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.
Twitter: JjrkCh

Monday, April 30, 2012

ProPublica criticizes implanted medical device oversight.

LINK

Four Medical Implants That Escaped FDA Scrutiny
by Lena Groeger
ProPublica, Today, 11:32 a.m. (Graphs/photos omitted.)
           
Medical devices sustain and improve the quality of life for millions of Americans. But as the over $100 billion-a-year industry pushes thousands of devices to market every year, reports of faulty devices, repeat surgeries, and recalls have increased. The FDA and the industry maintain that a speedy approval process gives patients faster access to life-saving devices. But critics say that unlike drugs, a substantial number of risky devices are cleared without clinical testing, and receive almost no oversight once on the market.
We've taken a closer look at four types of implantable medical devices that have drawn the most criticism.
Hip Implants

Hundreds of thousands of people with advanced arthritis get total hip replacements each year, surgically replacing their hip joint with a prosthetic. Typically, implants are made up of a metal head that rotates inside a plastic cup. But in 2005, Johnson & Johnson's DePuy Orthopaedics introduced a new all-metal design. Maintaining that the new device was substantially equivalent to older models, DePuy got clearance for the hip device without conducting any clinical trials to test how it would perform in patient's bodies. The company was able to do that through an FDA process called 510(k), which doesn't require clinical data as long as manufacturers can show that their new device is "substantially equivalent" to one already on the market.
In the case of DePuy's hip implant, that testing began once the implants went to market.
According to the British Hip Society, the failure rate of the DePuy implant was so high that almost half of all patients who got the implant required surgery within six years to fix problems. The metal was eroding, releasing metallic particles into the blood and surrounding tissue of the joint and causing tremendous pain (the New York Times has an explanatory graphic of this failure.) After thousands of complaints and lawsuits, the device was recalled in 2010, after it had been implanted in almost 100,000 people. DePuy said the company continuously reviewed data about the hip implant while it was on the market, and initiated the recall as soon as new information confirmed a problem.
Last year the Institute of Medicine reviewed the clearance process for medical devices and called for the 510(k) process to be eliminated altogether because it could not guarantee safe devices. They found that from 2005 to 2009, three out of four recalled high-risk devices had not been approved with clinical data, but rather had gone through the 510(k) clearance process or had been exempt from review altogether.
Furthermore, a Government Accountability Office report found that once recalled, many of the highest-risk devices are not corrected or removed from the market.

Surgical Mesh
Implantable surgical mesh acts a reinforcement structure for internal organs, and is often used to treat pelvic organ prolapse or stress urinary incontinence in women.
The FDA first cleared vaginal mesh in the late 1990's based on its similarity to earlier products used to fix internal hernias. Despite using a different method of implantation (inserted through the vaginal wall, rather than with abdominal surgery) and for an entirely different part of the body, surgical mesh "kits" were advertised as a new and improved method to treat urinary incontinence.
In 1999, Boston Scientific voluntarily recalled its surgical mesh product called the ProteGen Sling, after numerous complaints of pain, infections, and injuries. Over a decade later, Johnson & Johnson faced hundreds of lawsuits over a surgical mesh device that was substantially similar (in fact had been cleared based on its similarity) to the ProteGen Sling.
In 2008 the FDA said that surgical mesh complications were serious, but rare. Over the next two years, complaints grew to the thousands, and doctors and patients reported five times as many mesh complications as previous years. According to a 2011 FDA report, total "adverse event" reports for all medical devices – not just mesh – have risen an average of 15 percent a year for the past decade.
In the case of vaginal mesh, the most common problem was mesh eroding and sticking through the walls of the bladder or vagina, causing burning and pain. A study in the journal Obstetrics and Gynecology found that 15 percent of the women treated with vaginal mesh had complications, and that the mesh was no more helpful than other repair treatments. Boston Scientific has repeatedly stated that mesh is a safe and effective treatment option.
In July 2011, the FDA said that serious complications with mesh are "not rare" and may expose patients to more risk. In January of this year, the FDA finally ordered manufacturers to conduct studies of surgical mesh.
Heart Valve Rings
An annuloplasty ring is a circular device used to repair faulty heart valves, by pinching together two flaps that normally prevent blood from leaking back into the lungs or another heart chamber. Given their critical role in sustaining life, the rings were originally classified in the highest risk class. For these very high-risk devices, manufactures often go through a premarket approval (PMA) process, which requires clinical data that a device is safe. But the FDA also clears dozens of high-risk medical devices each year through the less stringent 510(k) process – and over the past decade, that number has increased dramatically.
.In 1997, after being petitioned by manufacturers, the FDA brought the heart valve rings down to a lower risk class, alongside hearing aids and glucose monitors. With a lower risk, manufacturers could more quickly — and cheaply — gain clearance.
In the case of a heart ring called the Myxo ring, the manufacturers Edwards Lifesciences didn't seek clearance through the 510(k) — or any other process. Starting in 2006, the device was implanted in over a hundred people without FDA clearance, which current regulations allow. According to the agency, manufacturers with a cleared device on the market can make changes or modifications to the product without needing to submit an entire new application.
While patients didn't report any major complaints with the ring, many were troubled by the fact that a life-sustaining device could be on the market without any FDA supervision. Edwards Lifesciences maintained the ring was safe, but voluntarily recalled the device and applied for clearance.
In April 2009, after the Myxo ring had been subject to an FDA investigation and a Senate inquiry, the FDA retroactively cleared the device under a new name, saying it was safe. The agency said that Edwards Lifesciences should have sought clearance, but that they made an " honest attempt" to interpret the regulations.

