Posts Tagged ‘Pennsylvania’

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

 

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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.

 

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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.

 

 

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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.

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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. 

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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

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Planned Parenthood Speaks Out on Yaz, Just another Product Harming Women

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

Vaginal mesh helpline has Launched a Yaz Helpline for Women harmed by Yaz. Yaz now has been given orders by The FDA for increased warnings and Bayer si offering the first round of payoffs for yaz. yaz has complications such as: Stroke, blood clots, Deep vein thrombosis, Pulmonary embolism, and even death. At Vaginal mesh Helpline we are concerned about all drugs and medical dsevices harming women and will continue to keep our followers informed about all neew developements. Our research has shown that Yaz was being given out by Planned Parenthood in many states esecially to lower income families as a form of birth control. Wer found comments from the executive director of planned parenthood on Yaz:

d Clot Warning Added To Birth Control Pills Like Yaz: What To Know
10 days ago by Briana Rognlin | 5 Comments | Share a Tip

birth control blood clot warningsThe Food and Drug Administration announced earlier this week that it would add stronger warning labels to Yaz, Yasmin and other birth control pills containing drospirenone (a synthetic version of the hormone progesterone) about the associated risk of blood clots. But, the FDA emphasized, the risk is still small; smaller, in fact, than the risk of blood clots during pregnancy or the postpartum period, and small enough that women taking the pill shouldn’t worry and should “continue taking their pills as directed unless told otherwise by their healthcare professional.” But headlines like “FDA’s Yasmin and Yaz Blood Clots Warning is a Victory for Consumers” and “The Birth Control Warning You Need To Know About” would make you believe otherwise. So we spoke to Planned Parenthood‘s Vice President of External Medical Affairs, Vanessa Cullins, to find out what we really need to know.

Check out our Q&A with Cullins, who put the risk of popular brands like Yaz, Yasmin, Beyaz, Safyral into perspective for us:

First, can you explain which kinds of birth control are most worrisome?

I want to start out by saying that none of the FDA-approved birth control methods should be considered worrisome. There are risks and benefits to all medications, including prescription birth control. When you look across the board at hormonal-containing birth control pills, whether you’re talking about those that contain drospirenone (like Beyaz, Yasmin or Yaz), or, say, desogestril (like Desogen), all are extremely safe and effective. There are some progestins that carry with them a slightly higher risk of venous thromboembolism—yet venous thromboembulism is still extremely rare and occurs much less often than during pregnancy, childbirth and the postpartum period.

Are there women in particular who are at higher risk?

First of all, if a woman has a history of venous thromoembulism she should not be using hormonal birth control pills that contain estrogen.

But a woman may sit down with her doctor, look at her family history and risk factors in general—for instance perhaps she does a whole lot of plane travel, or has other reasons to be very sedentary, and has never been on a contraceptive formulation in the past—and decide that they want to try a formulation that has a history of a lower risk of venous thromboembulism, such as levonorgestrel. But by the same token, you could have a woman who is on a plane or sedentary a lot, and has been on levonorgestrel formulations in the past and not had a good side effect experience, so she’s willing to accept that increased risk of venal stromboembulism because it’s much more important for her to prevent pregnancy at this point in her life, and she wants to use a pill.

What I’m trying to convey here is that it’s very situational and unique to the circumstances and lifestyle issues of an individual woman. It means taking into account the woman’s individual characteristics as it relates to her medical and family history, and such things as whether or not she’s at an increased risk of venous thromboembulism.

The FDA has said that women should “continue taking their pills as directed unless told otherwise by their healthcare professional.” So why are they requiring the new warning labels?

Because information is a good thing., as long as it is appropriately considered. And by appropriately considered I mean not being alarmed. The information is important in individualizing or tailoring a decision around contraception formulation.

Should women book appointments with their physicians in order to discuss the risks, or just sit back and wait until their next appointment as they normally would?

I would advise women to sit back and wait for their next apointment to discuss this. However if she is extremely worried by all means make a phone call. I think a phone call should be adequate in terms of allowing the physician or health care practitioner to talk about her concerns. If by chance an appointment is needed that can be determined through the phone call.

Is this sort of news damaging for birth control types or brands? Have health warnings on other birth control methods persuaded women to switch?

