Media Has Role in Exposing Unsafe Medical Devices!

Why the media must play a bigger role in policing unsafe medical devices

Trudy Lieberman  October 27, 2015

Contributor Trudy Lieberman has been tracking the progress of industry-friendly regulatory legislation — the 21st Century Cures Act — through Congress. Here she examines how current medical device regulations are already allowing many faulty devices on the market — and how the media will need to be more vigilant if and when current regulations are further weakened under 21st Century Cures.  

Last September, the Food and Drug Administration convened a panel of experts to publicly examine the safety of Essure, a birth control device sold to more than half a million women over the past 13 years. The device, a coil implanted in a woman’s fallopian tubes, was sold as a way to permanently prevent pregnancies without the need for abdominal surgery and general anesthesia. Despite the touted advantages, more than 5,000 women have reported complications to the FDA, including tubal perforations, allergic reactions, severe pain and bleeding resulting in hysterectomies and hundreds of unintended pregnancies. In the last few years those complaints have multiplied, and more than 20,000 women have turned to Facebook to share their experiences.

Through the years Essure has gotten its share of press, but media coverage has swelled in the past month thanks to the power of Facebook, the FDA’s expert panel meeting, and a study released this month in The BMJ, which concluded that Essure was not associated with a higher risk of unintended pregnancies but was associated with a substantially increased risk of additional operations to fix the complications arising from use of the device. Outlets such as Reuters, the Wall Street Journal, NBC, and the Philadelphia Inquirer ran stories.  A New York Times editorial called for the FDA to consider suspending sales of Essure until better data is available.

In early September, a few weeks before the FDA hearing, came more troubling news about a different medical device–the C.R. Bard Recovery filter.  The Bard Recovery filter is inserted into the body’s largest vein and is intended to prevent blood clots that form in the legs from traveling to the heart and lungs. In a two-part series, which moved beyond the usual safe topics of network news, NBC reported that the filter could migrate through the body, puncture the heart, and had caused 27 deaths and 300 non-fatal medical events. Neither the FDA nor the manufacturer C.R. Bard would talk about the device or NBC’s revelation that Bard may have forged the signature of its employee who refused to sign off on the FDA approval application because of unresolved safety issues. (They did issue statements — see here and here.) Although NBC pointed out that some 20,000 people were estimated to be walking around with the device implanted in their bodies as far back as 2006, it was disappointing that the story of the migrating heart filter received so little media traction except from trade pubs like Fierce Medical Devices and websites sponsored by law firms no doubt trolling for clients.

As good as the NBC story was, it may have gotten more attention had NBC noted that the FDA had sent Bard a warning letter in July which flagged violations of the Food, Drug, and Cosmetics Act. The FDA said Bard had manufactured and marketed its Recovery Cone Removal System, intended to remove Bard filters from the body, without the required clearance or approval from the agency. The warning letter also advised the company that its “complaint investigation procedures do not ensure product complaints are adequately evaluated.” One case was reported by the company as a malfunction of a medical device when it “should have been filed as a death;” others were filed as malfunctions when they should have been filed as “serious injuries,” the FDA said. Scary stuff the public might want to know! When I asked NBC about this omission, a PR official said the letter “was not germane to the heart of our report,” but noted the warning and other legal and regulatory issues facing Bard were discussed in an online piece. The brief online mention, however, hardly communicated the seriousness of the warning.

Media interest in medical devices is a hit or miss affair, and when there is coverage, it usually doesn’t mean that the device, no matter what harm it may have caused, will be pulled from the market. Such devices continue to be sold, potentially causing more harm. The FDA’s response is often to call for stronger warnings or restricted use rather than ask the manufacturer to recall the device. The rationale: It may still help some people. It also helps the seller’s bottom line. In Washington’s current regulatory climate regulated industries rule the roost.

Most devices are approved with very little evidence they work and are safe.

Bard’s Recovery filter, for example, was approved in 2003, but two years later the company took it off the market and swapped it for a different model. Modifications in the new device were intended to prevent complications that had occurred. Both devices were approved under what’s called the 510(k) approval process that allows manufacturers to avoid conducting safety studies if a device is substantially equivalent to another already on the market. Essure was approved in 2002 on the basis of two nonrandomized, nonblinded prospective studies that lacked a comparison group. Since then some post-marketing studies have found problems.

