaches. Topiramate has recently been combined with other drugs to battle obesity and bipolar disorder. More than 4.7 million prescriptions for Topamax were filled in the United States from 2007 to 2010, bringing in approximately $600 million worldwide last year.

FOSAMAX EFFECTS WOMEN
         The .Long-Term use of Fosamax has been shown to more then double the Risk of Femur Fractures Among Older Women.
An article in an issue of the Journal of the American Medical Association reports that long-term use of Fosamax and other bisphosphonate drugs by older women more than doubles their chance of suffering femur fractures. This side effect is particularly disturbing in light of the fact that Fosamax and similar drugs are prescribed to strengthen the bones of women with osteoporosis.
       .

TRANSVAGINAL MESH AND RELATED MESH PRODUCTS ARE THE BIGGEST HOORO EFFECTING WOMEN TODAY Over 300,000 women are effected and we speak to so many who tell us their stories of pain and suffering,
Manufacturers of Mesh Products Include:

Johnson & Johnson,
Ethicon TVT,
Gynecare TVT,
Gynemesh PS,
Prolene Polypropylene Mesh Patch,
Secur,
Bard,
Avaulta Plus BioSynthetic Support System,
Avaulta Solo Synthetic Support System,
Faslata Allograft,
Pelvicol Tissue,
PelviSoft Biomesh,
Pelvitex Polypropylene Mesh,
American Medical Systems or AMS,
SPARC,
Boston Scientific,
Advantage Sling System,
Obtryx Curved Single,
Obtryx Mesh Sling,
Prefyx Mid U Mesh Sling System,
Prefyx PPS System,

The trans vaginal mesh Continues to effect women and alter the lives of Women
Recent warnings have linked various birth control drugs and devices to serious injuries and even death. We have heard one horrific story after another. Women are suffering and crying over the phone while they no longer have money to pay for doctors to remove their mesh. They talk about tthe doctors hiding medical records and being lured by the pharmaceutical representatives. They talk of lives destroyed and marriages hurting. "When mommy hurts the whole family suffers" as one women told us.

Metal On Metal Hip Replacements like the DePuy and Zimmer
Women are reporting more problems, and a higher failure rate, with the DePuy ASR XL Acetabular hip replacement system than men. It turns out they're also more prone to some of the serious side effects of the poorly-designed implant, including metallosis.
Statistics show individuals with a small stature, such as women may be more susceptible to failure of DePuy ASR hip implants. Again we see women effected and mostly our senior population.

.
Dow Corning Breast Implants
Breast Implant Lymphoma
In January 2011, The U.S. Food & Drug Administration (FDA) advised that women who had received breast implants should notify their doctors of any changes in their breasts because of a possible association with a rare type of lymphoma. In breast implant patients, ALCL has occurred in the scar capsule adjacent to the implant. Women are still involved in settlements with Dow Corning trust.

Women appear to be money mills for pharmaceutical companies that are not using appropriate warnings or testing.

Bowel perforation From vaginal mesh can Be life Threatening, Wrongful Death Vaginal mesh lawyers

Written by Vaginal Mesh Helpline on May 14, 2012. Posted in Vaginal Mesh Information

The vaginal mesh has been creating complications of huge proportions in women in the United States. The Mesh can perforate the bowel. This is extremely serious as it can cause one to become septic and lead to potential death.

Symptoms of a perforated bowel

Perforation of the intestine leads to leakage of intestinal contents into the abdominal cavity. This can cause a woman to become septic from bacteria.

Symptoms may include:

Abdominal pain – severe
Chills
Fever
Nausea
Vomiting

Symptoms of Sepsis for the Mayo Clinic

Symptoms

By Mayo Clinic staff

Many doctors view sepsis as a three-stage syndrome, starting with sepsis and progressing through severe sepsis to septic shock. The goal is to treat sepsis during its mild stage, before it becomes more dangerous.

Sepsis
To be diagnosed with sepsis, you must exhibit at least two of the following symptoms:

Fever above 101.3 F (38.5 C) or below 95 F (35 C)
Heart rate higher than 90 beats a minute
Respiratory rate higher than 20 breaths a minute
Probable or confirmed infection

Severe sepsis
Your diagnosis will be upgraded to severe sepsis if you also exhibit at least one of the following signs and symptoms, which indicate organ dysfunction:

Areas of mottled skin
Significantly decreased urine output
Abrupt change in mental status
Decrease in platelet count
Difficulty breathing
Abnormal heart function

Septic shock
To be diagnosed with septic shock, you must have the signs and symptoms of severe sepsis, plus extremely low blood pressure. You must get emergency medical attention immediately.

