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.
Please share what you have learned!
Twitter: @JjrkCh

Friday, May 31, 2013

Tuesday, May 28, 2013

'Flawed from legislative foundation': FDA June 13, 2013

The purpose of the meeting is to discuss FDA’s past, present, and future policy on 510(k) Modifications with external stakeholders. FDA seeks comment from stakeholders on different options, both in the form of submissions to the docket for the Federal Register notice associated with this meeting and in discussion during the public meeting. FDA also seeks actual examples of device modifications that industry has made in order to help the Agency develop its policy. FDA expects to discuss the following options:
1.             Potential use of risk management in 510(k) device modifications decisions – can FDA incorporate risk management into its policy on how to determine whether device modifications require new 510(k) submissions in a way that ensures appropriate and consistent decisions by industry and FDA staff?
2.             Potential reliance on design controls activities – FDA seeks proposals for how industry and FDA could utilize design control activities such as design verification and validation to ensure that device modifications are appropriately evaluated prior to marketing.
3.             Potential use of critical specifications – FDA seeks proposals on whether it could incorporate the use of critical specifications in its policy on how to determine whether devices modifications require new 510(k) submissions in a way that ensures appropriate and consistent decisions by industry and FDA staff.
4.             Potential risk-based stratification of medical devices for 510(k) modification purposes – FDA seeks input on the practicality of stratifying devices that require 510(k)s by risk, where lower risk devices would not require 510(k)s for most modifications, if those modifications are part of periodic reports submitted to the Agency.
5.             Potential periodic reporting – FDA seeks comments on the possibility of requiring periodic reporting for legally marketed 510(k) devices.
6.             Potential other solutions – FDA seeks comments on combinations of the options above, or other options not mentioned here.

Date, Time and Location
This meeting will be held on June 13, 2013 beginning at 9 a.m at the following location:
FDA White Oak Campus10903 New Hampshire AvenueBldg. 31, Room 1503 (the Great Room), Silver Spring, MD, 20993
                FDA Campus Information
This public meeting will also be Webcast. Persons interested in viewing the Webcast must register online by 5 p.m. on May 30, 2013. Organizations are requested to register all participants, but to view using one connection per location. Webcast participants will be sent technical system requirements after registration and will be sent connection access information after May 31, 2013.  If you have never attended a Connect Pro event, test your connection.  A quick overview of the Connect Pro program is also available.
Preliminary Agenda (All times are tentative)
9:00 AM
9:15 AM
FDA Presentation
10:00 AM
External Stakeholder Presentations
11:00 AM
11:15 AM
External Stakeholder Presentations, continued
12:15 PM
1:15 PM
External Stakeholder Presentations, continued
2:15 PM
2:30 PM
Panel Discussion
3:45 PM
Open Comment Period
4:15 PM
FDA Close-out
4:30 PM
Registration to Attend the Meeting
If you wish to attend this meeting, you must register by close of business on Thursday, May 30, 2013.  
There is no fee to register for the meeting and registration will be on a first-come, first-served basis.  Early registration is recommended because seating is limited.
In order to permit the widest possible opportunity to obtain public comment, FDA is soliciting either electronic or written comments on all aspects of the meeting topics.  FDA would like to receive these comments by May 30, 2013, so they can be discussed during the meeting, however, comments related to this meeting will be accepted until July 13, 2013.
Regardless of attendance at the meeting, interested persons may submit either written comments regarding this document to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm.1061, Rockville, MD 20852 or electronic comments to
If you wish to make an oral presentation during any of the open comment sessions at the meeting you must indicate this at the time of registration. FDA requests that presentations focus on the topics defined in the Federal Register Notice. You should also identify which discussion topic you wish to address in your presentation. In order to keep each open session focused on the discussion topic at hand, each oral presentation should address only one discussion topic. FDA will do its best to accommodate requests to speak. FDA will determine the amount of time allotted to each presenter and the approximate time each oral presentation is to begin, and will select and notify participants by June 3, 2013.  If selected for presentation, any presentation materials must be emailed to Michael Ryan, no later than June 6, 2013. No commercial or promotional material will be permitted to be presented or distributed at the meeting.
Workshop Details
Food and Beverages will be available for purchase during the breaks.
If you require special accommodations due to a disability, or need additional information regarding registration,  please contact Joyce Raines,Office of Communications, Education, and Radiation Programs, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Avenue, Bldg. 66, Silver Spring, MD 20993, 301-796-5709, FAX: 301-847-8142,
Contact Us
For questions regarding meeting content please contact:
Michael J. Ryan
Center for Devices and Radiological Health
Food and Drug Administration
10903 New Hampshire Ave.
Bldg. 66, rm. 1615
Silver Spring, MD 20993-0002
Phone: 301-796-6283,

