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Posts Tagged ‘vaginal mesh helpline’

Vaginal Mesh Lawsuits Trials Update, Vaginal Mesh Lawyers

Written by lisaspitzer on . Posted in Alabama Multidistrict Litigation Lawyers, Arizona Multidistrict Litigation Lawyers, Arkansas Multidistrict Litigation Lawyers, California Multidistrict Litigation Lawyers, Colorado Multidistrict Litigation Lawyers, Connecticut Multidistrict Litigation Lawyers, Delaware Multidistrict Litigation Lawyers, Florida Multidistrict Litigation Lawyers, Georgia Multidistrict Litigation Lawyers, Hawaii Multidistrict Litigation Lawyers, Idaho Multidistrict Litigation Lawyers, Illinois Multidistrict Litigation Lawyers, Indiana Multidistrict Litigation Lawyers, Iowa Multidistrict Litigation Lawyers, Kansas Multidistrict Litigation Lawyers, Maine Multidistrict Litigation Lawyers, Maryland Multidistrict Litigation Lawyers, Massachusetts Multidistrict Litigation Lawyers, Medical Device Lawsuits, Michigan Multidistrict Litigation Lawyers, Minnesota Multidistrict Litigation Lawyers, Mississippi Multidistrict Litigation Lawyers, Missouri Multidistrict Litigation Lawyers, Montana Multidistrict Litigation Lawyers, Multidistrict Lawsuit News, Nebraska Multidistrict Litigation Lawyers, Nevada Multidistrict Litigation Lawyers, New Hampshire Multidistrict Litigation Lawyers, New Jersey Multidistrict Litigation Lawyers, New Mexico Multidistrict Litigation Lawyers, New York Multidistrict Litigation Lawyers, North Carolina Multidistrict Litigation Lawyers, North Dakota Multidistrict Litigation Lawyers, Ohio Multidistrict Litigation Lawyers, Oklahoma Multidistrict Litigation Lawyers, Oregon Multidistrict Litigation Lawyers, Pennsylvania Multidistrict Litigation Lawyers, Rhode Island Multidistrict Litigation Lawyers, South Carolina Multidistrict Litigation Lawyers, South Dakota Multidistrict Litigation Lawyers, Texas Multidistrict Litigation Lawyers, Utah Multidistrict Litigation Lawyers, Vermont Multidistrict Litigation Lawyers, Virginia Multidistrict Litigation Lawyers, Washington DC Multidistrict Litigation Lawyers, Washington Multidistrict Litigation Lawyers, West Virginia Multidistrict Litigation Lawyers, Wisconsin Multidistrict Litigation Lawyers, Wyoming Multidistrict Litigation Lawyers

The trials for the vaginal mesh lawsuits are going to begin in 2013. Thousands of women have been severely injured by the vaginal mesh devices.

Vaginal Mesh Lawsuit Update: Federal Judge Issues New Rulings In Pelvic Mesh MDLs
PR Web

New York, NY (PRWEB) August 27, 2012
Vaginal mesh lawsuits included in four related pelvic mesh multidistrict litigations are subject to newly issued discovery orders, Bernstein Liebhard LLP reports. On August 22 and August 23, 2012, the Honorable Joseph R. Goodwin, who is overseeing the pelvic mesh multidistrict litigations currently pending in the U.S. District Court for the Southern District of West Virginia, issued four pretrial orders in the following actions: In re: American Medical Systems, Inc., Pelvic Repair Systems Products Liability Litigation (“MDL No. 2325”); In re: Boston Scientific Corp., Pelvic Repair Systems Products Liability Litigation (“MDL No. 2326”); In re: Ethicon, Inc., Pelvic Repair System Products Liability Litigation (“MDL No. 2327”); and In re: C.R. Bard, Inc., Pelvic Repair System Products Liability Litigation (“MDL No. 2187”).* The first three pretrial orders deal with the filing of complaints in the American Medical Systems, Boston Scientific Corp., and Ethicon MDLs. The fourth pretrial order sets forth deadlines for bellwether trial selection and related discovery in the C.R. Bard MDL.

