Joint replacements are the #1 expenditure of Medicare. The process of approving these medical devices is flawed according to the Institute of Medicine. It is time for patients' voices to be heard as stakeholders and for public support for increased medical device industry accountability and heightened protections for patients. Post-market registry. Product warranty. Patient/consumer stakeholder equity. Rescind industry pre-emptions/entitlements. All clinical trials must report all data.
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Friday, November 30, 2012

Astroturf Lobby Group? Where is the Patient Engagement?


The Center for Devices and Radiological Health at the U.S. Food and Drug Administration would like to make you aware of an upcoming event. Next Monday the independent non-profit Medical Device Innovation Consortium (MDIC) will be announcing a new public-private partnership between the MDIC, FDA, other government agencies, non-profits, academia, and the medical device industry designed to address emerging device regulatory science issues.  Additional information on the MDIC can be found at

As key health technology stakeholders, we would be pleased for you to join us to hear the Commissioner discuss this important new initiative. The Consortium is designed to improve outcomes for patients by fostering innovation, increasing the tools available to evaluate new medical devices to make sure they are safe and effective, and to ensure these improvements in care get to patients as expeditiously as possibly while safeguarding public health.

Please join us if you can,

Michelle McMurry-Heath
Associate Director for Science, Acting Chief Scientist
Office of the Center Director
Center for Devices and Radiological Health
U.S. Food and Drug Administration


You are invited to attend the Senate MedTech Caucus briefing:

Monday, December 3rd, 10:30 am – 12:00 pm
Room 106, Dirksen Senate Office Building
Announcing: “Medical Device Innovation Consortium”
Featuring: FDA Commissioner, Margaret Hamburg, M.D. & FDA’s Center for Devices and Radiological Health (CDRH) Director, Jeffrey Shuren, M.D., J.D.

The program will include a briefing on the creation of the Medical Device Innovation Consortium (MDIC).
The MDIC is a Public-Private Partnership (PPP) whose mission is to improve health through the application of shared knowledge in medical device regulatory science.  It is the first-ever PPP created to focus exclusively on advancing medical device regulatory science.
The MDIC will create a collaborative environment where nationwide representatives from industry, non-profits, and FDA can work together to keep pace with the needs of patients in the United States.
Speakers will include:
Senator Amy Klobuchar
Senator Al Franken
FDA Commissioner, Margaret Hamburg, M.D.
FDA’s Center for Devices and Radiological Health (CDRH) Director, Jeffrey Shuren, M.D., J.D.
Centers for Medicare & Medicaid Services, Deputy Director, Coverage & Analysis Group, Tamara Syrek Jensen, J.D.
Immucor, Inc., CEO, William Hawkins
LifeScience Alley CEO, Dale Wahlstrom

The Medical Device Innovation Consortium is a public private partnership whose mission is to improve health through the application of shared knowledge in regulatory science.
Focused on the Medical Device Industry
The MDIC is the only public private partnership focused exclusively on the strategic needs of the medical device industry. The MDIC is designed to create a collaborative environment where the private sector can partner with the FDA’s Center for Devices and Radiological Health to solve technical issues that affect the industry.
Focused on Regulatory Science
Regulatory science refers to the development and evaluation of new tools, methods, standards and applied science that support a better understanding and improved evaluation of product safety, quality, effectiveness, and manufacturing throughout the product life cycle.
Focused on Improving Health
The MDIC has been formed to add value at the intersecting needs of the medical device industry, the FDA, and the related organizations that are together responsible for a vibrant medical device industry that serves the public health needs of the U.S.
Founding Members
Life Science Alley