Defibrillator Leads

An x-ray picture of a defibrillator device and lead
Implantable defibrillator leads are wires that connect defibrillators (devices similar to pacemakers) to the heart. Defibrillators automatically monitor and administer shocks to the heart, and a malfunction can cause the device to fire unexpectedly, or fail to fire when a patient's life depends on it. Over the past decade, the $10 billion dollar heart device industry has seen several high profile cases of malfunctioning products that posed severe risks to patients.
The most recent episode concerns the St Jude's Riata lead, which has been implanted in approximately 79,000 people in the United States. Last year the device was recalled after it became clear that electrodes inside the lead could erode out of their lining, exposing electrical wire to the body and potentially causing a short circuit. Manufacturers had known about the problems with the Riata for a while. In fact, a full year before the recall, St. Jude stopped selling the device and sent a letter to doctors describing the problem.
A recent study found that the Riata lead was prone to yet another type of failure (malfunctioning at high voltages) and had been responsible for at least 20 deaths. St. Jude disputed the accuracy of the study, saying it was based on incomplete data. In a recent statement, the company said it has made significant design changes to its newer lead models to address these safety issues, and is also currently conducting an evaluation study of the Riata lead.
Critics point to the Riata lead as an example of FDA failure to adequately monitor devices once they go to market. A Government Accountability Office report found multiple problems with FDA oversight, including a passive system dependent on voluntary reports and a lack of complete information about how devices are used and who uses them.
The FDA says it is currently working on a national surveillance strategy.
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Regina Holliday's Medical Advocacy Blog: The Healthcare Tsunami

Regina Holliday's Medical Advocacy Blog: The Healthcare Tsunami:   The important people were here.    They hung framed as faces on the wall at the National Press Club. The entire venue was dressed i...

Austin, TX movie premier Thursday May 3

LINK
Actor Dennis Quaid and hero-on-the-Hudson pilot Sully Sullenberger are featured in the movie "Surfing the Healthcare Tsunami:  Bring Your Best Board"


 The Austin movie premier event will include a keynote from John Nance, JD, and Charles Denham, MD. A major feature of the evening will be the Austin premiere of TMIT's latest documentary, Surfing the Healthcare Tsunami: Bring Your Best Board™.

Tentative Agenda:
Location: Bass Concert Hall; 2350 Robert Dedman Drive, Austin, TX
                5:00pm - 6:30pm: Registration and networking – Drink and heavy hors d'oeuvres
                6:30pm - 6:35pm: Tom Manley, CEO, TMF – Introduction and welcome
                6:35pm - 7:15pm: Charles Denham, MD and John Nance, JD – A joint plenary presentation titled High-Altitude and High-Performance: The Patient Safety Prospects are Looking Up – An interactive presentation by both speakers together will provide insights to terrific opportunities for hospital leaders to apply lessons learned from aviation to save lives, save money, and bring value to the communities they serve.
                7:15pm - 8:10pm: TMIT Documentary Premiere – Surfing the Healthcare Tsunami: Bring Your Best Board™
                8:10pm - 8:40pm: Break – Refreshments
                8:40pm - 10:00pm: Texas Health Care Quality Improvement Awards Ceremony
                10:30pm: Wrap-up