Vaginal mesh Complications include:

Symptoms of Defective Vaginal Mesh Injury
Defective Vaginal Mesh Lawyers

If you have had surgery to correct pelvic organ prolapse (POP) or stress urinary incontinence (SUI), your surgeon may have used vaginal mesh. Defective vaginal mesh can cause serious injuries and life-threatening infections. If you are experiencing symptoms of defective vaginal mesh injury, talk to your doctor immediately and contact our defective vaginal mesh lawyers.
Vaginal Mesh Injury Symptoms

Symptoms of vaginal mesh injury include:

Vaginal infections
Urinary tract infections
Foul odor from surgical area
continupus infections
bowel perforation
Fever
Feeling as if something is protruding from the vagina
Chronic vaginal drainage or discharge
Pain during intercourse
Chronic pain
Bleeding
Urine leakage
Recurring abdominal pressure
Lower back pain
Difficult bowel movements
Mesh erosion
Recurrence of dropped organs
Bladder outlet obstruction

Dangers of Vaginal Mesh Injury

These symptoms can indicate infection and/or perforation of organs such as the bladder or bowel. Vaginal mesh injury is a medical emergency. If treatment is delayed, the infection can progress to sepsis which is often fatal.

Possibly the most dangerous vaginal mesh injury is bowel perforation. Bowel perforation can lead to sepsis and death very quickly.

What is Sepsis ?

Sepsis is a condition in which the body is fighting a severe infection that has spread via the bloodstream. If a patient becomes "septic," they will likely have low blood pressure leading to poor circulation and lack of perfusion of vital tissues and organs. This condition is termed "shock." This condition can develop either as a result of the body's own defense system or from toxic substances made by the infecting agent (such as a bacteria, virus, or fungus).

What is a perforated bowel ?

A perforated bowel is a medical emergency in which a hole in the bowel opens to allow its contents to empty into the rest of the abdominal cavity. The result is frequently sepsis or blood infection, which if not treated can cause almost immediate death. A perforated bowel can occur as the result of traumatic injury.

Symptoms of a perforated bowel include high fever and nausea. Those afflicted will also experience extreme abdominal pain which worsens when one moves. Intense vomiting may occur and result in dehydration. These very serious symptoms need emergency treatment. Those experiencing these symptoms should waste no time in seeing by a doctor. If you are experiencing mesh erosion you must understand the the mesh can perforate the bowel. You must not delay in seeking medical attention.

Seek legal action

If you think your mesh is causing a bowel perforation see a urogynecologist to remove the mesh or have some kind of revision surgery.

Once the Physician conforms the mesh has created a problem call the vaginal Mesh helpline to be connceted th a Vaginal mesh lawyer.

Vaginal Mesh Lawsuit Statute of LImitations Alert, Vaginal Mesh lawyers

Written by Vaginal Mesh Helpline on May 12, 2012. Posted in Vaginal Mesh News

Vaginal mesh Helpline Statute of limitations alert for your filing your vaginal mesh lawsuit. A Vaginal mesh lawyer must be contacted immediately to protect your legal rights in the vaginal mesh lawsuits taking place right now in multi district litigations. You must act to protect your rights.

Vaginal Mesh helpline alerts you not to wait on filing your vaginal mesh lawsuit. Contact a vaginal mesh lawyer immediately that is filing the multi district litigation lawsuit for vaginal mesh in the federal courts. The lawyer must be filing this for you in the court assigned for that manufacturer. The complete list of staute of limitations is listed below

Contact the VaginalMesh helpline for a list of vaginal Mesh lawyers filing lawsuits for women with vaginal mesh Complications. You should not wait. There are statutes of limitations for your state that can effect your filing in the future:

Statute of limitations By State

Contact a vaginal mesh lawyer to find out how this effects your vaginal mesh lawsuit today

Florida (4 years), Missouri (5 years), Nebraska (4 years), North Dakota (6 years), Utah (4 years) and Wyoming (4 years)