FDA’s panel of experts concluded “that additional research needs to be done” to prove the device is safe, and they called for its use to be limited.  It’s not clear what action the FDA will eventually take.

“Once the device has been implanted and used, it’s hard to pull back because it has become the expected way of practicing medicine,” says Sanket Dhruva, a cardiologist and clinical scholar at Yale. “In the U.S. there’s no systematic reassessment of device safety and effectiveness years later.” And there’s no systematic, comprehensive, and uniform way of collecting complaints through product registries that other countries have which track problems with medical devices. Medical specialty organizations, the government, and even manufacturers sponsor registries in the U.S. Jeff Lerner, who heads ECRI, the independent organization that tests medical devices, drugs, and other healthcare technologies, told me, “A lot of information comes from registries outside the U.S.”

These shortcomings in policing unsafe medical devices argue for increased media scrutiny, including from social media. (Facebook acted as kind of a registry in the Essure controversy, but consumer complaints–as important as they may be–are no substitute for official registries with controls and rigorous data collection practices.) “The press is absolutely critical,” says Dr. Hooman Noorchashm, a cardiologist, who has spent the last few years trying to get a device called the power morcellator off the market. The device treats uterine fibroid tumors but can also spread hidden cancers throughout the body. Noorschashm and his wife, Amy Reed, also a physician who has cancer thought to have been spread by the morcellator, have been on something of a crusade to warn others and challenge the FDA. “Any success we’ve had is because a few Wall Street Journal reporters listened to us,” Noorchashm told me. So far one manufacturer has pulled the product, and the FDA has called for a black box warning, the strictest cautionary label a product can have. “They put out a black box warning and an advisory. That doesn’t protect patients,” he says. “Doctors still think it’s okay.” One Dallas gynecologist  told the Wall Street Journal that he asks patients to sign an informed consent document describing the risks of the procedure, but he added: “We tell them verbally that we don’t think those numbers are correct.”

As the 21st Century Cures Act moves closer to becoming law, media vigilance over medical devices will be even more crucial. The Senate is now considering the bill, which passed the House in July, and the PR campaign to speed up passage is gaining momentum. Earlier this month the Manhattan Institute, a conservative think tank that has provided the intellectual ammunition for the legislation, bought a full-page ad in the New York Times arguing “a new era in science and medicine calls for a new approach at the federal Food and Drug Administration…every American has a stake in this change because everyone will be a patient someday.” The Act would make it easier for devices to pour into the market in this “new golden age of medicine” the ad proclaimed. As I wrote in a previous post, should 21st Century Cures become law, devices will get even less regulatory scrutiny than they get now. Of course, there can be studies after a device has been around for awhile, but research published this summer in JAMA found that post-market studies varied in quality and only about 13 percent were completed between three and five years after approval. That’s a lot of time during which a bad device can be causing harm to unsuspecting patients.

I asked one of the study’s authors, Dr. Joseph Ross, an associate professor of medicine at Yale, how media coverage of devices could be better. Too often, he said, reporters who do cover devices don’t go far enough. “When you stop at the bad event, it doesn’t illustrate the path that got us there.” The larger story is really about the FDA, America’s laissez-faire philosophy of regulation, its insatiable appetite for cures, and the clash of these elements with costs and safety. That story is much harder to tell.

http://www.healthnewsreview.org/2015/10/why-the-media-must-play-a-bigger-role-in-policing-unsafe-medical-devices/

FiDA comment

Trudy Lieberman, thank you!  The media is welcome to review the chronicle of the medical device industry unearned entitlements and the FDA lax enforcement of regulation that I have collected since 9/2010 when I was invited and attended FDA/CDRH Patient Representative training.  OSHI (office of special health issues) never selected me for a panel because a) most (98%+) devices are grandfathered in by 510(k) process and b) they select the Patient Representative that has no opinion about the product.  So, in effect, the harmed patients are not in the room when decisions are made.  No wonder the profit flows along with the harm!  My blog:  FiDA  Failed implant Device Alliance  http://fida-advocate.blogspot.com

27 Fatalities of Implanted Device: C.R. Bard CEO Sells $7M Shares

Medical Device to Prevent Blood Clots Associated With 27 Fatalities (Video link 4:37)

by TIM SANDLER, STACEY NAGGIAR and STEPHANIE GOSK

September 3, 2015

Serious questions are being raised about a medical device implanted in thousands of Americans at risk for blood clots — including whether the manufacturer told all it knew about potentially fatal flaws.