Surfing the Healthcare Tsunami:
Bring Your Best Board™
TMIT is driving production of multimedia development of stories to improve patient safety in hospitals. Certain broadcast programs will be shown globally, and then will be made available to hospital leadership and front-line performance teams.
Stories will include consumers, front-line caregivers, clinical and non-clinical leaders of hospitals, and international subject matter experts. The series of "arc to action" stories will be told to inspire both community and hospital leaders to act locally.



Required: Documentary Premiere Registration
Register to be a part of this exciting event.
Disclaimer: Space is limited, and filling out the form below does not guarantee that your registration will be accepted.











Saturday, April 28, 2012

New York Times: Medical Device Regulation Weak



EDITORIAL
Cozy Deal
Published: April 28, 2012  New York Times  (FiDA Blog bold added.)
                                   
Congress long ago shirked its responsibility to provide the Food and Drug Administration with sufficient money to do its job. So the companies that make drugs and medical devices — complaining that it took too long to win approval for their products — offered to pay “user fees” if the F.D.A. would hire more people to evaluate their applications. Critics charge that those cozy cash-fed agreements have given industry far too much influence over the regulatory process. Industry says that without the money, patients would have to wait far too long to get access to new treatments.
The F.D.A. needs more resources to do reviews. But Congress, which must ratify a new round of deals by the end of the year, needs to do a better job of ensuring that regulations are not weakened in the process.
The user fees, which cover more than 60 percent of the cost of reviewing drug applications and 20 percent of reviewing devices, have cut F.D.A. review times. But legitimate concerns have been raised that the negotiations have given away too much to industry — with too much emphasis on quick approvals while weakening protections, like the quick removal from the market of drugs or devices that are found to be dangerous.
In some cases Congress, heavily lobbied by industry, has impeded the F.D.A.’s ability to act, as when it required the agency to use the “least burdensome” approach for seeking information from industry. In some cases, the agency seems to have been loath to bite the hand that is financing it. A survey last year by the Union of Concerned Scientists found that 40 percent of the agency’s scientists felt that the consideration accorded to business interests was “too high.” A recent report from Public Citizen, a consumer advocacy group, noted that device-related deaths had been running above 2,000 a year and the average number of high-risk and moderate-risk recalls had doubled in recent years.
Regulation of devices has always been far less rigorous than drug regulation, and last week the Senate health committee approved a bill that would partly address that problem by beefing up the agency’s ability to require post-market surveys of medical devices and impose more stringent rules on devices that raise safety concerns.
But the Senate bill and pending House legislation would fail to close a worrying loophole. Currently, the vast majority of medical devices are cleared for marketing without clinical testing or weighty evidence that they are safe and effective; a manufacturer simply has to show that its device is “substantially equivalent” to one that has previously been cleared — even if the earlier device was recalled by the manufacturer after safety problems.
The best approach would be for the government to fully finance the F.D.A. That is unlikely to happen. So before it ratifies any new deal on “user fees,” Congress must ensure that patient safety is the first priority.