My comment:  FDA-2013-N-0430-0001  May 29, 2013 at 6:45pm CT
510(k) Device Modifications: Deciding When to Submit a 510(k) for a Change to an Existing Device
Question D: Risk-Based Stratification of Medical Devices for 510(k) Modifications Purposes
The 510(k) process is not patient centered and this omission causes patient harm.  FDA perpetuates harm by allowing the public to believe that there is scientific research/clinical study performed prior to marketing and implantation of a device.  In addition, the public believes that if a device proves defective, unsafe or ineffective (as in a consumer product failure) the harmed patient will have rights to justice and be cared for medically and financially and any future preventable harm will be stopped.  In fact, the medical provider is not legally responsible for notifying FDA if there is an adverse event with an implant, unless there is a fatality.  In addition, the FDA is not charged with providing an independent investigation of the event.  The harmed patient is charged with finding a lawyer willing to file a lawsuit (often in federal court) and risk their careers on a lawsuit that will cost them more than it will return financially (tort reform limits settlements).  The 510(k) serves to perpetuate the bureaucracy of the FDA, profit the entitled medical device industry and imperil patient safety.  Joint replacement is now the #1 category of expenditure of Medicare yet UDI’s (unique device identifiers) and post market surveillance is lagging.  The U.S. public is paying for countless unproven implanted medical devices that fail and many patients require long-term rehabilitation, often at public expense.

On July 29, 2011 the Institute of Medicine returned a FDA commissioned study report to FDA/CDRH stating
The committee finds that the current 510(k) process is flawed based on its legislative foundation. Rather than continuing to modify the 35-year-old 510(k) process, the committee concludes that the FDA’s finite resources would be better invested in developing an integrated premarket and postmarket regulatory framework that provides a reasonable assurance of safety and effectiveness throughout the device life cycle.”
Given that the FDA/CDRH rejected this advice via FDA/CDRH Director Dr. Jeffrey Shuren’s press release (that day) stating “FDA believes that the 510(k) process should not be eliminated . . .” 
According to Barry Meier of the New York Times  “As of October 2011, some 3,500 patients had filed a lawsuit involving that (J&J DePuy metal-on-metal hip) device.
There is no data on the number of all-metal hips that have failed prematurely in this country because the outcomes of orthopedic procedures are not formally tracked by the government or private companies.”
Jane Akre, on May 24, 2013 reports on Mesh Medical Device News Desk that “21,257 Cases Filed in Federal Transvaginal Mesh Litigation.”  These harmed women have implanted surgical mesh complications that prevent them from having sexual relations, may develop auto-immune disorders, experience extreme pain, may be prevented from returning to work and normal activities for a permanently implanted failed product that was cleared via 510(k).
Stop patient harm.  Follow the IOM instructions to design a system for scientific evaluation of patient harm/risk designed for protection from dangerous and unnecessary medical device implants. 
Steven Baker (MedWatch adverse event #5009052)
Joleen Chambers  (completed training workshop for FDA/CDRHPatient Representative, September 2010)

Monday, May 20, 2013

ProPublica Quantifies & Personalizes Hospital Patient Harm: Interactive

Press this link and participate in this interactive session on hospital hazards.

The Story Behind Our Hospital Interactive

Here at ProPublica, we love to find new ways to tell stories. We’ve built data-driven news apps, commissioned our own news songs and crafted narratives with a novelist’s touch, all to enrich our investigative reporting.
Your Hospital May Be Hazardous To Your Health,” co-published today with PBS Frontline, is our newest try at innovation. And it had an unusual gestation – as part of a five-day hackathon that brought together teams of journalists, filmmakers, developers and designers to produce interactive stories for the Web.
The piece draws from ongoing reporting about patient safetyby ProPublica reporters Marshall Allen and Olga Pierce. Our collaborators were documentary filmmakers Tom Jennings and Sabrina Shankman and Director of Development Sam Bailey, all with Frontline, and a team from Ocupop, a web design and development group based in Milwaukee, Wisc.
The hackathon – “Tribeca Hacks: Storytelling Innovation Lab” – is a project of the Tribeca Film Institute and Mozilla that is supported by the Ford Foundation.

Friday, May 17, 2013

Failed Implanted Medical Device 'phased out'