At least 27 deaths have been associated with the Recovery filter — a spider-shaped apparatus that is inserted into the largest vein in the body — over the course of a decade, an NBC News investigation has found.

Government data shows approximately 300 other non-fatal problems have also been reported with the Recovery, which is one of thousands of medical products sold by C.R. Bard.

Dodi Froehlich, 45, got hers after severe injuries in a 2004 car accident put her at high risk for clots. The filter was supposed to stop them from reaching her heart or lungs; instead, it nearly killed her.

Four months after it was implanted, she developed a severe headache and passed out.

"In that two seconds of being in the ambulance, I started flat-lining," Froehlich told NBC News.

Testing revealed a piece of the filter had broken off and pierced her heart, and she had to have emergency open-heart surgery.

"My family was notified," she said. "The priest was brought in."

Surgeons were able to remove the broken piece during emergency open-heart surgery and save Froelich's life, but not all Recovery recipients have been so lucky.

Gloria Adams, then 55, needed a filter after a brain aneurysm in 2004. Her son Kevin Keech says "everything was fine" when she was discharged from the hospital — but a week later, she was dead.

An autopsy showed that instead of the filter stopping a clot, a clot pushed the entire device into her heart, puncturing it.

"I didn't get many answers at that point," her son said.

After the problems with the Recovery began, Bard hired public-relations giant Hill and Knowlton. The firm circulated a crisis management plan to Bard management, warning that "unfavorable press" could damage stock prices and ruin reputations. The company also retained an outside doctor to conduct a confidential study, which was obtained by NBC News.

The consultant found the Recovery filter had higher rates of relative risk for death, filter fracture and movement than all its competitors.

"Further investigation...is urgently warranted," the doctor wrote.

But even as death and injury reports were climbing, the company decided not to recall the Recovery. Instead, Bard sold about 34,000 of them for nearly three years before replacing them with a modified version with a new name, G2.

Each year, about a quarter of a million blood clot filters are implanted in patients who can't tolerate blood thinners, most without incident. Eleven companies sell them in the U.S., but Bard's Recovery filter stood out early as a risky device.

Bard officials declined NBC News' requests for interviews but in a statement said all its filters have been "appropriately cleared by [the] FDA based on required and accurate documentation and that when used as instructed they demonstrate "significant benefits to patients."

Getting FDA clearance took more than one attempt. After the agency rejected one application for the Recovery, Bard, in 2002, recruited Kay Fuller, a veteran regulatory specialist, to help try again.

In an exclusive interview with NBC News, Fuller raised questions about how Bard handled that application.

She says the company did not give her important safety performance test results and that a small clinical trial raised red flags.

"I was pretty concerned there were going to be problems with this product," she said.

However, when she voiced those concerns, she said, the message she got was that she would be removed from the team if she continued to pursue the matter.

"I was shocked," she said.

Read Part Two of NBC News' Investigation tomorrow: Did C.R. Bard forge Kay Fuller's signature on a key document submitted to the FDA?

http://www.nbcnews.com/health/health-news/did-blood-clot-filter-used-thousands-americans-have-fatal-flaw-n384536

@NBCNightlyNews

@StephGosk

http://www.dakotafinancialnews.com/insider-selling-timothy-m-ring-sells-40000-shares-of-c-r-bard-stock-bcr/405340/

Insider Selling: Timothy M. Ring Sells 40,000 Shares of C R Bard Stock (BCR)

September 3rd, 2015 - 

C R Bard (NYSE:BCR) CEO Timothy M. Ring sold 40,000 shares of the stock in a transaction that occurred on Monday, August 31st. The stock was sold at an average price of $195.17, for a total value of $7,806,800.00. Following the transaction, the chief executive officer now owns 119,694 shares in the company, valued at approximately $23,360,677.98. The sale was disclosed in a filing with the Securities & Exchange Commission, which is available at this link.

Several equities research analysts recently commented on BCR shares. Zacks raised C R Bard from a “hold” rating to a “buy” rating and set a $194.00 target price for the company in a research note on Wednesday, June 24th. Goldman Sachs raised C R Bard from a “neutral” rating to a “buy” rating and lifted their price objective for the company from $193.00 to $220.00 in a research note on Thursday, August 27th. TheStreet cut C R Bard from a “strong-buy” rating to a “hold” rating in a report on Monday, August 24th. Brean Capital reiterated a “hold” rating on shares of C R Bard in a research note on Thursday, July 23rd. Finally, KeyBanc began coverage on shares of C R Bard in a research note on Thursday, August 27th. They issued a “sector weight” rating for the company. Seven investment analysts have rated the stock with a hold rating and four have issued a buy rating to the company. C R Bard presently has a consensus rating of “Hold” and a consensus target price of $193.38.

Shares of C R Bard (NYSE:BCR) traded up 2.30% during mid-day trading on Wednesday, hitting $191.86. The company had a trading volume of 512,486 shares. The stock’s 50-day moving average is $191.45 and its 200-day moving average is $176.17. The stock has a market cap of $14.24 billion and a price-to-earnings ratio of 42.34. C R Bard has a 52-week low of $141.49 and a 52-week high of $202.47.

C R Bard (NYSE:BCR) last announced its earnings results on Thursday, July 23rd. The company reported $2.27 earnings per share (EPS) for the quarter, topping the Zacks’ consensus estimate of $2.18 by $0.09. During the same period in the previous year, the firm posted $2.06 earnings per share. The business had revenue of $859.80 million for the quarter, compared to analysts’ expectations of $836.18 million. The firm’s revenue was up 4.0% compared to the same quarter last year. Equities analysts forecast that C R Bard will post $9.08 earnings per share for the current year.

Catastrophically harmed by surgical mesh? Justice in settlements?

Progress Continues TowardSettling Coloplast Mesh Lawsuits: Report

By: Austin Kirk | Published: June 25th, 2014

As hundreds of Coloplast mesh lawsuits continue to move forward through the federal court system, the parties are continuing to make progress in settlement negotiations to resolve the litigation, according to a recent court update.

Coloplast Corp. currently faces nearly 1,500 federal transvaginal mesh and bladder sling lawsuits, which have all been consolidated for pretrial proceedings before U.S. District Judge Joseph R. Goodwin in the Southern District of West Virginia as part of an MDL, or multidistrict litigation.

All of the complaints involve similar allegations that women suffered severe and debilitating complications after receiving Coloplast mesh for surgical repair of pelvic organ prolapse (POP) or female stress urinary incontinence (SUI), where the mesh eroded through the vagina, caused infections or other injury.

According to a pretrial order (PDF) issued by Judge Goodwin on June 16, “substantial progress” has been made toward settling the Coloplast cases and a follow up status conference has been scheduled for August 7, at which time the parties will meet with Judge Goodwin in chambers to provide an updated report.

In March, it was reported that a Coloplast mesh settlement was reached to resolve about 400 cases for $16 million.

In addition to lawsuits against Coloplast, Judge Goodwin is also presiding over thousands of similar cases brought against manufacturers of other transvaginal mesh products, including C.R. Bard, American Medical Systems (AMS), Ethicon, Boston Scientific, Cook Medical and Neomedic.

Endo Health Systems reported last month that it has agreed to pay $830 million to settle AMS mesh lawsuits brought by about 22,000 women, making it the largest settlement reported to date in the litigation.

C.R. Bard has also reached a number of individual settlements involving cases that were scheduled to come up for trial, but no global settlement agreement has been reached.

Vaginal Mesh Litigation Update

According to the latest case list (PDF) released by the U.S. Judicial Panel on Multidistrict Litigation (JPML) on June 16, Judge Goodwin is currently presiding over 17,812 AMS mesh lawsuits, 18,176 Ethicon mesh lawsuits, 12,004 Boston Scientific mesh lawsuits, 8,555 Bard Avaulta mesh lawsuits, 1,468 Coloplast mesh lawsuits, 195 Cook Medical mesh lawsuits and about 52 Neomedic mesh lawsuits.