3 year SOL States D.C., Maryland, Massachusetts, Michigan, Mississippi, Montana, New Hampshire, New Mexico, North Carolina, Rhode Island, South Carolina, Vermont, Washington & Wisconsin

1 year (Kentucky, Louisiana & Tennessee)

non-discovery states (Arkansas, Indiana, Maine, New York & South Dakota)

Complications we hear on a daily basis appear to be very similiar, You are not alone

Erosion of the mesth thru the vagina wall, " My Partner can feel it"
Infections that doctors are not relating to the mesh " Ihave infections all the time"
partner feeling the mesh during sexual intercourse "He can feel it"
Bladder and urinary tract infections "I have been on antibiotics for months"
blood in urine
pain like a razor blade "the pain is agony"
activities of daily life limited
depression "My life is over"
inability to work "I lost my job and insurance"
reported deaths "mu grandma died for the vaginal mesh""I want to do something"
Spot bleeding
lower back pain
leg and pain on one side of the body " the pain is terrible"
severe agonizing pain
Inability to have sexual intercourse "I cannot have sex anymore"
partners feeling the mesh "he feels it"
feeling pieces of the mesh " I can feel it with my finger"
doctors unsympathetic" my doctor tell me it is all in my head"

You must see a Urogynecologist for your medical condition immediately and have a doctor acknowledge it is from the mesh. Many women are reporting that the Doctor who put in the mesh is not helpling. This is no suprise. Call the vaginal mesh helpline at 1 877 522-2123 vaginameshhelpline.com for help

You must not wait a retain an attorney immediately.

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First Vaginal mesh Trials Set in New Jersey, Vaginal Mesh lawyers Ready

Written by Vaginal Mesh Helpline on May 4, 2012. Posted in Vaginal Mesh News

Vaginal mesh lawyers reviewing cases for First federal vaginal mesh court trials in 2013. First 600 Bard Avaulta Vaginal Mesh lawsuits.

C.R. Bard Inc. will face its first federal-court trial in 2013 over claims that the company’s vaginal-mesh implants injured women. U.S. District Judge Joseph R. Goodwin in Charleston, West Virginia, set a Feb. 5 trial date for the first of about 600 Bard Avaulta mesh federal cases. The plaintiffs are alleging that Bard’s Avaulta device caused pelvic organ damage.

The West Virgina court is overseeing the MDL consolidation of cases filed in federal courts across the U.S. against Bard, Johnson &
FDA Mesh Warning

A U.S. Food and Drug Administration report in August 2011 found that vaginal-mesh products should be classified as posing a high risk to patients based on a review of side-effect reports submitted to regulators from January 2008 to December 2010.

FDA Demands More Study

In January, the FDA ordered 31 manufacturers, including Bard and J&J (JNJ), to study rates of organ damage and complications linked to the vaginal-mesh implants.

According to regulators, the companies must conduct three years of studies on the devices’ safety and effectiveness.

New Jersey Vaginal Mesh Lawsuits Pending in New Jersey

Some mesh lawsuits are pending in state court in Atlantic City, New Jersey. Superior Court Judge Carol Higbee is coordinating discovery in those cases.

Higbee has set a Nov. 5 trial for the first case against J&J’s Ethicon unit over claims that its Gynecare Prolift vaginal-mesh insert harmed women.

West Virginia Vaginal Mesh Federal MDL (Multi District Litigation)

In February, the Judicial Panel on Multidistrict Litigation consolidated federal suits against pelvic mesh makers before Goodwin. The federal court is overseeing evidence-gathering efforts in cases against Bard, J&J, Boston Scientific Corp. (BSX) and the American Medical Systems unit of Endo Pharmaceutical Holdings Inc.

The Bard consolidated cases are In re C.R. Bard Inc. Pelvic Repair System Products Liability Litigation, 2:10-MD-02187, U.S. District Court, Southern District of West Virginia (Charleston).

Vaginal mesh Helpline lawyers Accepting vaginal mesh cases.

Bard vaginal Mesh lawsuits to Begin in West Virginia, Bard Vaginal mesh Lawyers Acepting cases

Written by Vaginal Mesh Helpline on May 3, 2012. Posted in Vaginal Mesh News

The vaginal mesh lawyers are Filing Bard vaginal mesh cases In West Virginia under the Vaginal mesh Multi District litigation. That means nomatter what state you are in your Bard Vaginal mesh lawsuit will end up in West Virginia. In an MDL the cases are all filed on an individual basis but get consolidated under one Judge, in this case a Judge in West Virginia. This means that you do not need or necessarily hire a local lawyer in your state but rather a lawyer or law firm experienced in MDL litigation of the Vagina Mesh. Most local lawyers are going to send your case to "the big boys" anyway. For a Bard Vaginal mesh Lawyer call the vaginal Mesh helplinbe today. The Bard trial will be for the Bard Avaulta vaginal mesh and include 600 women damaged by the mesh implant. The vaginal mesh cases are Federal cases.

C.R. Bard Inc. will face its first federal-court trial next year over claims that the company’s vaginal-mesh implants injured women.

U.S. District Judge Joseph R. Goodwin in Charleston, West Virginia, set a Feb. 5 trial date for the first of about 600 federal cases contending that Bard’s Avaulta device caused organ damage. Goodwin is overseeing a consolidation of cases filed in federal courts across the U.S. against Bard, Johnson & Johnson and other makers of vaginal-mesh inserts.

The order of trials for the first federal cases over Avaulta “will be determined after completion” of pretrial information exchanges between Bard and the plaintiffs, Goodwin said in his order yesterday.

Bard, based in Murray Hill, New Jersey, and a unit of New Brunswick, New Jersey-based J&J also face litigation in U.S. state courts over their mesh products. More than 75,000 women a year have the devices inserted vaginally to treat pelvic organs that bulge, or prolapse, or to deal with incontinence.

Scott Lowry, a Bard spokesman, didn’t immediately return a call for comment on the judge’s decision to set the trial date.

More Study

In January, the FDA ordered 31 manufacturers, including Bard and J&J (JNJ) to study rates of organ damage and complications linked to the vaginal-mesh implants. The companies must conduct three years of studies on the devices’ safety and effectiveness, regulators said. Some women contend the devices eroded and shrank over time, causing pain and injuries.

Some mesh suits blaming Bard and J&J for injuries are pending in state court in Atlantic City, New Jersey. Superior Court Judge Carol Higbee is coordinating discovery in those cases. Higbee has set a Nov. 5 trial for the first case against J&J’s Ethicon unit over claims that its Gynecare Prolift vaginal-mesh insert harmed women.

In February, the Judicial Panel on Multidistrict Litigation consolidated federal suits against pelvic mesh makers before Goodwin. The judge is overseeing evidence-gathering efforts in cases against Bard, J&J, Boston Scientific Corp. (BSX) and the American Medical Systems unit of Endo Pharmaceutical Holdings Inc.

Endo’s AMS unit also faces claims in state courts in Delaware and Minnesota over its Perigee, Apogee and Elevate surgical mesh products, according to court filings.

‘Day In Court’

Goodwin has appointed Bryan Aylstock, Fred Thompson III and Henry G. Garrard III to lead a group of plaintiffs’ lawyers who will oversee the progress pretrial information exchanges over the consolidated federal cases.

Aylstock, a Pensacola, Florida-based lawyer, said he was pleased Goodwin set the first trial over Bard’s mesh product for early next year.

“We have a lot of women who have suffered devastating consequences from the Avaulta product and they deserve their day in court,” the plaintiffs’ lawyer said in a telephone interview.

The Bard consolidated cases are In re C.R. Bard Inc. Pelvic Repair System Products Liability Litigation, 2:10-MD-02187, U.S. District Court, Southern District of West Virginia (Charleston).

To contact the reporters on this story: Jef Feeley in Wilmington, Delaware

Vaginal mesh Information, Vaginal mesh lawyers

Written by Vaginal Mesh Helpline on May 2, 2012. Posted in Vaginal Mesh News

A resource for women with Vaginal mesh, helping women with Mesh complications and assisting with a Urogynecologist and Vaginal Mesh lawyer We are always seeking new information for our women of the Vaginal Mesh.

Summary and Overview

FDA Alert – Using surgical mesh for prolapse surgery

FDA safety communication: UPDATE on serious complications associated with transvaginal placement of surgical mesh for pelvic organ prolapse. Vaginal Mesh lawyers are acepting cases for a Multi District litigation

What is a Vaginal Mesh ?