J.&J. Unit Phasing Out All-Metal Hip Devices

The orthopedic unit of Johnson & Johnson said Thursday that it was phasing out production of all-metal replacement hips, a move reflecting an industrywide trend to abandon the once widely used implants because of high early failure rates.
In 2010, the company, DePuy Orthopaedics, recalled an all-metal model known as the Articular Surface Replacement, or A.S.R., because it was failing just a few years after implant. Typically, artificial hips made from materials like plastic and metal last 15 years or more before they wear out and need to be replaced.
But after that recall, the company continued to sell an all-metal version of a popular hip model called the Pinnacle. In doing so, DePuy insisted that the all-metal Pinnacle was safe and performing on par with other hip replacements, a position it reiterated on Thursday.
It is estimated that all-metal replacement hips — in which both the cup and ball of a device are made from metal — once accounted for about one in three hip implants used in the United States. However, the metal components rubbed against each other as a patient moved, creating tiny particles that could damage tissue, muscle and bone.
Johnson & Johnson is facing a wave of lawsuits from patients who say they were injured when all-metal implants sold by the company failed. It faces over 10,000 cases related to the A.S.R. and 3,300 cases related to the all-metal Pinnacle, according to a company filing with the Securities and Exchange Commission
In a statement Thursday, DePuy pointed to two factors behind its decision to drop the all-metal Pinnacle: sharply declining surgeon demand for all-metal devices and a recent ruling by the Food and Drug Administration affecting such products.
In January, the agency told producers of all-metal hips that any models that were cleared for sale through a regulatory route that did not require premarket clinical testing in patients would have to run such studies to continue selling them.
“DePuy has communicated to the F.D.A. its decision not to pursue” such studies for the device, the company said in its statement.
The company said it was also discontinuing sales of a metal component that can be used with a ceramic hip implant called the Complete. Sales of the metal component used in both the Pinnacle and the Complete will end in August, the company said

Thursday, May 16, 2013

FDA Patient Network Town Hall Live Chat May 21

May 21 FDA Patient Network Town Hall

Join a Live Chat

Upcoming Events - ***you must follow the link above and sign up on the FDA webpage****
Tuesday   May 21, 2013 - 
3:00pm to 4:00pm ET 
2:00pm to 3:00pm CT
1:00pm to 2:00pm PT
Join the FDA Office of Health and Constituent Affairs in a live chat with the director of it's patient liaison team, Richard Klein, to discuss the new FDA Patient Network and how patients can engage with the agency.  The live chat will be in the format of a town hall, allowing patients and patient advocates to discuss FDA's various mechanisms for including the patient perspective into regulatory decision-making, and how the new FDA Patient Network will facilitate broader patient engagement.

Wall Street Journal on Surgical Mesh Post-Market Surveillance Study

Updated May 14, 2013, 4:08 p.m. ET

By SHIRLEY S. WANG   Wall Street Journal   FiDA highlight
A new study finds that long-term benefits are limited for many women who undergo an operation to treat a common condition called pelvic organ prolapse, which can lead to urinary problems and discomfort.
The surgery, called abdominal sacrocolpopexy, has been the standard treatment for the gynecological condition for more than three decades, but its outcomes rarely have been studied systematically beyond two years. In addition, there isn't agreement among doctors about what constitutes success for the procedure.
In pelvic organ prolapse, the uterus or vaginal walls "drop" after childbirth and sometimes protrude into or out of the vaginal opening. Most women who have had children vaginally have some degree of prolapse but may not notice symptoms, which can include feeling a bulge in the vagina, a delay in urinary stream and difficulty with defecation.
For some 225,000 women a year in the U.S., the symptoms become so problematic that they get surgery.
Two procedures, abdominal sacrocolpopexy and a type of vaginal surgery, are used to prop up or anchor the organs to keep them in place, sometimes with the use of synthetic mesh. A third operation, used only rarely for older women, closes up the vagina.
The new study, published Tuesday in JAMA, the Journal of the American Medical Association, followed the outcome of more than 200 women for an average of seven years after sacrocolpopexy surgery. It is one of the longest follow-ups to date of such patients.
The study showed that many women receive short-term relief from symptoms and most don't need repeat surgery, but a substantial portion—some 25%—see some symptoms recur over time, and more than 60% develop urinary incontinence, sometimes as a result of the surgery itself.
"Surgery for pelvic organ prolapse isn't perfect," said Ingrid Nygaard, first author on the study and a professor of obstetrics and gynecology at the University of Utah School of Medicine. "It is very good at alleviating symptoms and improving quality of life, but the results may not last forever."
For those who had mesh implanted as part of the procedure, some 10% experienced movement of the mesh from its original location, which "may cause problems for years down the road," said Dr. Nygaard.
The use of synthetic mesh in a related pelvic organ prolapse procedure, in which the mesh is inserted through the vagina rather than through the abdomen, is the subject of hundreds of product-liability lawsuits against mesh makers. The suits allege the women were injured when the mesh failed.
Mesh contraction can occur in the vaginal procedure and cause pain, but mesh movement with the abdominal surgery is unlikely to be painful, according to Dr. Nygaard, who has no ties with mesh makers.
Strategies to prevent pelvic organ prolapse center on pelvic-muscle exercises and childbirth through cesarean section. Some studies have shown such exercises to be effective, and one large epidemiological study in Sweden suggested a link between C-sections and lower risk of the condition. But the preventive effect of C-sections hasn't been studied in a randomized trial.

Further reading:

Jane Akre:  Mesh Device News Desk

 Ingrid Nygaard:
Study Press Release:

JAMA study: