Posts Tagged ‘Maine’

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

Written by Vaginal Mesh Helpline on . 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.
 

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

Written by Vaginal Mesh Helpline on . 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 . 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.

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

Written by Vaginal Mesh Helpline on . 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 . 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.
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. Women’s groups are demanding that the devices be recalled.

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

 

What does My State’s Statute of Limitations Mean ?

Written by Vaginal Mesh Helpline on . Posted in Vaginal Mesh News

Statue of Limitations and discovery rule for Vaginal Mesh lawsuits 
It is different in different states.  Florida has what is called the discovery rule which essentially starts the statute when you know that you are injured and that the injury is probably caused by someone’s negligence.  Not all states have discovery rule and the statute will run from the date that the injury occurred (implantation or when the mesh started causing problems).
2008 becomes important when mesh was implanted and caused symptoms before 2008.  But argument can be made that the warning and associated press was not sufficient to put a person on notice of the relationship between the mesh and the injury.  Heck some doctors are still telling women that it is not the mesh causing problems but something else (like a tumor).  And many doctors are still putting the prolene mesh in women.
 
Vaginal Mesh Lawsuit Dismissed After Statute of Limitations Expires

 

 

 

A federal judge has dismissed a vaginal mesh lawsuit after determining that it was barred by Georgia’s two-year statute of limitations. Tami Goodson filed her suit in July of 2011, alleging that she had been injured by a vaginal mesh product manufactured by Boston Scientific Corporation.
Plaintiff alleged many transvaginal mesh problems

Goodson had Boston Scientific’s Pinnacle Pelvic Floor System and a Prefyx Pre-Pubic Sling implanted in 2008, following a hysterectomy and vaginal reconstruction surgery. In March of 2009, Goodson claims to have developed transvaginal mesh problems. She had a second surgery to trim the mesh, which was protruding into her vagina. She returned for a third surgery in July of 2009, as a result of chronic pain and stress urinary incontinence, also associated with her transvaginal mesh problems.

Goodson’s complaint — which concerned only her individual case and which was not part of a larger vaginal mesh class action lawsuit — alleged that Boston Scientific had been negligent in its production of the mesh product that was implanted in her.
Transvaginal mesh problems lawsuit filed too late

In his order dismissing Goodson’s lawsuit, Judge Thomas W. Thrash Jr. of the U.S. District Court for the Northern District of Georgia found that the plaintiff should have filed her case by March of 2011, within two years of the time she first experienced transvaginal mesh problems.

Though Goodson alleged that she did not know of her transvaginal mesh problems until July of 2009, the judge found that her second surgery, in March of 2009, should have alerted her to the problems.

Though the starting point for Georgia’s two-year statute of limitations for personal injury actions can be tolled (extended) until a plaintiff discovers (or should have discovered) her injury, the judge found no justification for tolling in the plaintiff’s case.
Vaginal mesh lawyer fails to allege sufficient facts

The judge also found that Goodson’s lawsuit complaint did not contain sufficient facts to support her argument that the device was defective. Though initial pleadings, such as complaints, are generally construed liberally, the plaintiff must at least allege the basic facts that support his or her cause of action.

Here, the judge found that Goodson’s complaint contained mere legal conclusions unsupported by factual allegations in regard to her transvaginal mesh problems. Because Goodson’s suit was not part of a larger vaginal mesh class action lawsuit, the judge’s December 29, 2011 ruling does not affect any other plaintiffs.

Time to File Depends on the Date of Injury

Statutes of limitations are state laws that require plaintiffs to file their cases within set time periods. Because all defective medical device lawsuits are tort claims, they are covered by state law and not federal law. Any medical device lawsuits before U.S. District Courts are claims brought under state law by plaintiffs from states other than the ones in which the manufacturers are located. The purpose of statutes of limitations is to encourage injured parties to bring their claims in a timely manner to prevent courts from dealing with old records and hazy memories.

Statute of Limitations Confusing

Because statute of limitations can be confusing, many women believe that they are not able to file a vaginal mesh lawsuit. Unfortunately, there’s not one set answer when it comes to vaginal mesh. Several factors may influence vaginal mesh statute of limitations, including the date of your initial surgery, the mesh removal date if you had it surgicall removed, the state the U.S. Food & Drug Administration (FDA) issued a warning, when you may have had conversations with your doctor or when you started noticing symptoms.

The amount of time a statute of limitations gives someone to file a claim depends on the type of claim the plaintiff is filing. Commonly, the limitations period for products liability cases is two or three years from the date of injury. When the injury occurred matters significantly from a legal standpoint. Sometimes, the injury “occurs” the day the vaginal mesh was implanted; other times it “occurs” when the plaintiff first knew or could have reasonably found out about the injury. This can be troubling for vaginal mesh recipients because the pain and symptoms of mesh erosion might not occur until long after the initial procedure. Because some women might have already had their vaginal mesh problems resolved years ago and didn’t meet with a transvaginal mesh lawyer, the statute of limitations might have already expired for them, and they will be unable to obtain compensation via a transvaginal mesh lawsuit.

Do not wait to file a Vaginal Mesh Lawsuit

A vaginal mesh lawsuit, like any legal claim, is a time sensitive matter that must be filed within the applicable statute of limitations.  Statutes of limitations create very strict deadlines within which individuals must file their claims or forever waive their right to a day in court.  The statutes may be narrowed even further by a “discovery rule” which can create an additional time sensitive hurdle to overcome.

A Vaginal Mesh lawyer can help with these matters of law and make sure that your  lawsuit is filed timely.  However, a prompt Vaginal Mesh lawsuit evaluation is vital to this process.