New Zealand, medical device regulation and patient harm


Lynda Williams: Another disastrous medical experiment
5:30 AM Thursday Apr 26, 2012  New Zealand Herald (FiDA Blog bold added.)
Recent events have highlighted the fact that neither the Ministry of Health nor any other government agency has done anything about ensuring that medical devices used in New Zealand are fit for purpose, have undergone clinical trials and are safe. This despite the fact that several major scandals have made the headlines both here and internationally over the past six months.
Through the media New Zealanders have been made aware of the fact that medical devices such as breast implants, the gynaecological mesh, and hip joint replacements can avoid having to undergo clinical trials before they are marketed and sold as the best thing since sliced bread.
The latest medical device to dominate headlines around the world are two models of metal-on-metal hip joint replacements. The first of these was the DePuy hip implant; the second is the Mitch THR hip implant. The Ministry of Health and Medsafe remained quiet until confronted by several major exposes in the NZ Herald in 2011 that led to light bulbs going on in the heads of a number of New Zealanders who had had a hip replacement. But nothing appeared on the Medsafe website.
As New Zealand patients struggled to get information an article appeared in the February 2012 issue of the British Medical Journal by investigations editor Deborah Cohen. It began: Hundreds of thousands of patients around the world may have been exposed to toxic substances after being implanted with poorly regulated and potentially dangerous hip devices, a BMJ/BBC Newsnight investigation reveals this week. Despite the fact that these risks have been known and well documented for decades, patients have been kept in the dark about their participation in what has effectively been a large uncontrolled experiment.
The metal-on-metal hip replacement implants arrived on the scene in 1997. The head at the top and the lining of the cup it fits into are made of cobalt-chromium alloy rather than ceramic or polyethylene. Of course they were marketed as the latest advance in hip replacement and were specifically targeted at younger patients who needed a hip replacement that would last their life-time.
As the BMJ paper points out, multiple studies and research organisations have warned about the carcinogenic potential of metal-on-metal hips. That cobalt and chromium ions lead to genotoxic changes, (changes that are damaging to DNA and therefore capable of causing mutations or cancer), both in laboratory settings and in animals was described in scientific journals over 30 years ago.
It comes as no surprise to learn that the manufacturers were aware of the potential for genotoxicity. A DePuy internal memo from July 2005 says: In addition to inducing potential changes in immune function, there has been concern for some time that wear debris may be carcinogenic. The mechanism is not known and only 24 local malignancies have been reported in patients with joint replacements. Also worrying is the possibility of distant effects. One study suggested a threefold risk of lymphoma and leukaemia 10 years after joint replacement. The metal to metal total hip appears to be quite promising and in the laboratory the data is (sic) definitely in its favour. However, the ultimate test is the long term human experience.
Rather than advising regulators and patients of their concerns, companies tweaked the design of these devices.
The experiment continued, but only outside the USA. While the DePuy ASR products were approved by the Australian Therapeutic Goods Administration in October 2003, they were not cleared by the US Food and Drug Administration until January 2008. However, the failure rates for total hip replacements were soon found to be higher than they should be, and concerns began to be raised. In December 2009 DePuy withdrew the ASR products from both the Australian and New Zealand markets.
In August 2010 DePuy contacted Medsafe proposing to distribute a recall notice to all ASR trained surgeons in New Zealand. Medsafe did not list the recall on its website, and nor did it provide any information to patients about the problems associated with metal-on-metal hip replacements. When the Herald asked the Minister of Health about Medsafe's failure to list the ASR recall on its website when other recalls were listed, Tony Ryall replied As part of the new joint agreement with Australia, which comes into effect July 1, I would expect such recalls to be listed on the joint website. The fact that it hasn't reflects Medsafe's past practice and this will be changing.
The rebuke from the Minister was clearly enough to make Medsafe spring into immediate action. A comprehensive timeline of events and documents leading up to the recall of ASR hip replacements is now on their website. It tells a by now very familiar and extremely depressing story.
When problems began to surface with ASR hip joints and various committees in the UK met to discuss the issues, the concerns were not made public and no alert was put out to surgeons or patients. Another disturbing aspect to this was mentioned in the BMJ article which referred to the fact that there were special risks for women of child-bearing age due to the fact that metal ions had been detected in umbilical cord and placental blood.
Neither the European nor the American regulators picked up the high levels of metal ions produced by the modified hip replacement devices when they came onto the market, as there was no requirement for any post-approval studies that would follow-up patients implanted with devices capable of producing toxic debris.
The BMJ paper ended with the following conclusion: After a series of failures, device regulation is in need of radical change. For its part, the FDA has decided to place all hip implants into a high risk category fast track entry will be forbidden".
In Europe there is little doubt the current system is not fit for purpose and talks are underway about how to improve it. As Professor Freemantle asks: Why is it that people are afforded different levels of protection depending on whether they have a heart attack, diabetes, or a hip replacement in their old age? The methods of device regulation seem to be more from the 1950s than the 21st century.
Professor Freemantle's question is a very good question indeed. Because New Zealanders who have had hip replacements are unaware that they have been part of yet another disastrous experiment, it is a question that needs an answer from both the Minister of Health and the Health & Disability Commissioner.

