Posts Tagged ‘ American Medical Systems ’

Endo/ American Medical Systems Under Investigation for Transvaginal Mesh

Mar 5th, 2014 | By
Endo/ American Medical Systems Under Investigation for Transvaginal Mesh

Endo Health Solutions took over American Medical Systems (AMS) in 2011 for $2.9 billion and in doing do inherited roughly 22,000 transvaginal mesh lawsuits. That may have been a mistake. In its annual report released by the Securities and Exchange Commission Monday, Endo says it has received subpoenas from several states investigating its pelvic mesh
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Anatomy of a Transvaginal Mesh Litigation Settlement

Feb 27th, 2014 | By
Anatomy of a Transvaginal Mesh Litigation Settlement

On June 14, 2013, American Medical Systems and its parent company Endo Health, entered into a Master Settlement Agreement with an undisclosed number of mesh-injured patients. The following has been posted on the Securities and Exchange Commission report on the settlement.   The number of litigants is left out as are the Tiers of Injury and
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Endo/American Medical System Sets Aside $520 Million for Mesh Litigation Costs

Feb 26th, 2014 | By

Whether you settle a lawsuit or fight it to the bitter end, it costs a lot to be involved in transvaginal mesh litigation. Endo Health Solutions, the parent company of American Medical Systems (AMS) has set aside approximately $520 million to cover those costs according to its Securities and Exchange Commission filing (SEC) just released
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FDA Approves New American Medical System Transvaginal Mesh Sling

Dec 9th, 2013 | By
FDA Approves New American Medical System Transvaginal Mesh Sling

American Medical Systems (AMS) has just received FDA clearance to market a new incontinence sling, according to a press release that appears in the Wall Street Journal. The RetroArc Retropubic Sling System received the Food the Drug Administration’s 510(k) clearance, a standard that does not require any clinical trials but relies on naming a similar 
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Dr. Twiss Part II: On the Basics of Medicine and Biocompatible Materials for Transvaginal Mesh

Oct 30th, 2013 | By
Dr. Twiss Part II: On the Basics of Medicine and Biocompatible Materials for Transvaginal Mesh

Christian Twiss, MD  is a surgeon at the University of Arizona’s Department of Surgery, division of urology. He is a Board Certified urologist by training with a subspecialty and certification in female pelvic medicine and reconstructive surgery (FPMRS). Dr. Twiss studied with Dr. Shlomo Raz at the University of California Los Angeles (UCLA) between 2006-2008.
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Court Schedule for Bellwether Trials Posted in Upcoming Transvaginal Mesh Cases

Oct 14th, 2013 | By
Court Schedule for Bellwether Trials Posted in Upcoming Transvaginal Mesh Cases

The federal court in Charleston, West Virginia, that has more than 33,000 defective product claims consolidated in something called Multidistrict Litigation (MDL), now has a new section on the website for each MDL bellwether trial. Each of six transvaginal mesh manufacturers will face off with plaintiffs in four jury trials intended to test legal theories
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AMS Granted Limited Discovery into Alleged “Scheme” in Transvaginal Mesh Litigation

Oct 13th, 2013 | By
AMS Granted Limited Discovery into Alleged “Scheme” in Transvaginal Mesh Litigation

On Friday, October 11, AMS, American Medical Systems, was given a limited green light to look into what it alleges could be a fraudulent “scheme” to  stack the deck in the plaintiff’s favor in the ongoing transvaginal mesh litigation. At the same time, those alleged in the questionable activities were granted protection from an overbroad
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Breaking News! AMS Alleges “Scheme” to Profit from Transvaginal Mesh Injuries

Oct 10th, 2013 | By
Breaking News! AMS Alleges “Scheme” to Profit from Transvaginal Mesh Injuries

A Mesh News Desk Exclusive ~ A hearing in federal court in West Virginia, Thursday, will determine whether American Medical Systems (AMS) can pursue allegations of what it calls a “scheme” to create fraudulent transvaginal mesh removal records for profit and to stack the deck against the mesh maker in ongoing federal litigation. The mesh
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Transvaginal Mesh Settlement Talks May be Underway

Sep 30th, 2013 | By

Although unsubstantiated at this time, C.R. Bard and the makers of transvaginal mesh are said to be in settlement talks with lawyers representing 50,000 plaintiffs. This according to Bloomberg but not confirmed by any of the companies involved. The last two lawsuits naming C.R. Bard filed in federal court both settled before the facts went
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C.R. Bard Settles Second Transvaginal Mesh Case for Undisclosed Amount

Sep 16th, 2013 | By
C.R. Bard Settles Second Transvaginal Mesh Case for Undisclosed Amount

The plaintiff’s name is Melanie Vigil and she claimed C.R. Bard’s Avaulta Mesh Suburethral Plus sling, a mesh made of polypropylene, eroded in her body causing internal injuries that led to multiple surgeries. The sling is placed in a  woman’s pelvic region through the vagina (transvaginal) to treat incontinence. Vigil and her husband Mark were
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We hope you find this a helpful resource. National News Editor, Jane Akre, began MDND with the hope of providing the latest news, information and perspective from the regulatory, industry and patient point of view, something that goes under-reported in much of the coverage of medical devices. The public is just now becoming aware that many devices do not undergo the same scrutiny as prescription drugs and are instead grandfathered in under an FDA loophole that has gone largely unchanged since the 1970s. As a result, patients become the post-market clinical trial subjects, and many suffer devastating and permanent injuries.