Surgical mesh is a medical device that is generally used to repair weakened or damaged tissue. It is made from porous absorbable or non-absorbable synthetic material or absorbable biologic material. In urogynecologic procedures, surgical mesh is permanently implanted to reinforce the weakened vaginal wall to repair pelvic organ prolapse or to support the urethra to treat urinary incontinence.

More About the vaginal mesh, The Vaginal Mesh is Used for

Pelvic Organ Prolapse
Pelvic organ prolapse (POP) occurs when the tissues that hold the pelvic organs in place become weak or stretched. Thirty to fifty percent of women may experience POP in their lifetime with 2 percent developing symptoms. When POP happens, the organs bulge (prolapse) into the vagina and sometimes prolapse past the vaginal opening. More than one pelvic organ can prolapse at the same time. Organs that can be involved in POP include the bladder, the uterus, the rectum, the top of the vagina (vaginal apex) after a hysterectomy, and the bowel.

Stress Urinary Incontinence
Stress urinary incontinence (SUI) is a leakage of urine during moments of physical activity, such as coughing, sneezing, laughing, or exercise.

FDA Notices and Warnings

On Oct. 20, 2008, the FDA issued a Public Health Notification and Additional Patient Information on serious complications associated with surgical mesh placed through the vagina (transvaginal placement) to treat POP and SUI.
Based on an updated analysis of adverse events reported to the FDA and complications described in the scientific literature, the FDA identified surgical mesh for transvaginal repair of POP as an area of continuing serious concern.

The FDA is issuing this update to inform you that serious complications associated with surgical mesh for transvaginal repair of POP are not rare. This is a change from what the FDA previously reported on Oct. 20, 2008. Furthermore, it is not clear that transvaginal POP repair with mesh is more effective than traditional non-mesh repair in all patients with POP and it may expose patients to greater risk. This Safety Communication provides updated recommendations for health care providers and patients and updates the FDA’s activities involving surgical mesh for the transvaginal repair of POP.
The FDA continues to evaluate the effects of using surgical mesh to repair SUI and will communicate these findings at a later date.

For detailed information, please see: Urogynecologic Surgical Mesh: Update on the Safety and Effectiveness of Transvaginal Placement for Pelvic Organ Prolapse.

Overview of the Vaginal mesh

In the Oct. 20, 2008 FDA Public Health Notification, the number of adverse events reported to the FDA for surgical mesh devices used to repair POP and SUI for the previous 3-year period (2005 – 2007) was “over 1,000.” Since then, from Jan. 01, 2008 through Dec. 31, 2010, the FDA received 2,874 additional reports of complications associated with surgical mesh devices used to repair POP and SUI, with 1,503 reports associated with POP repairs and 1,371 associated with SUI repairs. Although it is common for adverse event reporting to increase following an FDA safety communication, we are concerned that the number of adverse event reports remains high.
From 2008 – 2010, the most frequent complications reported to the FDA for surgical mesh devices for POP repair include mesh erosion through the vagina (also called exposure, extrusion or protrusion), pain, infection, bleeding, pain during sexual intercourse (dyspareunia), organ perforation, and urinary problems. There were also reports of recurrent prolapse, neuro-muscular problems, vaginal scarring/shrinkage, and emotional problems. Many of these complications require additional intervention, including medical or surgical treatment and hospitalization.

In order to better understand the use of surgical mesh for POP and SUI, the FDA conducted a systematic review of the published scientific literature from 1996 – 2011 to evaluate its safety and effectiveness. The review showed that transvaginal POP repair with mesh does not improve symptomatic results or quality of life over traditional non-mesh repair. The FDA continues to evaluate the literature for SUI surgeries using surgical mesh and will report about that usage at a later date.

In particular, the literature review revealed that:

Mesh used in transvaginal POP repair introduces risks not present in traditional non-mesh surgery for POP repair.
Mesh placed abdominally for POP repair appears to result in lower rates of mesh complications compared to transvaginal POP surgery with mesh.
There is no evidence that transvaginal repair to support the top of the vagina (apical repair) or the back wall of the vagina (posterior repair) with mesh provides any added benefit compared to traditional surgery without mesh.
While transvaginal surgical repair to correct weakened tissue between the bladder and vagina (anterior repair) with mesh augmentation may provide an anatomic benefit compared to traditional POP repair without mesh, this anatomic benefit may not result in better symptomatic results.