 LINK

Friday, April 27, 2012

June 27 and 28, 2012-FDA public meeting on failed hips

UK and Australian Registries: Patient Harm   (Meeting notice and panel roster bolded by FiDA blog.)

 June 27-28, 2012: Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee Meeting Announcement
Center
Date
Time
Location
CDRH
June 27-28, 2012
8:00 a.m. - 7:00 p.m.
Meeting location is to be determined (TBD). Prior to the meeting, FDA will announce the meeting location in a future Federal Register notice.
DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration 

[Docket No. FDA-2012-N-0293]

Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA).  The meeting will be open to the public.

Name of Committee:   Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee.

General Function of the Committee:  To provide advice and recommendations to the Agency on FDA's regulatory issues.

FDA is opening a docket to allow for public comments to be submitted to the Agency on the issues before the Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee.  Submit either electronic or written comments by May 9, 2012.

Location: Meeting location is to be determined (TBD). Prior to the meeting, FDA will announce the meeting location in a future Federal Register notice. We will also provide the meeting location on FDA's Advisory Committee Information line, 1-800-741-8138 (301-443-0572 in the Washington, DC area) and on the Agency’s Web site at http://www.fda.gov/AdvisoryCommittees/Calendar/default.htm.

Contact Person:  Avena Russell, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, rm. 1535, Silver Spring, MD 20993-0002, 301-796-3805, Avena.Russell@fda.hhs.gov, or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area), and follow the prompts to the desired center or product area.  Please call the Information Line for up-to-date information on this meeting.  A notice in the Federal Register about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice.  Therefore, you should always check the Agency's Web site and call the appropriate advisory committee hot line/phone line to learn about possible modifications before coming to the meeting.

Agenda:  On June 27 and 28, 2012, the committee will discuss current knowledge about the safety and effectiveness of Metal-on-Metal (MoM) hip arthroplasty systems.  FDA is convening this committee to seek expert scientific and clinical opinion on the risks and benefits of these types of devices based on available scientific data.  

Hip arthroplasty is intended to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficiesufficient sound bone to seat and support the components.  

There are two categories of metal-on-metal hip arthroplasty systems: 

1.    Metal-on-Metal total hip replacement (THR) systems consist of a metal ball (femoral head), a metal femoral stem in the thighbone, and a metal cup in the hip bone (acetabular component).  MoM THR systems are typically indicated for use in total hip arthroplasty in skeletally mature patients with the following conditions:
a.    Non-inflammatory degenerative joint disease (NIDJD) such as osteoarthritis, avascular necrosis, post-traumatic arthritis, ankylosis, protrusio acetabuli, and painful hip dysplasia;
b.    Inflammatory degenerative joint disease such as rheumatoid arthritis;
c.    Correction of functional deformity; and,
d.    Revision procedures where other treatments or devices have failed.

2.    Metal-on-Metal hip resurfacing systems consist of a trimmed femoral head capped with a metal covering and a metal cup in the hip bone (acetabular component).  Hip resurfacing arthroplasty is intended for reduction or relief of pain and/or improved hip function in skeletally mature patients having the following conditions:
a.    Non-inflammatory degenerative arthritis such as osteoarthritis, traumatic arthritis,  avascular necrosis, or dysplasia/developmental dislocation of the hip (DDH); or 
b.    Inflammatory arthritis such as rheumatoid arthritis.

Resurfacing systems are intended for patients who, due to their relatively younger age or increased activity level, may not be suitable for traditional total hip arthroplasty due to an increased possibility of requiring ipsilateral hip joint revision.

In February 2011, FDA published a Web site on MoM total and resurfacing hip systems with information for orthopedic surgeons and for patients with or considering hip replacement (http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/Implantsand
Prosthetics/MetalonMetalHipImplants/default.htm).

Numerous recent publications, studies and registry reports have raised safety concerns for MoM THRs.  In February 2012, the United Kingdom’s (UK) Medicines and Healthcare products Regulatory Agency (MHRA) published a Medical Device Alert with updated advice on the management and monitoring of patients implanted with MoM hip systems recommending more aggressive followup of patients with larger THR systems (≥36 millimeter (mm)). Further information about actions taken by MHRA, with links to information about MoM hip implants for patients and healthcare professionals, is available on their Web site at http://www.mhra.gov.uk/Safetyinformation/Generalsafetyinformationandadvice/Product-specificinformationandadvice/Product-specificinformationandadvice%E2%80%93M%E2%80%93T/Metal-on-metalhipimplants/index.htm. (FDA has verified the Web site address, but we are not responsible for any subsequent changes to the Web site after this document publishes in the Federal Register.)