Unfortunately the reaction generally is one of alarm and both providers and women potentially overreacting and stopping their birth control and this resulting in unintended pregnancy rates going up. This issue is not a new issue: The first time this came about was in 1995 when epidemiological studies in Europe, particularly in Great Britain, showed that pill formulations containing gestodene (which is only available in Europe). And on the basis of the findings being reported in an inappropriate context, you had both providers and women becoming very alarmed and people stopping their preferred birth control formulations and the resulting situation the following year was actually an increase in the abortion rate.

Is there one particular kind of birth control that’s clearly “the safest” or risk free? Is there any sort of dream birth control in that sense?

It depends on what kind of risks you’re looking at. What immediately comes to mind is that when you’re not using anything, then you don’t have any risk associated with mediation or use of that particular thing. So with abstinence you tend to not have medical risks. But you can potentially have some psychological risks…[ed. note: at this point, Cullins and I giggle together over the 'risks' of abstenence] depending on who you are.

I would say that, you know, there are risks associated with anything and everything. Clearly all medications have risk associated with them, and you just have to determine what you’re willing to kind of put up with. Whether you’re talking about side effects or very rare risk.

What do you want to drive home?

I just want to say that decision-making around contraception and women to become pregnant or women to parent is based on risk versus benefits, and what’s important to you and for your family at that particular time in your life. So that risk and benefit balance will change over time. And that’s normal. It’s all about putting things into perspective.

I fyou or a love one has experienced complications form yaz call our new Yaz division today. We will offer you the same TLC as our  lady victims of the horrors of  the vaginal mesh. Ladies we must fight for justice. There are just too many drugs and medical devices harming women.

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Yaz Payoff, Good News For Vaginal Mesh Victims

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

Ladies, Bayer Pharmaceuticals has annonced a settlement for blood clots form yaz victims. The first round is settling for over $200,000 per claimant. This is good news for all litigations of dangerous drugs and medical devices harming women. Vaginal Mesh helpline has expanded resurces to help women injured by other Drugs and Medical devices. With so many drugs and medical devices harming women we see a need for additional helplines.

The Yaz Helpline sponsored by Vaginal Mesh Helpline and Yaz Lawyers are pleased to announce  Bayer, has agreed to pay out at least $110 million to settle 500 lawsuits involving Yaz blood clots. News of the settlements comes at a time when the Yaz lawsuit total exceeds 11,000, with plaintiffs claiming the birth control pill resulted in dangerous Yaz blood clots. The FDA has increased the details of warnings on Yaz labeling to include increased risk of strokes. ladies theis is a good thing and means the Vaginal mesh victims can expect justice when theor turn comes around. Victims of Yaz, It is not too late for you. If you have not filed a claim contact us immediately. Yaz was given out in many states by palnned parenthood to young women for birth control.

Call our new Yaz Yasmin Helpline Speak to a female Social Worker and be connected to a yaz lawyer

Yaz Payoff Complications, Bayer is paying on,

  • blood clot,
  •  stroke,
  •  heart attack,
  •  deep vein thrombosis dvt,
  •  pulmonary embolism,
  •  death,

Safety Announcement
[09-26-2011] The U.S. Food and Drug Administration (FDA) is informing the public that it has not yet reached a conclusion, but remains concerned, about the potential increased risk of blood clots with the use of drospirenone-containing birth control pills. FDA has completed its review of the two 2011 studies that evaluated the risk of blood clots for women who use drospirenone-containing birth control pills, previously mentioned in FDA's Drug Safety Communication issued on May 31, 2011. FDA is continuing its review of a separate FDA-funded study that evaluated the risk of blood clots in users of several different hormonal birth control products (contraceptives). Preliminary results of the FDA-funded study suggest an approximately 1.5-fold increase in the risk of blood clots for women who use drospirenone-containing birth control pills compared to users of other hormonal contraceptives.
Given the conflicting nature of the findings from six published studies evaluating this risk, as well as the preliminary data from the FDA-funded study (See Data Summary), FDA has scheduled a joint meeting of the Reproductive Health Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee on December 8, 2011 to discuss the risks and benefits and specifically the risk of blood clots of drospirenone-containing birth control pills.