The FDA’s literature review found that erosion of mesh through the vagina is the most common and consistently reported mesh-related complication from transvaginal POP surgeries using mesh. Mesh erosion can require multiple surgeries to repair and can be debilitating for some women. In some cases, even multiple surgeries will not resolve the complication.

Mesh contraction (shrinkage) is a previously unidentified risk of transvaginal POP repair with mesh that has been reported in the published scientific literature and in adverse event reports to the FDA since the Oct. 20, 2008 FDA Public Health Notification. Reports in the literature associate mesh contraction with vaginal shortening, vaginal tightening and vaginal pain.
Both mesh erosion and mesh contraction may lead to severe pelvic pain, painful sexual intercourse or an inability to engage in sexual intercourse. Also, men may experience irritation and pain to the penis during sexual intercourse when the mesh is exposed in mesh erosion.

The complications associated with the use of surgical mesh for POP repair have not been linked to a single brand of mesh.

Recommendations for Health Care Providers:

As stated in the Oct. 20, 2008 Public Health Notification, the FDA continues to recommend that health care providers should:

Obtain specialized training for each mesh placement technique, and be aware of the risks of surgical mesh.
Be vigilant for potential adverse events from the mesh, especially erosion and infection.
Watch for complications associated with the tools used in transvaginal placement, especially bowel, bladder and blood vessel perforations.
Inform patients that implantation of surgical mesh is permanent, and that some complications associated with the implanted mesh may require additional surgery that may or may not correct the complication.
Inform patients about the potential for serious complications and their effect on quality of life, including pain during sexual intercourse, scarring, and narrowing of the vaginal wall in POP repair using surgical mesh.
Provide patients with a copy of the patient labeling from the surgical mesh manufacturer if available.

In addition, the FDA also recommends that health care providers:

Recognize that in most cases, POP can be treated successfully without mesh thus avoiding the risk of mesh-related complications.
Choose mesh surgery only after weighing the risks and benefits of surgery with mesh versus all surgical and non-surgical alternatives.
Consider these factors before placing surgical mesh:
- Surgical mesh is a permanent implant that may make future surgical repair more challenging.
- A mesh procedure may put the patient at risk for requiring additional surgery or for the development of new complications.
- Removal of mesh due to mesh complications may involve multiple surgeries and significantly impair the patient’s quality of life. Complete removal of mesh may not be possible and may not result in complete resolution of complications, including pain.
- Mesh placed abdominally for POP repair may result in lower rates of mesh complications compared to transvaginal POP surgery with mesh.
Inform the patient about the benefits and risks of non-surgical options, non-mesh surgery, surgical mesh placed abdominally and the likely success of these alternatives compared to transvaginal surgery with mesh.
Notify the patient if mesh will be used in her POP surgery and provide the patient with information about the specific product used.
Ensure that the patient understands the postoperative risks and complications of mesh surgery as well as limited long-term outcomes data.

Recommendations for Patients:

Before Surgery

Be aware of the risks associated with surgical mesh for transvaginal repair of POP. Know that having a mesh surgery may put you at risk for needing additional surgery due to mesh-related complications. In a small number of patients, repeat surgery may not resolve complications.
Ask your surgeon about all POP treatment options, including surgical repair with or without mesh and non-surgical options, and understand why your surgeon may be recommending treatment of POP with mesh.

In addition, ask your surgeon these questions before you agree to have surgery in which surgical mesh will be used:

Are you planning to use mesh in my surgery?
Why do you think I am a good candidate for surgical mesh?
Why is surgical mesh being chosen for my repair?
What are the alternatives to transvaginal surgical mesh repair for POP, including non-surgical options?
What are the pros and cons of using surgical mesh in my particular case? How likely is it that my repair could be successfully performed without using surgical mesh?
Will my partner be able to feel the surgical mesh during sexual intercourse? What if the surgical mesh erodes through my vaginal wall?
If surgical mesh is to be used, how often have you implanted this particular product? What results have your other patients had with this product?
What can I expect to feel after surgery and for how long?
Which specific side effects should I report to you after the surgery?
What if the mesh surgery doesn’t correct my problem?
If I develop a complication, will you treat it or will I be referred to a specialist experienced with surgical mesh complications?
If I have a complication related to the surgical mesh, how likely is it that the surgical mesh could be removed and what could be the consequences?
If a surgical mesh is to be used, is there patient information that comes with the product, and can I have a copy?

After Surgery

Continue with your annual and other routine check-ups and follow-up care. There is no need to take additional action if you are satisfied with your surgery and are not having complications or symptoms.

Notify your health care provider if you have complications or symptoms, including persistent vaginal bleeding or discharge, pelvic or groin pain or pain with sex, that last after your follow-up appointment.

Let your health care provider know you have surgical mesh, especially if you plan to have another surgery or other medical procedures.
Talk to your health care provider about any questions you may have.
If you had POP surgery, but do not know whether your surgeon used mesh, ask your health care provider at your next scheduled visit.

FDA Activities:

The FDA is working in several areas to assess and improve the safety and effectiveness of urogynecologic mesh products. The FDA will:
Convene the Obstetrics-Gynecology Devices Panel of the Medical Device Advisory Committee, on September 8-9, 2011.The panel will discuss and make recommendations regarding the safety and effectiveness of transvaginal surgical mesh for POP and SUI.

Explore regulatory solutions to answer questions about the safety and effectiveness of urogynecologic mesh products that are now being marketed and those that will be reviewed for marketing in the future.

Continue to monitor adverse events reported to FDA associated with surgical mesh used to repair POP and SUI, as well as assessing any and all data as it becomes available.

Reporting Problems to the FDA:

Prompt reporting of adverse events can help the FDA identify and better understand the risks associated with medical devices. If you suspect a problem with surgical mesh, we encourage you to file a voluntary report through MedWatch, the FDA Safety Information and Adverse Event Reporting program. Health care personnel employed by facilities that are subject to the FDA's user facility reporting requirements should follow the reporting procedures established by their facilities. Device manufacturers must comply with the Medical Device Reporting (MDR) regulations.

To help us learn as much as possible about the adverse events associated with surgical mesh to repair POP and SUI, please include the following information in your reports, if available:
Manufacturer's name
Product name (brand name)
Catalog number
Lot number
Size
Date of implant
Date of explant (if mesh was removed)
Details of the adverse event and medical and/or surgical interventions (if required)
Type of procedure (e.g., anterior or posterior repair, sacral colpopexy, sling procedure for SUI)
Surgical approach: (e.g., vaginal, abdominal, laparoscopic)
Reason for mesh implantation: (e.g., POP of the uterus, bladder, rectum, vaginal apex or bowel, SUI)
Specific postoperative symptoms experienced by the patient with time of onset and follow-up treatment

Additional Contact Information:
If you have questions about this communication, please contact the Division of Small Manufacturers, International and Consumer Assistance (DSMICA) at 800-638-2041 or 301-796-7100.
This document reflects the FDA’s current analysis of available information, in keeping with our commitment to inform the public about ongoing safety reviews of medical devices.

New Vaginal mesh Guidelines, Vaginal mesh helpline reports

Written by Vaginal Mesh Helpline on May 2, 2012. Posted in Vaginal Mesh News

Transvaginal Mesh Guidelines Created by AHRQ Ignored by FDA
April 27, 2012 Posted by: Barb Stephens

The vaginal mesh helpline and Vaginal mesh lawyers are happy to see the AHRQ has released guidelines for Mesh Surgery. Women call daily with severe complications from their vaginal mesh implant. The FDA has offered nothing. Even with the guidelines the horrors of the Vaginal mesh cannot be denied.From listening to women every day it is becoming obvious that the transvaginal mesh is dangerous. Women nationwide have filed lawsuits against several vaginal mesh manufacturers, including Johnson and Johnson and Boston Scientific. Hundreds of these cases have been consolidated in a multidistrict litigation (MDL) in the West Virginia district court.It appears that many more will be added over the next months yet doctors are still putting the mesh in women. Many women call our helpline just months after their surgery with severe discomfort and complications.

Even before the U.S. Food and Drug Administration (FDA) issued warnings against the continued use of transvaginal mesh in patients suffering from pelvic organ prolapse, another governmental agency set its sights on the faulty medical device.The U.S. Agency for Healthcare Research and Quality (AHRQ), which is a branch of the U.S. Department of Health and Human Services, released guidelines for patients considering having the questionable medical device implanted. The guidelines also remind doctors that transvaginal mesh is a new procedure and should be used with caution.
The agency, formerly known as the Agency for Health Care Policy and Research, is the research arm of health and human services. It acts as a regulatory agency for patient safety organizations. In its guidelines for utilizing transvaginal mesh, the agency recommended that doctors, surgeons and nurses be adequately trained in using the device to fix pelvic prolapse before implanting it.

Pelvic prolapse is known to occur in women who are past menopause and childbearing years or who have had a hysterectomy. Because of weakened muscles, the pelvic organs, including the uterus and rectum, can slip into the vagina and cause a host of problems. Agency for Healthcare Research and Quality

Doctors were using transvaginal mesh to fix the problem, but many now realize the all of the transvaginal mesh devices on the market are modeled after one that is faulty in design. This faulty design results in mesh erosion.

Because of this, thousands of women are suffering from injuries that include bleeding, immense pain and punctured internal organs. Many women are forced to have the mesh removed in an attempt to lead a normal, pain-free life.

The FDA’s response to transvaginal mesh has been shoddy at best. In 2008, the agency downplayed patient’s complaints about the mesh, saying problems with it is rare.

Three years later, the FDA did a rare reversal and said that problems with the device are “not rare.” However, nothing has been done to regulate the faulty devices or the manufacturers.

In the years between the two FDA decisions, the AHRQ came out with its guidelines for patients. The agency said patients need to be aware of several issues:

Transvaginal mesh is considered new way to treat pelvic prolapse, thus not proven.
Success rates vary.
There is little information about long-term use.
Serious complications could result from mesh.
Little data exists that transvaginal mesh will actually fix a prolapse problem.
Patients should undergo thorough pre-operative counseling regarding the limited data that exists about the device.

With the mounting medical evidence showing that transvaginal mesh is dangerous, women nationwide have filed court complaints against several mesh manufacturers, including Johnson and Johnson and Boston Scientific. Hundreds of the cases have been consolidated in a multidistrict litigation (MDL) in a West Virginia district court. Contact the Vaginal Mesh helpline to get the facts, get help locating a Doctor for Mesh removal and be connected to an experienced vaginal mesh , mass tort lawyer.

Vaginal Mesh lawyers Filing Lawsuits For Vaginal, Vaginal Mesh Helpline Reports

Written by Vaginal Mesh Helpline on April 30, 2012. Posted in Vaginal Mesh Stories, Vaginal Mesh lawyers

Lawsuits are being Filed by transvaginal mesh lawyers on behalf of women with vaginal mesh complications. Vaginal mesh helpline Keeps women updated on new news regarding the Vaginal Mesh. According to Lisa Spitzer MSW "we must continue to give women hope that they will obtain justice for ruined lives due to these vaginal mesh complications. The pain and suffering is horrific"

New Lawsuit Filed on Trasvaginal Mesh Serious Complications: the Threat of Severe Adverse Events from Transvaginal Mesh Remains
According to court documents, on April 10th, 2012 an Illinois woman, a Vaginal meshh lawyer , filed a lawsuit in West Virginia Southern District Court (case no. 2:2012cv01025) alleging she suffered a multitude of medical problems as a result of a transvaginal mesh surgery to treat a pelvic organ prolapse (POP). Plaintiff was surgically implanted with the Pelvitex polypropylene vaginal mesh system and she is suing Bard Healthcare, a division of C.R. Bard, Inc., et al for nearly $10 million in damages. Transvaginal surgical mesh is used to treat pelvic organ prolapse (POP) and Stress Urinary Incontinence (SUI). Several lawsuits against C.R. Bard were consolidated in October 2010 as part of an MDL (No.2187) in the US District Court for the Southern District of West Virginia. Vaginal Mesh helpline can provide helpful, proven advice and simple solutions including how to get in contact a vaginal mesh lawyer so anyone can easily and inexpensively deal with cases of Transvaginal Mesh horrors.

The vaginal mesh Helpline Speaks to women daily regarding their mesh complications and hears many stories. Many are very similiar, inability to have sexual intercourse, severe pain, mesh erosion thru the vaginal wall, spot bleeding, infections, pain on one side of the body,

lower back pain, and Doctors being unsympathetic to the problems they are having. We speak to women from Florida to California and as far north as Canada. "The stories are horrific and women are truly suffering. We are here to help" Says spitzer.

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