In December 2011, the American Academy of Orthopedic Surgeons (AAOS) published an overview on MoM hip systems (total and resurfacing) (Ref. 1). The AAOS overview provides a summary of clinical outcomes in patients with MoM hip systems in comparison to other bearing surface combinations, addresses patient, implant and surgical factors that may predict successful/unsuccessful outcomes of MoM hip systems and discusses the prevalence of adverse clinical problems from MoM hip systems in comparison to other bearing surface combinations.  One item referenced in the report is the Australian registry, which reported higher revision rates for patients with implants that have large-diameter heads (>28 mm) (Ref. 2). 

While current data are highly suggestive that a large percentage of patients with MoM hip systems have successful outcomes, a recent scientific publication raised serious concerns about the failure rates of MoM hip systems for the UK population (Ref. 3). This peer-reviewed journal article presented the following findings regarding primary MoM THR:  (1)  Increased failure rate at 5 years for MoM THR related to larger head sizes; (2) significantly higher risk for revision in female patients (Note:  In the United States, labeling discourages use of MoM hips in females of child bearing age with warnings in MoM THR labeling and contraindications in MoM hip resurfacing labeling); and (3) revisions for dislocation in men with MoM replacements were slightly lower, showing some benefit to larger head sizes.  

The committee will be asked to discuss the following as it pertains to these devices in the U.S. population: Device mechanisms of failure, metal ion testing, imaging methods, local and systemic complications, preoperative and postoperative patient risk factors, as well as clinical followup considerations for patients with MoM hip systems (total and resurfacing).

FDA intends to make background material available to the public no later than 2 business days before the meeting.  If FDA is unable to post the background material on its Web site prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA's Web site after the meeting.  Background material is available at http://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee link.

Procedure:  FDA will work with affected industry, professional organizations, and societies that have an interest in the MoM hip arthroplasty systems and who wish to make a presentation separate from the general open public hearing; time slots on June 28, 2012, between approximately 9 a.m. and 10 a.m. Representatives from industry, professional organizations and societies interested in making formal presentations to the committee should notify the contact person on or before May 1, 2012. 

Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee.  Written submissions may be made to the contact person on or before May 9, 2012.  On June 27, 2012 oral presentations from the public will be scheduled between approximately 9 a.m. and 10 a.m.  Those individuals interested in making formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before May 1, 2012.  Time allotted for each presentation may be limited.  If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session.  The contact person will notify interested persons regarding their request to speak by May 2, 2012. 

Comments:  FDA is opening a docket to allow for public comments to be submitted to the Agency on the issues before the Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee beginning on [INSERT DATE OF PUBLICATION IN THE FEDERAL REGISTER], and closing on May 9, 2012.  Interested persons are encouraged to use the docket to submit electronic or written comments regarding this meeting.  Submit electronic comments to http://www.regulations.gov.  Submit written comments to the Division of Dockets Management, Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD  20852.  It is only necessary to send one set of comments.  Identify comments with the docket number found in brackets in the heading of this document.  Received comments may be seen in the Divisions of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.  

Persons attending FDA's advisory committee meetings are advised that the Agency is not responsible for providing access to electrical outlets.

FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with physical disabilities or special needs. If you require special accommodations due to a disability, please contact James Clark, James.Clark@fda.hhs.gov or 301-796-5293 at least 7 days in advance of the meeting.

FDA is committed to the orderly conduct of its advisory committee meetings.  Please visit our Web site at http://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures on public conduct during advisory committee meetings.

Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2).

I.  References

The following references have been placed on display in the Division of Dockets Management (see Comments) and may be seen by interested persons between 9 a.m. and 4 p.m., Monday through Friday. (FDA has verified the Web site addresses, but FDA is not responsible for any subsequent changes to the Web site after this document publishes in the Federal Register.)