Patients should talk to their healthcare professional about their risk for blood clots before deciding which birth control pill to use. Known risk factors that increase the risk of a blood clot include smoking, being overweight (obesity), and family history of blood clots, in addition to other factors that contraindicate use of birth control pills.
Women currently taking a drospirenone-containing birth control pill should be informed of the potential risk for blood clots. FDA previously communicated preliminary information about these concerns to the public on May 31, 2011 .
FDA has prepared a list of questions and answers to provide an overview of this potential safety issue. FDA will continue to communicate any new information to the public as it becomes available
Health Canada is currently reviewing the safety of Bayer Pharmaceutical’s birth control pills, Yaz and Yasmin, in an effort to determine if women who use these drugs are at an increased risk of developing life-threatening blood clots over women using different brands of birth control.

Yaz Lawyers of Free Legal Shield are pleased to  announce that contraceptive Manufacturer, Bayer, has agreed to pay out at least $110 million to settle 500 lawsuits involving Yaz blood clots. News of the settlements comes at a time when the Yaz lawsuit total exceeds 11,000, with plaintiffs claiming the birth control pill resulted in dangerous blood clots.

New Warning Labels on Yaz April 2012

In an announcement released April 10, 2012, the FDA stated that new warnings about the risk of blood clots will now be required on the labels of birth control pills that contain the progestin “drospirenone.” Yaz, Yasmin, Beyaz, and Safyral will now carry warnings detailing recent studies that suggest these pills may carry a slightly higher risk of Yaz blood clots.

Many Studies show Yaz linked to Blood Clots

two new 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. The studies reported that the risk of developing blood clots for women taking the drospirenone-containing pills may be two to three times greater than those who take other pills. Yaz is one of these drugs.

Yaz New Warnings  April 2012

In an announcement released April 10, 2012, the FDA stated that new warnings about the risk of blood clots will now be required on the labels of birth control pills that contain the progestin “drospirenone.” Yaz, Yasmin, Beyaz, and Safyral will now carry warnings detailing recent studies that suggest these pills may carry a slightly higher risk of Yaz blood clots

Yaz side effects include:
• Deep vein thrombosis (DVT)
• Pulmonary embolism (PE)
• Blood clots
• Stroke
• Heart attack
• Gallbladder problems
• Pancreatitis
List of Drugs
Approved Oral Contraceptives containing Drospirenone

    Drospirenone and ethinyl estradiol Drospirenone 3 mg and ethinyl estradiol 0.03 mg
    Ocella Drospirenone 3 mg and ethinyl estradiol 0.03 mg
    Safyral Drospirenone 3 mg, ethinyl estradiol 0.03 mg, and levomefolate calcium 0.451 mg
    Syeda Drospirenone 3 mg and ethinyl estradiol 0.03 mg
    Yasmin Drospirenone 3 mg and ethinyl estradiol 0.03 mg
    Zarah Drospirenone 3 mg and ethinyl estradiol 0.03 mg
    Beyaz Drospirenone 3 mg, ethinyl estradiol 0.02 mg and levomefolate calcium 0.451 mg
    Drospirenone and ethinyl estradiol Drospirenone 3 mg and ethinyl estradiol 0.02 mg
    Gianvi Drospirenone 3 mg and ethinyl estradiol 0.02 mg
    Loryna Drospirenone 3 mg and ethinyl estradiol 0.02 mg
    Yaz Drospirenone 3 mg and ethinyl estradiol 0.02 mg

Recent warnings have linked various birth control drugs and devices to serious injuries and even death:

    Yasmin®
    Yaz®
    Ocella®

Injuries reported:

    Deep Vein Thrombosis
    Pulmonary Embolism
    Stroke
    Heart Attack
    Wrongful Death
    Blood Clot Related Injuries
    Kidney Failure
    Gallbladder Injury/Removal

If you or a loved one has suffered from any of the harmful side effects of Yaz,Yasmin or Ocella such as blood clots, stroke or heart attack you may be entitled to file a Yaz,Yasmin,Ocella lawsuit against the manufacturer. Call us for a yaz lawyer with experience in birth control drug lawsuits toevaluate your claim. Many women around the United States have suffered from life-threatening Yaz,Ocella and Yasmin birth control side effects. The manufacturer can be held liable.
The Woman's Yaz Helpline is here for women suffering from Yasmin and Yaz  and Drospirenone side effects
 

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Yaz Birth Control Pills pay-off, Yaz Lawyers Ready to file

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

Good News  Ladies Perhaps we will see the same with the vaginal mesh lawsuits or even more.