Orders Standardize Complaint Forms For Plaintiffs To File Vaginal Mesh Lawsuits
The first three orders allow each plaintiff to utilize and complete a standardized complaint form in order to file a lawsuit against American Medical Systems, Boston Scientific Corp, and Ethicon, respectively. The standardized complaint promotes efficiency and expedites the litigation process. The form complaint allows plaintiffs to make claims against the pelvic mesh manufacturers for multiple causes of action, including: negligence, strict products liability, and breach of warranty. Additionally, the form complaints permit plaintiffs to seek damages, including: personal injury, wrongful death, economic loss, loss of services, and loss of consortium. Similarly, defendants must file a master answer in response to each complaint.  

Discovery Scheduling Order Issued In C.R. Bard MDL

Judge Goodwin also issued a pretrial order that will govern the course of the multidistrict litigation against C.R. Bard for the second group of lawsuits pending against the manufacturer. Previously, Judge Goodwin set a trial date of February 5, 2013 for the first federal vaginal mesh lawsuit against C.R. Bard. According to this latest order, trials for the second group of lawsuits against C.R. Bard will begin on June 24, 2013.

Coloplast Vaginal Mesh Lawyers, Coloplast Vaginal Mesh Lawsuits

Written by lisaspitzer on . Posted in Alabama Multidistrict Litigation Lawyers, Arkansas Multidistrict Litigation Lawyers, California Multidistrict Litigation Lawyers, Class MDL Class Action News, Colorado Multidistrict Litigation Lawyers, Connecticut Multidistrict Litigation Lawyers, Delaware Multidistrict Litigation Lawyers, Florida Multidistrict Litigation Lawyers, Idaho Multidistrict Litigation Lawyers, Illinois Multidistrict Litigation Lawyers, Indiana Multidistrict Litigation Lawyers, Iowa Multidistrict Litigation Lawyers, Maryland Multidistrict Litigation Lawyers, Massachusetts Multidistrict Litigation Lawyers, Michigan Multidistrict Litigation Lawyers, Missouri Multidistrict Litigation Lawyers, Montana Multidistrict Litigation Lawyers, Nebraska Multidistrict Litigation Lawyers, Nevada Multidistrict Litigation Lawyers, New Hampshire Multidistrict Litigation Lawyers, New York Multidistrict Litigation Lawyers, North Carolina Multidistrict Litigation Lawyers, North Dakota Multidistrict Litigation Lawyers, Ohio Multidistrict Litigation Lawyers, Oklahoma Multidistrict Litigation Lawyers, Oregon Multidistrict Litigation Lawyers, Pennsylvania Multidistrict Litigation Lawyers, South Carolina Multidistrict Litigation Lawyers, Texas Multidistrict Litigation Lawyers, Utah Multidistrict Litigation Lawyers, Virginia Multidistrict Litigation Lawyers, Washington DC Multidistrict Litigation Lawyers

As the lawsuits keep mounting up a new vaginal mesh manufacturer has been added. It seems as if there is no end to companies that have jumped on the golden mesh band wagon. Over 300,000 women have been implanted with vaginal mesh devices. Despite the warnings, and T.V lawyer ads,  doctors are still putting mesh in to this date. It never ceases to amaze me to see doctors sugggesting a brand new mesh over the old failed one. The vaginal mesh MDL lawyers are now filing lawsuits for a new mesh manufacturer that has been added to the West Virginia MDL, Coloplast. See the vaginal mesh news update below:

 Coloplast Vaginal Mesh  Products  Have Been Named in Mesh Lawsuits
According to their website, Coloplast develops products and services “to make life easier for people with deeply personal and private medical conditions.” The company has a special focus on surgical urology, developing surgical devices for both men and women. For women, Coloplast markets products to treat pelvic organ prolapse and to control urinary incontinence.
The August 6 order by the JPML centralized 13 Coloplast pelvic mesh lawsuits into West Virginia. All plaintiffs allege that the company’s products caused serious injuries. The products at issue in these lawsuits, Novasilk, Exair, Suspend, and Axis, are used to treat pelvic organ prolapse by supporting weakened pelvic muscles.
Consolidation into one court helps conserve resources, increase efficiency, and reduce the risk of duplicative discovery or conflicting rulings from other courts. Each lawsuit retains its individual nature, however, and will be returned to its original court for trial after pre-trial proceedings are complete.