About Us
The MDIC is the first ever Public Private Partnership (PPP) created with the sole objective of advancing medical device regulatory science. The intent is to be a national 501c(3) organization that operates in partnership with the FDA.
                The PPP relationship was formalized with the signing of a Memorandum of Understanding between LifeScience Alley, Inc., a Minnesota trade association, and the FDA on December 7, 2011. In August 2012, Articles of Incorporation were filed to formally establish the MDIC.
                Membership and participation in the MDIC will be open to representatives of organizations that are substantially involved in medical and/or medical device research, development, treatment, or education; the promotion of public health; or who have expertise in regulatory science.
Governance Structure
The MDIC will be governed by a Board of Directors that will oversee the MDIC’s subcommittees and assist in identifying sources of funding. Subcommittees will represent industry sectors or technology areas (eg. Modeling, interoperability, orthopedics, neurological devices).
                Each subcommittee will be responsible for establishing working groups chartered with identifying key issues affecting their industry segment.
                The working groups will bring forward project plans for prioritization and funding allocation.
What We Do
The MDIC will pursue several strategies in support of its mission:
1.            Create a forum for collaboration and dialogue, working within a flexible governance structure to encourage broad participation from the different industry stakeholders including FDA.
2.            Make strategic investments in regulatory science, utilizing working groups to identify and prioritize key issues and to request, evaluate, and implement project proposals that support the MDIC’s mission.
3.            Provide tools to drive cost effective innovation, emphasizing education and the development of new methods and approaches with well documented data and details to enable implementation.
The activities and output from the MDIC will:
                Ensure innovative technology is readily available to U.S. patients
                Make the medical device regulatory process more expeditious, transparent and effective
                Reduce the risk and expense of clinical research
                Reduce the time and cost of medical device development
The MDIC will accept project proposals specifically focused on advancing medical device regulatory science.
After the initial meeting of the MDIC Board of Directors (early in CY13), the first sector subcommittees will be commissioned.
                The subcommittees will organize working groups to develop rigorous project plans for prioritized topics.
                Detailed project plans will be used to solicit project specific funding from companies who will benefit from their outcome and foundations interested in supporting the initiative.
The advantages of conducting research within the MDIC include:
                Involvement of the FDA at all stages of the work thereby building awareness of and support for specific product development tools and approaches.
                The ability to share best practices across industry and academia.
                Exposure to a range of perspectives representing multiple constituents which can ensure more robust project development and data interpretation.
                A mechanism for sharing the expense of research in the regulatory science, non-competitive domain.

The core operations of the MDIC are funded through contributions from members.
                Pricing for annual membership is determined based upon the operating expenses for the MDIC.
                The goal is to keep the membership low enough to encourage broad, cross-industry participation while still meeting the operational needs of the organization.
                It is anticipated that as the membership base is increased, there is the potential that the dues per member will decrease.
Membership will be offered at several levels based on organization type and, if applicable, annual revenue. Project specific funding will be obtained from companies and foundations as a result of working group development of rigorous project plans.
                $150,000 contribution annually: Companies with annual revenue >$10 B
                $100,000 contribution annually: Companies with annual revenue between $5–10 B
                $50,000 contribution annually: Companies with annual revenue between $1–4.9 B
                $10,000 contribution annually: Companies with annual revenue <$1 B
                $5,000 contribution annually: Nonprofit Sector
Benefits of Membership
The MDIC will provide its members with:
                A mechanism through which to influence the future of the medical device industry by virtue of direct, collaborative discussions and projects with FDA.
                A process for identifying, documenting, prioritizing and removing issues affecting the industry.
                Processes, policies, support staff and pooled project funding to enable efficient regulatory science research in areas of strategic importance to the industry.
                Educational forums in which to learn about the evolving regulatory science process, new tools, standards and test methods.
                Searchable databases and links to relevant reports and methods.
                Regular updates on the status of the MDIC’s activities and opportunities for involvement.

Contact Us
To receive further information and to discuss next steps and membership details, please contact:
Maura Donovan, Ph.D.Interim Executive Director,
Dale WahlstromCEO of LifeScience

Minnesota Device-Makers Join Forces with FDA to Advance Regulatory Science
Regulatory Intelligence | Posted: 8 December 2011
Minnesota-based medical device lobbying group, LifeScience Alley, signed a memorandum of understanding with the US Food and Drug Administration (FDA), making official a year-long partnership to continue developing best practices in regulatory science. Center for Devices & Radiological health chief Dr. Jeffrey Shuren signed the memorandum, formalizing more than a year of joint effort toward developing regulatory science — a set of tools and methods for evaluating the safety, effectiveness, quality and performance of medical devices. If the pilot version of the program works in Minnesota, it may serve as a national model for device safety and clearance. (Mass Device)
Join the discussion on Regulatory Exchange