The combined total of 58,262 vaginal mesh claims pending in the federal court system represents a nearly 35% increase in the number of cases pending since March 2014, when the U.S. JPML reported that a combined total of 43,173 cases were centralized before Judge Goodwin. In addition, thousands of other cases are pending in various state court systems throughout the country.

As part of the coordinated pretrial proceedings in federal court, Judge Goodwin has scheduled a series of early trial dates involving several of the manufacturers. Known as “bellwether” cases, such test trials are designed to help the parties gauge how juries may respond to certain evidence and testimony that may be repeated throughout the litigation.

In August, a trial involving a lawsuit filed against Ethicon by Jo Huskey is scheduled to go before a federal jury. Huskey alleges that she suffered injuries after receiving an Ethicon TVT-O bladder sling for stress urinary incontinence.

Later this year, a combined trial involving 11 Boston Scientific mesh cases is set to go before a jury starting in October 2014. That case involves women who experienced problems after receiving a Boston Scientific Obtryx sling for repair of stress urinary incontinence.

Last year, a series of three Bard Avaulta trials were set for trial in the MDL, with the first case going before a federal jury in July 2013, involving a lawsuit filed by Donna Cisson. That trial resulted in a $2 million damage award against Bard, including punitive damages designed to punish the company for the actions during the manufacture and sale of the product. The second and third trials were each settled shortly before they were set to begin, with terms of the deals withheld.

Given the lack of progress towards settling additional cases by some manufacturers, Judge Goodwin recently ordered that a second wave of Bard Avaulta cases and Boston Scientific mesh cases be prepared for trial, with hundreds of cases going through case-specific discovery over the remainder of this year so that they can be trial-ready by early 2015.

If the manufacturers fail to reach vaginal mesh settlements to resolve the majority of cases against them, they could face hundreds of individual trial dates scheduled throughout the country next year.

Related Articles

            Coloplast Mesh Settlement Reached To Resolve 400 Lawsuits: Report (3/6/2014)

            Ethicon Prolift Mesh Lawsuits To Be Selected For MDL Trial in Aug. 2014 (9/11/2013)

            Trials for AMS, Ethicon & Boston Scientific Mesh Cases to Begin Dec 2013 (12/11/2012)

            Additional Bellwether Trial Dates Set for Vaginal Mesh Implant Lawsuits (9/5/2012)

            Coloplast Pelvic Mesh Lawsuit Consolidation Sought in W.V. MDL (7/5/2012)

Tags: Bladder Sling, Coloplast, Transvaginal Mesh, Vaginal Mesh, West Virginia

- See more at: http://www.aboutlawsuits.com/coloplast-mesh-settlement-update-66621/#sthash.6t8X8Wjf.dpuf

Public Citizen blasts FDA for weak regulation of implanted surgical mesh.

FDA Wants High-Risk Label forTransvaginal Mesh

Published: Apr 29, 2014

By Charles Bankhead, Staff Writer, MedPage Today, 

Public Health & Policy

FiDA highlight

WASHINGTON -- The FDA has proposed reclassification of surgical mesh for transvaginal repair of pelvic organ prolapse (POP) as a "high-risk device," a designation that mandates an FDA review of safety and effectiveness prior to considering approval.

The agency also wants to reclassify certain instruments used to perform POP repair as "intermediate-risk devices," as opposed to the current low-risk designation.

"The FDA has identified clear risks associated with surgical mesh for the transvaginal repair of pelvic organ prolapse and is now proposing to address those risks for more safe and effective products," William Maisel, MD, of the FDA's Center for Devices and Radiological Health, said in a statement. "If these proposals are finalized, we will require manufacturers to provide premarket clinical data to demonstrate a reasonable assurance of safety and effectiveness for surgical mesh used to treat transvaginal POP repair."

The proposal does not affect surgical mesh used to treat stress urinary incontinence (SUI), abdominal POP repair, hernia repair, and other nonurogynecologic indications. The proposal is subject to a 90-day public-comment period prior to a final decision.

The proposed reclassification follows other FDA actions and statements related to transvaginal POP repair materials going back 6 years:

         October 2008 -- Released a Public Health Notification about serious complications associated with transvaginal placement of surgical mesh for POP and SUI

         July 2011 -- Released an updated safety communication about serious complications associated with transvaginal POP repair with surgical mesh

         July 2011 -- Released a review of urogynecologic surgical mesh adverse events and scientific literature, identifying serious safety and effectiveness concerns

         September 2011 -- FDA's Obstetrics and Gynecology Devices Panel recommended reclassification of surgical mesh for transvaginal POP repair from class II to class III and require premarket approval

         January 2012 -- FDA ordered manufacturers to conduct postmarket surveillance studies to address specific safety and effectiveness concerns about surgical mesh used for transvaginal POP repair

Some materials to repair POP come as kits that include the mesh and instruments used to place, attach, and secure the mesh. Instruments also are sold separately from the mesh, and the FDA proposal to reclassify instruments pertains to the instruments that are not included in kits.

The FDA action represents a case of "too little, too late," according to Michael Carome, director of Public Citizen's Health Research Group, a Washington-based public health advocacy group. Public Citizen has petitioned the FDA to recall all surgical mesh products from the market.

"Today's action comes nearly 3 years after our petition and after an FDA advisory committee recommended such action," Carome said in a statement. "Moreover, the proposed timeline for full implementation of the FDA's order, if finalized, will take several more years.

"As a result of the FDA's reckless delays and inadequate action regarding surgical mesh for transvaginal POP repair, thousands of women will continue to be unnecessarily exposed to a wide array of serious risks, many of which can permanently alter women's quality of life."

All meshed up in Iowa. Stabbed a thousand times a day.

Surgical mesh causes pain, complications in somepatients

February 17, 2014 FiDA highlight added  The Gazette

A 2005 surgery meant to correct Frances Schulte’s (from Coralville, Iowa) urinary incontinence brought her pain and further embarrassment rather than relief.

Doctors implanted a medical device known as surgical mesh, which has since eroded — which means her mesh sling is poking and irritating nearby organs.

“I get stabbed thousands of times a day,” Schulte said. “People don’t understand that I’m in pain every day.”

Schulte, whose surgery was done in Illinois, said that the pain prevents her from comfortably moving around and going to the bathroom.

Surgical mesh, which is generally used to repair weakened or damaged tissue, is made from synthetic material. It is permanently implanted to reinforce a weakened vaginal wall to repair pelvic organ prolapse or to support the urethra to treat urinary incontinence, which can commonly occur in older women, women who have had children and women who are obese.

However, more than 1,000 adverse events were reported to the U.S. Federal Drug Administration between 2005 and 2007, which caused the agency to issue a Public Health Notification in 2008. Since then, the FDA received 2,874 additional reports of complications associated with surgical mesh devices used to repair pelvic organ prolapse.

The most common complications reported to the FDA include mesh erosion through the vagina, pain, infection, bleeding, organ perforation and urinary problems.

“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,” the FDA states on its website.

The FDA has stated that complications associated with the use of surgical mesh have not been linked to a single brand. But Schulte, along with thousands of other women nationwide, opted to seek legal action.

Multiple class-action lawsuits have been filed against various makers of the mesh. Cases against Johnson & Johnson, C.R. Bard, Endo Health Solutions Inc. and Boston Scientific Corp. are all winding their way through federal court in the Southern District of West Virginia.

“I don’t like that they’re still putting it (the mesh) into people,” Schulte said.

Less risky alternatives 

Dr. Catherine Bradley, an OB/GYN and division director of urogynecology and reconstructive pelvic surgery at the University of Iowa Hospitals and Clinics, said that a polypropylene mesh sling was first introduced to the United States in 1998. It was developed by Scandinavian researchers and was tested with promising results.

As the medical device became more popular, other companies began developing similar products, Bradley said.

“I don’t think these were tested as much as they should have been, and the FDA approval was probably inadequate,” she said.

She added that she never used transvaginal mesh for her patients because she was uncomfortable with the studies that had been completed.

Bradley noted that the FDA since has required companies making these products to do more rigorous testing, which can be expensive — this, combined with the class-action lawsuits, has led to some companies to no longer sell the product.

Instead, she opts to treat women suffering from pelvic organ prolapse through surgery without mesh in less severe cases and, when necessary by sacral colpopexy, a less-invasive surgery in which mesh is added through an incision made in the abdomen.

Bradley said there is only about a 5 percent risk of erosion when mesh is implanted this way, compared with a 10 percent and sometimes higher risk of erosion when mesh is applied transvaginally. Removing eroded mesh is difficult, but the removal can help with the pain.

“With abdominal surgery, you are also less likely to have pain than a transvaginal surgery, even one without mesh,” she said.

“As a surgeon who treats women and uses mesh, we complain about how much time we spend talking about it,” she said. “But it’s better that we’re spending more time talking with patients and counseling patients that we can’t always cure (their problems) without complications arising.”

Toxic medical device cartel penetrates government at the highest levels.

 May 13, 2013 by Brian Johnson

J.C. Scott, SVP, government affairs for AdvaMed is named one of the top lobbyists in theBeltway by CEO Update, a publication covering trade councils

AdvaMed's government affairs guru J.C. Scott has been named a "top lobbyist" by CEO Update, a publication that covers the trade association industry.

Scott received praised by the publication for his work on efforts to repeal the medical device tax,. He was one of only two healthcare related lobbyists on the list.

"[Scott] built bipartisan support for repealing the medical device tax, resulting in a nonbinding 79-20 Senate vote,"the publication wrote. "Helped lead Hill efforts to reauthorize user fees, and then to allow FDA to spend the full amount collected."

AdvaMed hired Scott away from the American Council of Life Insurers 2 years ago. He is a Capitol Hill veteran, having cut his teeth on the Hill as deputy director for policy at the House Republican Conference and in a number of capacities for Rep. Deborah Pryce (R-Ohio) before spending seven years at ACLI.

His predecessor, Brett Loper, left Advamed in early 2011 to become the policy director for House Speaker John Boehner (R-Ohio).

Failed Surgical Mesh producer C.R. Bard guilty.

BardLoses $250,000 Verdict in Vaginal-Mesh Implant Trial

By Jef Feeley & Phil Milford - Aug 15, 2013 2:51 PM CT

            C.R. Bard Inc. (BCR) should pay $250,000 to a woman who sued saying she suffered injuries from the company’s vaginal-mesh implant, a jury found.

The first federal-court trial of more than 5,000 claims over the devices now moves to the punitive-damages phase in Charleston, West Virginia.

Jurors deliberated about 12 hours over two days before finding Murray Hill, New Jersey-based Bard liable today for injuries that Donna Cisson blamed on its Avaulta line of devices.

Patients claim the implants cause organ damage and make sexual intercourse painful when they erode. Johnson & Johnson (JNJ), Endo Health Solutions Inc. (ENDP)-formerly American Medical Systems- and Boston Scientific Corp. (BSX) face similar claims that their implants, threaded in place through incisions, degrade and shrink over time.

Cisson’s first trial, in July, ended in a mistrial after a witness began testifying about the devices’ marketing and removal from the market. U.S. District Judge Joseph Goodwin ruled earlier that plaintiffs couldn’t mention that Bard had withdrawn the products.

Scott Lowry, a Bard spokesman, wasn’t immediately available at his New Jersey office to comment on the verdict.

The Bard consolidated cases are In re C.R. Bard Inc. Pelvic Repair System Products Liability Litigation, 10-md-02187, and Cisson’s case is Cisson v. C.R. Bard Inc., 11-cv-00195, U.S. District Court, Southern District of West Virginia (Charleston).

To contact the reporters on this story: Jef Feeley in federal court in Charleston, West Virginia, at jfeeley@bloomberg.net; Phil Milford in Wilmington, Delaware, at pmilford@bloomberg.net.

To contact the editor responsible for this story: Michael Hytha at mhytha@bloomberg.net.

Implanted transvaginal mesh is a bad idea: you think!

Tempers Flare at First FederalTransvaginal Mesh Trial

Posted July 31st, 2013  FiDA highlight

By Doug Allen

CHARLESTON, W.Va. – Physicians dominated the second day of testimony Tuesday in the country’s first federal trial to determine if a transvaginal mesh manufacturer is responsible for injuries to a patient. A doctor who consulted for C.R. Bard Inc. testified that the company knew the resin used to manufacture the mesh should not be permanently implanted in the human body but refused to disclose that to surgeons.

Cisson v. C.R. Bard Inc. is a bellwether case for the more than 23,000 cases involving transvaginal mesh combined in the U.S. District Court for the Southern District of West Virginia. Judge Joseph R. Goodwin is overseeing all of the cases.

In 2009, Dr. Brian Raybon implanted Bard’s Avaulta Plus device into Donna Cisson, the patient at the center of the lawsuit. He spent several hours on the witness stand Tuesday, describing Cisson’s condition and the steps he took to treat it.

Cisson suffered from symptoms like involuntary loss of gas and urine and was diagnosed with pelvic organ prolapse and stress urinary incontinence, Raybon said. He recommended the Avaulta Plus, and Cisson, a nurse, agreed.

“I liked it,” said Raybon, referring to the mesh device. “I felt like it was a good system at that time, and I thought it was appropriate for Mrs. Cisson.”

The urogynecologist from Georgia said he felt confident in the mesh product based on the information he had at the time. He had consulted with Bard on the Avaulta brand for several years, and gained notoriety as the first surgeon to implant an Avaulta product in a patient in the United States.

Concern Grows over Complications

It was only after patients began showing up with complications requiring multiple surgeries to remove the mesh that Raybon discovered the company that manufactured the resin used to make the mesh told Bard it was not to be permanently implanted in the human body.

“How could (Bard) use it with that (warning)?” he asked, when pressed by Cisson’s attorneys. “That’s the part that really concerns me about this. I was astounded when I saw (the warning).”

Under cross-examination, lead defense attorney Lori Cohen pressed Raybon on his failure to contact Bard to ask about the warning, which was disclosed on a Chevron Phillips Material Safety Data Sheet (MSDS) for the resin, once he found out about it.

The jury of four men and four women listened intently as Raybon became visibly agitated and raised his voice while explaining why Bard’s lack of disclosure of the MSDS sheet caused him great concern.

“As someone who spent four or five years at Bard teaching other physicians (about Bard products), and there‘s this MSDS sheet around,” he said. “I’m really concerned I’ve put something in these patients that shouldn’t have been put in. I’m sorry … it was a little irritating to work with someone four or five years, and they didn’t tell me.”

‘Transvaginal Mesh is a Bad Idea’

Late in the afternoon, Dr. Lennox Hoyte, whose response to a question from an attorney caused the first trial to end in a mistrial, returned to the witness stand. Hoyte is a professor of urogynecology and pelvic reconstructive surgery at the University of South Florida, and the chief of urogynecology and robotic surgery at Tampa General Hospital

After being recognized by the court as an expert witness in female pelvic medicine and reconstructive surgery, Hoyte demonstrated how prolapse affects women, using a 3-D model of a woman’s pelvis and a sock.

Hoyte said 50 to 60 percent of women who deliver a baby vaginally will develop some sort of pelvic organ prolapse over time. He also said that he’s performed more than 400 mesh repair operations since 2009, and about 100 of those involved Bard’s Avaulta line.

The net-like device at the heart of the lawsuit includes small mesh “arms” that extend from the device to help hold it in place. Hoyte said he believes the arms are the problem.

“It’s dangerous to go after the arms (during revision surgery) because of the location,” he said.

The mesh implant allows fatty tissue, nerves, blood vessels and muscles to grow through and around it, and Hoyte said it’s not easy to remove. Hematomas (collections of blood) can form, and the vaginal flesh becomes ingrown so tightly around the mesh that surgical removal can destroy so much tissue that the vagina can be difficult to reconstruct.

“Armed transvaginal mesh is a bad idea,” he said. “It never made sense to me. … I always had a feeling the mesh would shrink and cause pain to patients.”

Testimony continues today, with defense attorneys cross-examining Hoyte on Day 3 of what is scheduled to be a 12-day trial.

Doug Allen is a freelance reporter based in Aspen, Colo. His work has appeared in local and national print and radio outlets, including The Washington Post and Aspen Public Radio.

Last modified: July 31, 2013  Drugwatch.com