This is part of the huge multi district litigations being filed by vaginal mesh lawyers for 1000's of women nationwide.

Vaginal Mesh Helpline, Vaginal Mesh Lawsuit Lawyers

Written by lisaspitzer on . Posted in Alabama Multidistrict Litigation Lawyers, Alaska Multidistrict Litigation Lawyers, Arizona Multidistrict Litigation Lawyers, Arkansas Multidistrict Litigation Lawyers, California Multidistrict Litigation Lawyers, Colorado Multidistrict Litigation Lawyers, Connecticut Multidistrict Litigation Lawyers, Delaware Multidistrict Litigation Lawyers, Florida Multidistrict Litigation Lawyers, Georgia Multidistrict Litigation Lawyers, Hawaii Multidistrict Litigation Lawyers, Idaho Multidistrict Litigation Lawyers, Illinois Multidistrict Litigation Lawyers, Indiana Multidistrict Litigation Lawyers, Iowa Multidistrict Litigation Lawyers, Kansas Multidistrict Litigation Lawyers, Maine Multidistrict Litigation Lawyers, Maryland Multidistrict Litigation Lawyers, Massachusetts Multidistrict Litigation Lawyers, Michigan Multidistrict Litigation Lawyers, Minnesota Multidistrict Litigation Lawyers, Mississippi Multidistrict Litigation Lawyers, Missouri Multidistrict Litigation Lawyers, Montana Multidistrict Litigation Lawyers, Nebraska Multidistrict Litigation Lawyers, Nevada Multidistrict Litigation Lawyers, New Hampshire Multidistrict Litigation Lawyers, New Jersey Multidistrict Litigation Lawyers, New Mexico Multidistrict Litigation Lawyers, New York Multidistrict Litigation Lawyers, North Carolina Multidistrict Litigation Lawyers, North Dakota Multidistrict Litigation Lawyers, Ohio Multidistrict Litigation Lawyers, Oklahoma Multidistrict Litigation Lawyers, Oregon Multidistrict Litigation Lawyers, Pennsylvania Multidistrict Litigation Lawyers, Rhode Island Multidistrict Litigation Lawyers, South Carolina Multidistrict Litigation Lawyers, South Dakota Multidistrict Litigation Lawyers, Tennessee Multidistrict Litigation Lawyers, Texas Multidistrict Litigation Lawyers, Utah Multidistrict Litigation Lawyers, Vermont Multidistrict Litigation Lawyers, Virginia Multidistrict Litigation Lawyers, Washington DC Multidistrict Litigation Lawyers, Washington Multidistrict Litigation Lawyers, West Virginia Multidistrict Litigation Lawyers, Wisconsin Multidistrict Litigation Lawyers, Wyoming Multidistrict Litigation Lawyers

The Vaginal Mesh Helpline 1 877 522-2123 has launched a nationwide campaign to help women with a vaginal mesh locate doctors for mesh removal and vaginal mesh lawsuit lawyers. The Vaginal Mesh Helpline is also offering lawyers an opportunity for referral to lead lawyers and help with a medical doctor. Many lawyers call the helpline for basic information about the mesh and it's relationship to various female related medical conditions. The Vaginal Mesh Helpline gets calls from lawyers nationwide with questions regarding the mesh lawsuits. Our multi  district litigation lawyers are filing vaginal mesh lawsuits.

The Vaginal  Mesh Helpline is a Resource  For Women With Complications From Mesh Implants
The Vaginal Mesh Helpline and support group is here  for women who are victims of malfunctioning Prolapse, Surgical Mesh for uterine Prolapse.

(PRWEB) September 24, 2011

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

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

The various vaginal mesh products have been in the news the past few weeks due to the current FDA meetings with clinicians and manufacturers.

Because of the many Horror Stories,  the Vaginal Mesh Helpline  has an online support group for women to share their stories and get support from other women. According to Lisa Spitzer MSW,, "The vaginal surgical mesh complications have taken their toll on women not just physically but, psychologically." Spitzer says, "These side effects have added stress to marriages and changed the quality of life of women effected. I have listened to so many horror stories. Women need a support group to share their feelings and experiences. They should not be left to feel helpless and alone. The approval the FDA gave these companies was inadequate. These women have suffered severely."