1.     American Academy of Orthopedic Surgeons, “Modern Metal-on-Metal Hip Implants:  A Technology Overview” (July 15, 2011), accessed online at http://www.aaos.org/research/overviews/Metal_On_Metal.pdf  . 

2.     Adelaide: Australian Orthopaedic Association, Australian Orthopaedic Association National Joint Replacement Registry: Annual Report 2010, 2010.

3.     Smith, A.J., P. Dieppe, K. Vernon, et al., “Failure Rates of Stemmed Metal-on-Metal Hip Replacements: Analysis of Data From the National Joint Registry of England and Wales,” Lancet, (March 13, 2012), accessed online at http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(12)60353-5/fulltext#article_upsell  (doi:10.1016/S0140-6736(12)60353-5).

Dated: March 27, 2012.

Leslie Kux,

Assistant Commissioner for Policy.


Roster of the Orthopaedic and Rehabilitation Devices 
Panel
Purpose: The Committee reviews and evaluates data concerning the safety and effectiveness of marketed and 
investigational orthopedic and rehabilitation devices and makes appropriate recommendations to the Commissioner
 of Food and Drugs.

As part of the Food and Drug Administration's (FDA's) ongoing efforts to recruit qualified experts with minimal
 conflicts of interest who are interested in serving on FDA advisory committees, FDA is requesting nominations
 for members to serve on its advisory committees.
Current Number of Vacancies: 0
Note, one or more vacancies may be in the nomination process 
or a final appointment may have been made.
Designated Federal Official
Avena Russell, ABD, MS
LT, US Public Health Service
Center for Devices and Radiological Health
Office of Device Evaluation
10903 New Hampshire Ave
WO Bldg 66, Room #1535
Silver Springs, MD 20993
Phone: 301-796-3805
Fax: 301-847-81

*Consumer RepresentativeConnie F. Whittington, MSN, RNExpertise: Adult Health Nursing
Term: 6/11/2010 – 8/31/2013
Vice President of Patient Services
Piedmont Hospital
1968 Peachtree Road, NW
Atlanta, GA 30309


Chairperson
John D. Kelly, IV, M.D.
Expertise: Orthopaedic Surgery
Term: 02/19/2010 – 08/31/2013
Associate Professor, Orthopedic Surgery
Hospital of the Univ. of Pennsylvania
Penn Sports Medicine Center

235 S 33rd St.
Philadelphia, PA 19140

Brent A. Blumenstein, Ph.D.Expertise: Biostatistics
Term: 09/15/2010 – 08/31/2014
Principal Consultant
Trial Architecture Consulting
Washington, DC 20008
**Industry Representative Robert E. Durgin
Expertise: Regulatory and Clinical Affairs
Term: 10/29/08 - 8/31/12
Sr. Vice President, Quality/Regulatory/Clinical Affairs
Biomet, Inc.
56 East Bell Drive
Warsaw, IN 46582
John F. Kragh, Jr., M.D.Expertise: Orthopaedic Surgery
Term: 02/19/2010 – 08/31/2012
US Army Institute of Surgical Research
Attn: MCMR-USZ
3851 Roger Brooke Dr. Bldg 3611 Room 282-4
Ft. Sam Houston, TX 78234-6315
David R. McAllister, M.D.Expertise: Orthopaedic Surgery; Sports Medicine
Term: 02/19/2010 – 08/31/2012
Chief of Sports Medicine Service
David Geffen School of Medicine at UCLA
Dept. of Orthopaedic Surgery
Center for Health Sciences -Box 956902
Los Angeles, CA 90095-6902
Hollis G. Potter, M.D.Expertise: MRI Assessment of Cartilage
Term: 02/19/2010 – 08/31/2013
Chief, MRI Radiology and Imaging
Hospital for Special Surgery
535 East 70th Street Main-BM06
New York, NY 10021
Raj D. Rao, M.D.Expertise: Orthopaedic Surgery
Term: 02/19/2010 – 08/31/2013
Professor and Dir., of the Div., of Spine Surgery
Dept. of Orthopaedic Surgery
Medical College of Wisconsin
9200 W. Wisconsin Ave.
Milwaukee, WI 53226-0099
William L. Rohr, M.D.
Expertise: Orthopedics
Term: 09/15/2010 – 08/31/2014
Surgeon
510 Cypress L. Street
Fort Bragg, CA 95437