Sen. Brown co-chairs Medical Technology Caucus
April 4, 2011

WASHINGTON, DCU.S. Senators Scott Brown (R-MA) and Amy Klobuchar (D-MN) announced today that they will serve as co-chairs for the new Senate Medical Technology Caucus in the 112th Congress. The caucus aims to increase awareness about issues facing the medical technology sector, an industry that creates life-saving and life-enhancing innovations that improve patient care.
In Massachusetts, we have more than 200 medical device companies and hundreds of bio and pharma companies, all of which provide good-paying jobs to thousands of citizens,” Brown said. “It is critical that we provide a business environment for them to innovate, grow and thrive. I’m pleased to be the Republican chair of this bipartisan caucus, and look forward to working with my colleagues on both sides of the aisle to give our medical device and technology companies the tools and resources they need to continue their important work.”
“These businesses not only spark medical breakthroughs, they save lives,” Klobuchar said. “Every day in every state small medical technology companies are driving the innovation agenda we need to compete in a global economy. I will continue to work to make sure that Minnesota remains a leader in health care innovation by developing innovative products while maintaining patient safety.”

The United States is the world’s only net exporter of medical devices, with a $5.4-billion annual trade surplus. Minnesota is home to 400 medical device practices that support over 50,000 jobs in the state. The industry provides good-paying jobs to more than 400,000 Americans, with total direct and indirect employment exceeding two million.
Klobuchar has led the effort to cut red tape that threatens innovation in this industry. After a December report surveyed over 200 medical technology companies and found that confusing and contradictory regulations are stifling innovation, Klobuchar and Brown pushed the Food and Drug Administration (FDA) to reform its slow and inconsistent 510(k) approval process for medical devices to maintain safety, protect patients, and encourage innovation. Klobuchar is the chair of the Senate Commerce Subcommittee on Competitiveness, Innovation, and Export Promotion, and plans to hold a hearing to examine the medical device approval process and to examine ways to improve export options.

Thursday, November 29, 2012

Lana Keeton: Patient, Advocate, Victorious!


Breaking News
Major Victory for Women!
 And for Women’s Health Care!
 Dateline: Miami, November 28, 2012
 By Lana C. Keeton (copyright protected)

The Center for Devices and Radiological Health (CDRH) will be up-classifying all Synthetic Surgical Mesh for Pelvic Organ Prolapse repair from Class II to Class III within one year.

Even better, in the very near future, all but one of the most popular prolapse kits, will no longer be sold.

The CDRH will be announcing important new regulations in December. Companies will have to pay an upfront fee of $250,000.00 to be part of a registry along with conducting 3 year clinical trials to prove safety and effectiveness of these “kits” which is not possible and will cost them millions.

And there will be major new requirements for surgeons implanting surgical mesh in the pelvis. No longer will surgeons be able to take a weekend course taught by an industry paid “medical advisor/consultant” to start implanting a filthy petroleum waste by product into women.

Medical mercenaries will now think twice before they mutilate women internally with a foreign body polymer that shrinks, hardens and moves at will within their pelvis mercilessly destroying their lives.

Doctors on the prolapse kit bandwagon who have ignored what they earned in med school about foreign bodies, checked their medical training at the door when they walked into the operating theatre and spouted the ridiculous mantra that foreign body polymers are biocompatible and inert will now be held accountable for their actions. Praise the Lord!!

Just as I was quoted in Bloomberg News in January when the FDA mandated 522 studies of 99 synthetic surgical mesh products used for prolapse and incontinence, industry knows it will not be able to prove these “medical devices” safe or effective and it will cost them millions they are unwilling to spend.

And there it is. It was never about health. It was always about the money, no matter how many millions of people were harmed or put at risk for serious harm or even death.

Now we are seeing the death of insanity in women’s health. Another “Dalkon Shield” bites the dust.