One woman who called today said, "This is effecting entire families. When mommy does not feel good the entire family suffers."

Spitzer continues, "women call in tears, lives completely turned around. They are in constant pain. Many have lost faith in their doctors and do not know where to turn or what doctor to trust. Men are being effected as well when the mesh erodes thru the vaginal wall. The stories are endless. The pain, suffering and tears is a daily occurrence on the helpline."

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

The Vaginal Mesh Helpline Vaginal Mesh Lawyer Network is not just lawyers interested in cases. They offer support and help to women going thru this traumatic experience. The helpline is not only a means of connecting with an experienced physician, but also support and information. Women are encouraged to leave their stories on line for other women to read and know they are not alone. According to Spitzer, spokes person for Injury Lawyer Network, "women should see a physician immediately to know where they stand and make available all avenues for financial compensation." Spitzer continues, "For the stories I hear ,there is no compensation large enough that will justify this kind of pain and suffering."

the Vaginal Mesh legal team is accepting claims against the various manufacturers for the women who are victims. Spitzer says, "the FDA must hear these suffering voices and act." The helpline suggests the every woman file an adverse indident report with the FDA.

Call the Vaginal Mesh Helpline 1 877 522-2123

Bard Vaginal Mesh Lawsuit Trials to Begin, Bard Vaginal Mesh lawyers

Written by lisaspitzer on . Posted in Arizona Multidistrict Litigation Lawyers, California Multidistrict Litigation Lawyers, Connecticut Multidistrict Litigation Lawyers, Delaware Multidistrict Litigation Lawyers, Florida Multidistrict Litigation Lawyers, Georgia Multidistrict Litigation Lawyers, Idaho Multidistrict Litigation Lawyers, Illinois Multidistrict Litigation Lawyers, Indiana Multidistrict Litigation Lawyers, Kansas Multidistrict Litigation Lawyers, Maine Multidistrict Litigation Lawyers, Maryland Multidistrict Litigation Lawyers, Massachusetts Multidistrict Litigation Lawyers, Medical Device Lawsuits, Michigan Multidistrict Litigation Lawyers, Minnesota Multidistrict Litigation Lawyers, Mississippi Multidistrict Litigation Lawyers, Missouri Multidistrict Litigation Lawyers, Montana Multidistrict Litigation Lawyers, Nebraska Multidistrict Litigation Lawyers, Nevada Multidistrict Litigation Lawyers, New Hampshire Multidistrict Litigation Lawyers, New York Multidistrict Litigation Lawyers, North Carolina Multidistrict Litigation Lawyers, North Dakota Multidistrict Litigation Lawyers, Ohio Multidistrict Litigation Lawyers, Oklahoma Multidistrict Litigation Lawyers, Oregon Multidistrict Litigation Lawyers, Pennsylvania Multidistrict Litigation Lawyers, Rhode Island Multidistrict Litigation Lawyers, South Carolina Multidistrict Litigation Lawyers, South Dakota Multidistrict Litigation Lawyers, Texas Multidistrict Litigation Lawyers, Transvaginal mesh, Utah Multidistrict Litigation Lawyers, Virginia Multidistrict Litigation Lawyers, Washington DC Multidistrict Litigation Lawyers, Washington Multidistrict Litigation Lawyers, West Virginia Multidistrict Litigation Lawyers, Wisconsin Multidistrict Litigation Lawyers, Wyoming Multidistrict Litigation Lawyers

C.R Bard is one of the manufacturers of the Prolene vaginal mesh products and is the focus of vaginal mesh lawsuits by transvaginal mesh lawsuit lawyers. 1000's of women have been injured by vaginal mesh implants manufactured by a number of corporations including C.R Bard. Multi district litigation lawyers of the vaginal mesh department are filing 100's of lawsuits for mesh complications.

Bard Faces First Federal Trial Over Vaginal Mesh Next Year
By Jef Feeley and David Voreacos – May 2, 2012 5:05 PM ET

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, at jfeeley@bloomberg.net; David Voreacos in Newark, New Jersey, at dvoreacos@bloomberg.net

TransVaginal Mesh Lawsuit, Transvaginal Mesh Lawyers

Written by lisaspitzer on . Posted in California Multidistrict Litigation Lawyers, Class MDL Class Action News, Colorado Multidistrict Litigation Lawyers, Connecticut Multidistrict Litigation Lawyers, Florida Multidistrict Litigation Lawyers, Georgia Multidistrict Litigation Lawyers, Illinois Multidistrict Litigation Lawyers, Indiana Multidistrict Litigation Lawyers, Kansas Multidistrict Litigation Lawyers, Maryland Multidistrict Litigation Lawyers, Massachusetts Multidistrict Litigation Lawyers, Michigan Multidistrict Litigation Lawyers, Nebraska Multidistrict Litigation Lawyers, New Jersey Multidistrict Litigation Lawyers, New Mexico Multidistrict Litigation Lawyers, New York Multidistrict Litigation Lawyers, North Carolina Multidistrict Litigation Lawyers, Oregon Multidistrict Litigation Lawyers, Pennsylvania Multidistrict Litigation Lawyers, Virginia Multidistrict Litigation Lawyers, West Virginia Multidistrict Litigation Lawyers

 A Transvaginal mesh  is a surgical implant which is used to treat POP ( pelvic organ prolapse ) and stress urinary incontinence (SUI) in women.   These medical problems are a result of a weakened pelvic floor  due to age, childbirth, hysterectomy, or menopause.
Because of the agressive  sales job done by these medical device manufactures, vaginal mesh repair became very common and now over 300,000 women have a mesh implant.

The doctor used a surgical mesh to help reinforce the vaginal wall and to provide an additional supporting mesh structure  to organs like the bladder, bowel or uterus  However, it became apparent after several years after this product was used, many women began to experience complications like pain, infection, bleeding, mesh erosion. lower back pain, increased bowel and urinary problems and the inability to have sexual intercourse due to the severe pain. Many complications have resulted form these mesh implants and they all appear to be similiar no matter waht mesh product has been implanted thru the vaginaa:
    •    Mesh erosion through vaginal wall, bladder or bowel
    •    Infection that does not go away
         Organ perforation
    •    Pain like a knife
    •    Urinary incontinence is back
    •    Recurrence of prolapse
    •    Bladder, bowel or vessel perforation
    •    Vaginal scarring
    •    Pain during sexual intercourse
    •    Other problems that led to a significant decrease in patient quality of life due 
to discomfort and pain.
Now, after receiving over 3000 complaints from women who suffered serious injuries caused by polypropylene transvaginal device/mesh, the FDA issued a very detailed and comprehensive statement to warn doctors that they should consider no longer using mesh to treat their patients.  Just recently Johnson and Johnson removed 4 Gynecare products form the market and did a label change on the fitth. 

If you or a loved one is suffering due to a vaginal mesh implant call us now. We will file a vaginal mesh lawsuit for you and help you locate a doctor.

Women Sueing For Vaginal Mesh Malfunction

Written by lisaspitzer on . Posted in Medical Device Lawsuits, Transvaginal mesh

Thousands of women nationwide are sueing the manufacturers of various vaginal mesh and bladder sling implants for the complications that have destroyed their lives and marriages.

The vaginal mesh is a Prolene sling device used for bladder, bowel or Uterine prolapse and incontinence. However is has had vary severe complications including: erosion into the vaginal canal, bladder and bowel, organ perforation, infections that never go away, bleeding,lower back pain and the inability to have sexual intercourse.

Manufacturers:

Transvaginal Mesh, Vaginal Mesh and Bladder Sling  Manufacturers

Bard, Gynecare, ( a J & J Ethicon product ), AMS (American Medical Systems) and Boston Scientific  have the largest market shares of transvaginal mesh products.