Bayer Said to Pay $110 Million in Yaz Birth-Control Cases

  • Vaginal mesh helpline keeps women informed on all dangerous drugs and medical devices harming women. The $220,000 settlement per case gives hope to our callers suffering from the vaginal mesh. Just like the vaginal mesh women who took  Yaz birth control pills or Yasmin  never imagined that the side effects could harm them as much as they did. But countless women were affected. They suffered many serious injuries that often changed their lives permanently:
  •     Blood clots (deep vein thrombosis or DVT)
  •     Pulmonary embolism
  •     Gallbladder disease
  •     Pancreatitis
  •     Heart attacks
  •     Strokes (both ischemic and hemorrhagic strokes)

Again we say women who have been injured by Yaz must demand justice. If you have had one of the listed complications you must contact our helpline and speak to a Yaz attorney immediately. You still may have a chance. Some states are out of time. Do not wait. If you have been injured by one of the many drugs or medical devices harming women like yaz, Vaginal mesh, Mirena IUD cantact our helpline today.

By Jef Feeley and Margaret Cronin Fisk – Apr 13, 2012 5:48 PM ET

Bayer, Germany’s largest drugmaker, will pay at least $110 million to settle about 500 lawsuits over claims that its Yasmin line of birth-control pills caused blood clots, in the first resolution of cases over the product, people familiar with the agreements said.
Officials of Bayer, based in Leverkusen, Germany, agreed to pay an average of about $220,000 a case to resolve the claims that its Yasmin and Yaz contraceptives caused sometimes fatal clots that can lead to heart attacks and strokes, two people familiar with the settlement said. The people sought anonymity because the accords haven’t been made public.
Bayer fell 2.5 percent in German trading today, and its American depositary receipts dropped 3.8 percent. The settlements came after a federal judge in Illinois postponed a Jan. 9 trial of a suit accusing Bayer and some of its units of misleading women about the health risks of its birth-control pills so a mediator could try to negotiate a settlement.
The case was the first set for trial of more than 11,000 lawsuits over injuries allegedly caused by the drugs.
“Sounds to me like mediation is paying off,” Carl Tobias who teaches product-liability law at the University of Richmond, said in a phone interview. “As a German company, Bayer probably would like to avoid the risks and costs of litigation in U.S. courts. Mediation tends to be a less- expensive way to deal with these kinds of cases.”

Stronger Warnings

The settlements come as the U.S. FDA April 10 ordered Bayer and other contraceptive makers to strengthen the blood-clot warnings on their products.
Pills like Bayer’s Yasmin, which contain a synthetic hormone called drospirenone, will have warning labels saying researchers have found they may triple the risk for clots.
Bayer’s contraceptives generated $1.58 billion in sales in 2010, making them the drugmaker’s biggest-selling drugs after Betarson a multiple sclerosis medication. The Yasmin drugs have been the focus of regulators who question their safety.
“Bayer HealthCare confirms that some cases pending in the current YAZ/Yasmin litigation in the U.S. are being settled,” RY a U.S. spokeswoman for the drugmaker, said in an e-mailed statement. She declined to comment on the number of cases settled or the amount of the accords.
Bayer’s American depository receipts, each worth one ordinary share, fell $2.60, or 3.8 percent, to $65.83 in over- the counter trading today. Shares in Germany dropped 1.28 euros, or 2.5 percent, to 50.56 euros.

Prior Settlements

Bayer officials said in a Feb. 28 U.S. Securities and Exchange Commission filing that the drugmaker has settled 70 cases over the Yasmin line of contraceptives.
Those settlements included “terms and conditions which Bayer views to be reasonable,” officials said in the filing. “Bayer will continue to consider the option of settling individual lawsuits in the U.S. on a case-by-case basis.”
The company is expecting additional suits, officials said in the SEC filing Last year, the U.S. FDAwarned that women taking the pills were 74 percent more likely to suffer blood clots than women on other low-estrogen contraceptives.
The FDA examined data on more than 835,000 women who took pills containing Drospirenone including Bayer’s Yasmin line of birth-control pills, according to the FDA report.
Bayer’s Yasmin was the No. 4 oral contraceptive in the U.S. in 2011, with 4.6 percent of the market as of September, according to data from IMS Health.