Statutes of limitation vary from state to state.  Some statutes expire within 6 months; others allow as much as 3 years to file a claim. Hesitation may cost a potential litigant his or her day in court. Therefore, potential litigants should consider receiving a Vaginal Mesh lawsuit evaluation at their earliest convenience.

Many legal professionals will offer a free Vaginal Mesh lawsuit evaluation to help expedite the commencement of litigation.  Don’t let the time to file a claim against the responsible manufacturer lapse. Time is of the essence.

What is a discovery Rule ?

Discovery Rule

In certain situations it is impossible  for a person who has suffered an injury to know what caused their injury until a much later date, sometime years. For example, a woman who developed side effects after surgery, but did not know that it may have caused the side effects. The discovery rule typically applies in negligence cases.  As such, the time to file suit doesn’t begin (or accrue) until a person realizes he has been injured. The discovery rule is a common law doctrine that often applies to cases in which a statute of limitations is involved. A statute of limitations is a set period of time in which a lawsuit is considered reasonable; once beyond this set period of, a party that wants to sue may have no legal recourse. The discover rule suggests that the statute of limitations begins, not at the time of the unlawful event, but rather from the time that the suing party became aware of the breech. The discovery rule is unevenly applied, and may be discarded by judges who disagree with the claim.

The discovery rule is important because unlawful acts do not always have immediately known or foreseeable consequences. If a worker is unknowingly exposed to harmful chemicals, leading him or her to develop a serious medical disease ten years later, the discovery rule suggests that the statute of limitations on suing a negligent employer would begin when the illness was first detected, not at the time of the unwitting exposure. Medical cases such as this frequently employ the discovery rule to call for an adjustment of the statutes of limitations on issues such as malpractice or employer negligence.

In a Negligence case like a vaginal mesh case the Discovery rule or lack of can determine when the statue begins or the clock stats ticking. If you are in a non discovery rule state you should not wait to see a doctor . You must move quickly.

The discovery rule can affect when the statute of limitations begins to run. In some cases, an injury that caused a wrongful death was not apparent when it first occurred; this is usually due to the nature of the injury itself. The statute of limitations will begin, then, at the time the injury is discovered or reasonably should have been discovered.

Consider a statute of limitations that is, for instance, two years long. Normally, the clock would start ticking as soon as the injury occurred. But if the injury is reasonably discovered one year after it occurs, the two-year period begins on the day of discovery.

In many states, there is an exception to statues of limitations which is called the “discovery rule.” Under the discovery rule, if for some reason at the time a personal injury occurred that you did not know a personal injury occurred, despite the exercise of reasonable diligence, then you have until two years (or whatever the statute of limitations period is) from the date that you discovered, or reasonably should have discovered that the personal injury occurred in which to file a lawsuit. It is important t be aware of whether or not your state has a discovery rule. In any event it is importnat to move quickly because the clock is ticking.

If you are in a state with no discovery rule it changes the whole scheme of things as to when the statute begins. It may boil down to the 2008 warning date or the 2011 warning date or the exact date your mesh was implanted. You must contact a vaginal mesh lawyer immediatley.

Not every state applies the discovery rule in the same way. How it is used also depends on the injury and other circumstances.

 

Vaginal mesh Information, Vaginal mesh lawyers

Written by Vaginal Mesh Helpline on . 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 . 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 . 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. 

Boston Scientific Class II Mesh Recall, Boston Scientific Vaginal Mesh lawyers

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

Vaginal Mesh Helpline ,Ladies of the Vaginal  Mesh Announcement: If appears that there has been an official recall of one of the Vaginal mesh Implants.

Boston Scientific issued a Class II recall of its Pinnacle pelvic floor repair kit  over the potential for the needle to detach from the mesh during placement. The device may expose patients to unnecessary risk without offering clinical benefit above safer options.

The product is used to treat pelvic organ prolapse, which occurs when internal organ support structures become so weak or stretched that organs, like the uterus, bladder or bowels, sag from their normal position and bulge or prolapse into the vagin

See the Fda Notice Below

Class 2 Recall
Pinnacle Pelvic Floor Repair Kit–Anterior/Apical, and Pinnacle Pelvic Floor Repair Kit–Posterior see related information
Date Posted  August 03, 2011
Recall Number  Z-2931-2011
Product  Pinnacle Pelvic Floor Repair Kit–Anterior/Apical STERILE, and Pinnacle Pelvic Floor Repair Kit–Posterior STERILE. Boston Scientific, Corp. Indicated for tissue reinforcement and stabilization of fascial structures of the pelvic floor for vaginal wall prolapse, where surgical treatment is intended, either as mechanical support or bridging material for the fascial defect.
Code Information  Catalog/UPC: M0068317100, Lot: 1ML0072001. Catalog/UPC M0068317050, Lot: 1ML0070801.
Recalling Firm/
Manufacturer  Boston Scientific Corporation
100 Boston Scientific Way
Marlborough, Massachusetts 01752-1234
Consumer Instructions  Contact the recalling firm for information
For Additional Information Contact  Cindy Finney
508-683-4678
Reason for
Recall  The device may exhibit low tensile strength between the needle and suture and lead to needle detachment during mesh leg placement.
Action  Boston Scientific Corporation sent on May 10, 2011 an "URGENT MEDICAL DEVICE RECALL-IMMEDIATE ACTION REQUIRED" letter to all affected customers. The letter included; reason for recall, instructions for the quarantine, discontinued use, and return of the devices, and information for Medwatch reporting. The letter also includes a form that is to be faxed to the firm. For information call (508) 683-4678