C.R. Bard's products include:

        Bard Pelvitex
        Bard Pelvisoft
        Bard Pelvilace or Pelvicol
        Bard Utrtex
        Bard Uretex TO
        Bard Uretex TOO2
        Bard Uretex TOO3

Gynecare/Ethicon/Johnson & Johnson products include:

        Gynecare Prosima
        Gynecare TVT Exact
        Gynecare TVT Abbrevo
        Gynecare TVT Retropubic System
        Gynecare TVT
        Gynecare TVT Obturator
        Gynecare TVT Secur
        Gynecare Gynemesh PS
        Gynecare Prolift
        Gynecare Prolift+M

AMS's products include:

        AMS MiniArc Precise Single-Incision Sling
        AMS MiniArc Single Incision Sling
        AMS Monarc Subfascial Hammock
        AMS In-Fast Ultra Transvaginal Sling
        AMS BioArc
        AMS Sparc Self-Fixating Sling System
        AMS Elevate
        AMS Perigree
        AMS Apogee

Boston Scientific products include:

        Boston Scientific Arise
        Boston Scientific Pinnacle
        Boston Scientific Advantage Fit
        Boston Scientific Lynx
        Boston Scientific Obtryx
        Boston Scientific Prefyx PPS
        Boston Scientific Solyx

Tyco Covidian (which manufacturers the Tyco Covidian Duo and Mentor ObTape)

The mesh litgations are not class actions but, multi -district litigations. They are consolidated in certain courtrooms in the country. For an experienced multi district litigation lawyer handing the mesh call our network today.

 

J & J Sold Vaginal Mesh Without Approval, Vaginal Mesh Lawyers filing Vaginal Mesh Lawsuits For Injured Women

Written by lisaspitzer on . Posted in Medical Device Lawsuits, Transvaginal mesh

Vaginal Mesh Multi District Litigation lawsuits are being filed by the Vaginal mesh Multi District  litigation division of Class Action Lawyer Network. It appear Johnson and Johnson was selling the vaginal mesh product on it's own initiative.

J&J Sold Vaginal Mesh Implant After Sales Halt Ordered
By DVoreacos and A Nussbaum – Jun 26, 2012 2:23 PM ET

Johnson & Johnson (JNJ), the biggest health-care products maker, continued to sell a vaginal mesh implant for nine months after U.S. regulators told the company to stop marketing the device, according to court records.

The U.S. Food and Drug Administration told J&J in a letter on Aug. 24, 2007, to halt Gynecare Prolift sales until the agency decided whether the device was “substantially equivalent” to other products on the market. The FDA cited the “potential high risk for organ perforation” when surgeons insert the mesh vaginally to support weakened pelvic tissue.
Enlarge image J&J Sold Vaginal Mesh Implant After FDA Ordered Sales Halted

On June 5, J&J said it will stop selling four vaginal mesh implants including the Prolift. Photographer: Daniel Acker/Bloomberg

“You may not market this device until you have provided adequate information” on 16 potential deficiencies and received FDA approval, the agency told New Brunswick, New Jersey-based J&J in the letter. “If you market the device without conforming to these requirements, you will be in violation of the Federal Food, Drug and Cosmetic Act.”

The FDA cleared the device in May 2008 without ordering sanctions, after nine months of negotiations with J&J’s Ethicon unit. The company faces more than 1,400 lawsuits by women who said the mesh caused organ perforation, pain, scarring and nerve damage. Lawyers for the women said the device’s approval history could increase J&J’s cost to resolve the litigation.

J&J began selling the Prolift in 2005 without filing a new application after determining on its own that it was substantially similar to the Gynemesh, a company device already approved by the FDA, said Matthew Johnson, a J&J spokesman, in an e-mail. The device maker relied on FDA guidance for when companies must submit new applications, Johnson said.

The FDA disagreed with J&J’s interpretation and required a new application that prompted questions in the August 2007 letter, Morgan Liscinsky, an agency spokeswoman, said in an e- mail.

J&J faced no sanctions because the FDA determined that the company applied the guidance in good faith and it “promptly complied” when the agency required a new application, Liscinsky said.
Fines, Injunctions

Sanctions for selling products without approval may include fines, injunctions against a company or senior managers and the seizure of illegally marketed devices, Liscinsky said.

The August 2007 letter was “only one part of an extended dialogue with FDA in 2007-08, and it is out of context,” Johnson said in the e-mail. “Throughout this process, our actions were responsible, appropriate and consistent with FDA regulations.”

Henry G. Garrard III, a lawyer who represents women suing in federal court in Charleston, said the FDA’s failure to take additional steps to halt Prolift sales or to sanction J&J raises questions about the agency’s power to protect patients.

“Companies know the FDA has little enforcement ability and scarce resources,” Garrard, of Blasingame, Burch, Garrard & Ashley PC in Athens, Georgia, said in a telephone interview.

“Every woman in America who has been implanted with these devices absolutely should be outraged,” he said. “They should be mad at the company because the company knew they could get away with it.”
‘Water Pistol’

The Prolift negotiations point out “the industry’s ability to shrug off FDA enforcement,” said Erik Gordon, a business professor at the University of Michigan, in an e-mail. “If companies can get away with selling products they aren’t supposed to sell, the FDA is a sheriff packing a water pistol.”

The U.S. Senate is to vote today on changes to the FDA’s device-review system, which has drawn scrutiny for allowing implants like vaginal mesh on the market without human testing.

The bill increases funding for reviews and the FDA’s power to order safety studies after a product is cleared. It doesn’t include powers sought by consumer groups to let the FDA require clinical trials for more implants before they reach the market. The House of Representatives approved the measure last week.
Implants Threaded

Surgeons thread mesh implants through vaginal incisions and use the devices to treat incontinence or pelvic organ prolapse, a condition in which weakened muscles fail to support organs. Almost 300,000 were used in U.S. women in 2010, the FDA estimated last year.

An FDA database of reported malfunctions, deaths and serious injuries shows the agency received 123 complaints about the Prolift from 2005 to May 15, 2008, when the device won clearance. The company said in a September 2007 letter to regulators that reported problems accounted for less than 0.5 percent of sales for both Gynemesh and Prolift.

An agency report in July found a fivefold jump in deaths, injuries or malfunctions tied to prolapse mesh inserted vaginally. In January, the FDA ordered J&J, Murray Hill, New Jersey-based C.R. Bard Inc. (BCR) and other manufacturers to study organ damage and complications related to the products.
Sales Estimates

Manufacturers including J&J sold about $175 million worth of prolapse mesh worldwide and another $295 million for incontinence treatments in 2010, C.R. Bard executives estimated on a conference call that year. Even for top sellers of the devices, the products made up no more than 2 percent of company sales, said Michael Matson, a Mizuho Securities USA analyst in New York.

The numbers declined as lawsuits were filed, he said in a telephone interview.

“The doctors aren’t implanting them,” Matson said. “The patients don’t want them.”

On June 5, J&J said it will stop selling four vaginal mesh implants including the Prolift. The move wasn’t a recall and J&J remains confident in the safety and effectiveness of the devices, Johnson said. The company won’t withdraw the Prolift before its “planned discontinuation” of the mesh products over the next three to nine months, he said.

“Our decision to discontinue these products is based on their commercial viability in light of changing market dynamics,” he said.
Label Update

In letters to state and federal judges, the company said that it will update labeling for one device, the Gynemesh, to allow only abdominal, not vaginal, insertion.

The FDA learned of the Prolift after J&J cited it in an application to sell a related device, the Prolift+M, Liscinsky said. The agency told J&J to file for the Prolift as well, and it combined the review for both devices before the August 2007 letter.

“Due to the complexity of this procedure and potential high risk for organ perforation, bench testing is not sufficient to demonstrate device safety and efficacy,” the FDA said in the letter. Bench testing refers to laboratory testing to determine how a device will function in a person.

In the August 2007 letter, the FDA asked 16 questions about the Gynemesh and Prolift, which are made of the same nonabsorbable polymer. The Prolift kit includes pre-shaped mesh and instruments to help surgeons implant the device.
Complications

One FDA query was about a “significant number” of complications from 2004 to 2007 on the earlier device, the Gynemesh. The agency got 174 such reports, including for infection, abscess and organ perforation. Most of the cases required additional surgery.

The agency’s letter also found that labeling for the Prolift+M device was deficient because it couldn’t support claims that the mesh has “elastic properties that allow adaptation to physiological stresses.” In its response, J&J agreed to remove that claim.

Many of the documents unsealed last month include e-mails between J&J and the FDA over the wording of product labeling about the benefits and risks.