Patients and patient advocates have won a very long and significant battle for the safety of patients who will not be harmed in the future!!
By Alex Nussbaum & David Voreacos - Jan 5, 2012 3:19 PM CT
Johnson & Johnson (JNJ) and C.R. Bard Inc. (BCR) must study rates of organ damage and complications linked to vaginal mesh implants, U.S. regulators said, responding to patient advocates who say the devices have harmed women.
The Food and Drug Administration wrote J&J, C.R. Bard and 31 other manufacturers, telling them to conduct three years of trials on safety and effectiveness, the agency’s William Maisel (see FiDA blog dated 11/2/12 High Standards for FDA Leaders? FDA Official Pleads Guilty to Prostitution Charge, Gets One Day of Probation)  said yesterday in a telephone interview. An FDA report in July found a fivefold jump in deaths, injuries or malfunctions tied to the products.
Almost 300,000 synthetic meshes were implanted in U.S. women in 2010 to treat incontinence or shore up pelvic muscles, the agency estimates. The devices’ alleged failures have spurred more than 650 lawsuits against manufacturers and heightened scrutiny of the FDA program that cleared the products for sale without human testing.
“Now these companies are going to have to tell the truth,” said Lana Keeton, a mesh recipient and patient advocate from Austin, Texas. While companies say implants are safe, “up until now, there’s been no data,” she said. “It’s all been marketing.”
J&J, the biggest maker of vaginal mesh, fell (JNJ) less than 1 percent to $65.40 at the close in New York. C.R. Bard also declined (BCR) less than 1 percent to $85.94. J&J is based in New Brunswick, New Jersey, and C.R. Bard in Murray Hill, New Jersey.
The letters ask each manufacturer to collect data on the results and potential complications of transvaginal procedures, in which the hammock-like meshes are threaded in place through an incision in the vagina. The FDA said in July that it wasn’t clear from available studies whether the devices provided a benefit over older methods in certain cases.
Guiding Doctors
“We believe there are certain uses of mesh where we need additional data to help guide the clinical community,” said Maisel, deputy director of science for the agency’s device- approval center. “Our goal is to make sure the right women use it at the right time.”
The meshes were approved through the FDA’s 510(k) system, which allows products to reach the market without human testing if the agency decides they’re similar to devices already for sale. In October, Bloomberg News reported many implants can trace their approvals back to a Boston Scientific (BSX) Corp. mesh recalled for safety concerns in 1999.
Yesterday’s letters covered only devices already on the market. Consumer groups say they want the action to be just a first step toward requiring studies before the products can reach the market, said Amy Allina, a policy director at the National Women’s Health Network in Washington.
‘The Right Thing’
“It would have been better if the products that had hurt women had never gone out in the first place,” she said in a telephone interview. “But now that they’re out there, we’re encouraged to see the FDA doing the right thing and requiring the companies to provide more information.”
Even before the studies are done, they will serve to warn off patients, said Keeton, the Texas woman and founder of the group Truth in Medicine.
“What woman’s going to sign up for a study when they know” the potential complications, she said by telephone.
Keeton sued J&J over injuries she blamed on a 2001 implant. The case was dismissed by a federal judge in 2007. She has also worked as a paid consultant to lawyers suing mesh makers.
Matthew Johnson, a spokesman for J&J’s Ethicon unit that makes the devices, said the company was reviewing the correspondence from the FDA.
‘Most Studied’
“Ethicon’s transvaginal mesh devices are already among the most studied devices on the market, and we will continue to support their use in surgical repair with clinical evidence, through investigator-initiated and company-sponsored trials,” he said in an e-mail.
The FDA letters also went to companies including Endo Pharmaceuticals Holding Inc. (ENDP) of Chadds Ford, Pennsylvania, and Boston Scientific, based in Natick, Massachusetts. The companies have 30 days to respond.
Kevin Wiggins from Endo Pharmaceuticals and Eric Olson from Boston Scientific didn’t return phone calls seeking comment. Scott Lowry, a C.R. Bard spokesman, also didn’t return a message.
The edges of mesh fibers can constrict or cut into internal organs after they’ve been implanted, studies have found. The procedure is also prone to infection because the vagina through which the devices are inserted isn’t a sterile environment, said Clifford Wheeless, an emeritus associate gynecology professor at Johns Hopkins University (43935MF) School of Medicine, in a telephone interview last year.
In September, an advisory panel recommended the FDA reclassify mesh used for pelvic organ prolapse, a condition in which weakened muscles fail to support internal organs, as “high-risk” devices that require human testing. The FDA hasn’t made a decision yet, Maisel said. The agency isn’t likely to heed the call of some patient advocates for a complete recall, he said.
“There’s strong support in the clinical community that mesh serves a role for certain patients,” Maisel said. “Our goal is not to completely remove these products from the market.”
Manufacturers sell about $175 million worth of prolapse mesh worldwide and another $295 million for incontinence treatments, C.R. Bard executives estimated on a conference call in 2010. Even for the top sellers, the products make up only about 1 percent to 2 percent of sales, said Michael Matson, a Mizuho Securities USA analyst in New York.
“Patients are already well aware of these issues and the markets have been declining already,” he said.
To contact the reporter on this story: Alex Nussbaum in New York at; David Voreacos in Newark, New Jersey at;