Wave of Litigation

Since 2009, the German drugmaker has faced a wave of lawsuits in courts across the U.S. alleging the birth-control pills caused sometimes fatal blood clots. Lawyers suing the drugmaker cited FDA reports of at least 50 deaths tied to the pills from 2004 to 2008.
Lawyers for former Yaz users contend in court filings that Bayer officials sought to market the contraceptive fgor unapproved uses and misled women about the drug’s health risks
The cases filed in federal courts were consolidated before U.S. District Judge David Herndon in St Louis for pretrial proceedings.

Scheduled Trials

Herndon scheduled a series of trials for early this year so juries could begin weighing claims that Bayer and its units marketed Yaz and other contraceptives as safer than rivals’ products while knowing they posed a higher clot risk.
At Bayer’s suggestion, Herndon called in Stephen Saltzburg, a George Washington University law professor, to serve as a mediator. Saltzburg’s job was to explore the possibility of “settlements in this litigation,” Herndon said in a December 2011 order. The judge put the trial schedule on hold while Saltzburg met with lawyers for the drugmakers and former Yaz users.
Among the lawyers settling Yaz cases as a result of Saltzburg’s efforts are Mark Robinson Chris Seeger and Michael Berg the people familiar with the accords said.
Those three lawyers are serving on the so-called plaintiffs steering committee in the cases before Herndon, according to court filings That group helps decide how the consolidated cases should progress through the litigation process.
Burg, a Denver-based plaintiffs’ lawyer who handles product-liability cases, also is listed in court filings as co- lead plaintiffs’ counsel in the Yaz cases. He declined to comment on the settlements in a interview today.
Seeger, based in New York, and Robinson, a Los Angeles- based attorney, didn’t immediately return calls seeking comment on the settlement.
The case is In re Yasmin and Yaz (Drospirenone) Marketing, Sales Practices and Product Liability Litigation, 09-md-02100, U.S. District Court, Southern District of Illinois (East St. Louis).
Call the Yaz Women's helpline today

 

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Has A Lawyer rejected Your Vaginal Mesh Case ? Get a Second Opinion

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

At the Vaginal Mesh Helpline we have been contacted by many women whose vaginal mesh case has been rejected by a law firm for many different reasons. Many are inexperienced local lawyers while  others have been rejected for a variety of other reasons. The key factors appear to be lack of confirmation from a physician that the mesh is casuing a problem and that either revision surgery or removeal is needed. Well ladies ,you know when you have symptoms. However, many doctors are not willing to say that the mesh is causing a problem or women do not have funds to go to a doctor. Call the vaginal mesh helpline to be connected to a law fim  and get a second opinion. Do not give up hope . You must seek justice.

FDA Adverse reporting Guidelines
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:

Documenting this type of information will be extremely helpful when you contact a lawyer as well. The FDA guidlines are an excellent record keeping formate to follow.

  •     Manufacturer's name
  •     Product name (brand name)
  •     Catalog number
  •     Lot number
  •     Size
  •                               Your Lawyer Will Want to Know
  •     Date of implant
  •     Date of explant (if mesh was removed)  (Important)
  •     Details of the adverse event and medical and/or surgical interventions ( Important )
  •  
  •     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

Vaginal mesh failure symptoms

Complications of the Vaginal Mesh include:

  • Failure of the Procedure
  • Pain (Vagina, leg, pelvic, adbominal)
  • rejection of the graft material
  • chronic continuous relentless infections
  • the need for constant antibiotics
  • patch bleeding
  • lower back pain
  • pain on one side of the body
  • painful sexual intercourse
  • partner feeling the mesh
  • constant bleeding or spotting
  • Recurrent urinary tract infection
  • Extrusion of the mesh into the vagina causing pain, discharge, bleeding
  • Erosion of the mesh into bowel, bladder, urethra, or rectum

For medical Support

Contact a local University Hospital Dept of Urogynecology

or the American Association of Urogynecology

or see the states and resource pages on vaginalmeshhelpline.com

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