Six days before the FDA cleared the Prolift, J&J agreed in a written response to say in the label that the safety and effectiveness of the device, compared to conventional surgical repair without mesh, “have not been demonstrated in randomized controlled clinical trials.”

Rather, J&J wrote, the substantial equivalence to earlier approved devices had been demonstrated through other tests.

The federal cases are In re Ethicon Inc., Pelvic Repair System Products Liability Litigation, 12-md-02327, U.S. District Court, Southern District of West Virginia (Charleston).

If you have a Gynecare Vaginal mesh and are having complications call us today. We are also accepting cases for Yaz, Yasmin, Mirena IUD, NuvaRing and all drugs and devices harming women.

 

Mirena IUD Lawyers, Vaginal Mesh lawsuit Lawyers

Written by lisaspitzer on . Posted in Medical Device Lawsuits

Mirena IUD lawyers are reviewing cases for the Mirena IUD for a perforated uterus only. Vaginal mesh lawyers are filing lawsuits for the severe complications resulting from the Prolene vaginal mesh and bladder sling.

Women throughout the United States who received Mirena IUD for birth control are calling the Mirena IUD Helpline with serious complications. The stories we are hearing include complications of the  implanted device where it has punctured or perforated the uterus. Many of our callers tell us the Mirena IUD has migrated through the intra-abdominal cavity.  Many of the stories we hear are consistent with the following

  •     Perforation of the Uterus or nearby organs
  •     Migration of the device where it becomes embedded in the Uterus or abdominal cavity
  •     Expulsion of the IUD
  •     The need to have the IUD surgically removed and difficulty in finding the IUD

Our Mirena Silicone IUD lawyers are reviewing cases to seek justice for injured women. The lasuits will claim that the manufacturer failed to adequately warn women about the risk of Mirena perforating the Uterus and the additonal complications where the device punctures or embeds in the uterine wall. This can lead to infections, internal scarring and the need for surgery to repair the torn tissues.

In some cases, the Mirena IUD may migrate through the uterine wall, causing serious intestinal problems or other internal injuries, including  serious damage to nearby organs.

The Mirena IUD is manufactured by Bayer pharmaceuticals who has recently settled on Blood Clots from Yaz birth control pills. Mirena is a soft, flexible IUD that releases small amounts of hormone locally into your uterus. According to ther manufacturer  "It gives you birth control you can count on" However that is not taking into account the side effects we have been hearing daily.

Call now to speak to a Mirena IUD lawyer. We are also handling Yaz birth control pills lawsuits and the vaginal mesh litigations.

Mirena IUD and A Perforated Uterus

Written by Class Action Lawyer on . Posted in Class MDL Class Action News

The Mirena IUD along with the vaginal mesh, Yaz, Yasmin are devices and Drugs harming women. Mirena IUD Class Action lawyers are currently reviewing cases for a Mirena IUD Class Action, MDL Lawsuit. If you have a perforated uterus from the Mirena IUD contact us today for a case review.

Birth control drugs and devices  have been the central focus  of lawsuits. Yaz, Yasmin, Beyaz, NuvaRing and the related Vaginal Mesh are just some of the birth control medications, devices and related women problem devices that are causing  injuries, death and destroying lives.
The Mirena IUD is being currently reviewed by our Mirena IUD lawyers. Mirena is manufactured by Bayer ,which also manufacturers Yaz and Beyaz. It is a flexible silicone  intrauterine device that is placed into the uterus through the vagina by a physician. Mirena releases a continuous dose of the hormone levonorgestrel to prevent pregnancy for up to five years.

The first-generation IUD Dalkon Shield was well known for its complications, including :infection, sepsis, miscarriage and even death. Ther Over 300,000 IUD  Dalkon Shield lawsuits were filed.

The problems Mirena IUD  lawyers are accepting  Mirena Silicone  IUD  cases for include puncture of the uterus or the device becoming firmly embedded in the uterus. This can cause bleeding and other serious complications. The device must have moved or gravitated, and can not be located. If you have had the device surgically removed we want to hear from you.

The vaginal mesh lawsuit trials are underway. Lawyers are beginning the depositions of key players. The clock is ticking File you vaginal mesh lawsuit now.