Warranty on hips, knees: Consumers Union petition needs your signature!

Guarantee that knee, fix that hip!

The most important (and expensive) product you may ever buy doesn't come with a warranty. It's time we change that.

Medical device manufacturers are making billions by selling knee and hip implants to Americans who want to feel better and play longer. But when these devices fail, patients – as well as taxpayers – are faced with costly bills to replace them.

Manufacturers claim implants are safe and of high quality. If that's true, why aren't all the major companies (only Biomet warranties one of its knee products) backing up these implants when they fail? 

Consumers Union has sent the top six hip and knee makers details of what should be in a strong 20-year warranty, and asked them to comply. Sendyour own message now, and let's make sure manufacturers – notpatients – are on the hook when products fail!

Artificial hips and knees need a lemon law, says Consumer Reports

By Joel Keehn   FiDA highlight

Published September 10, 2013

Consumer Reports  On Twitter:  @ConsumersUnion and @CUsafepatient

Imagine if you had to take a new car back to the dealer to get a defective part fixed and you, not the manufacturer, had to pay for the work. Well, that’s the situation with artificial knees and hips.

Nearly 20 percent of the hip replacements done each year and 10 percent of the knee replacements are revisions, often done because the original device was defective. Those follow-up surgeries tend to require longer hospital stays than the initial procedures, pose additional risks, and have a higher price tag, too. Yet their costs are passed onto consumers or their insurance companies, including Medicare.

That’s one of the reasons Consumers Union, the policy arm of Consumer Reports, says manufacturers of hip and knee implants should give patients warranties, guaranteeing to replace defective devices at no cost. That, they say, is not only fairer to patients, but might encourage companies to make their devices safer and more durable.

“While patients may be told by their surgeon how long a device can be expected to last, they rarely get a guarantee in writing since most hip and knee implants do not come with a warranty,” said Lisa McGiffert, director of Consumers Union’s Safe Patient Project.

The SafePatientProject recently gathered information from the Food and Drug Administration on hip and knee implant recalls over the past 10 years, and found that all major manufacturers had recalled a product or line of products. And some of those recalls involved products that posed real risks.

See our surgery Ratings for hip and knee replacement as well as our advice on smarter hip and knee repair. Our hospital Ratings offer detailed information on more than 4,000 hospitals nationwide. 

For example, since 2003 about 750,000 Americans received metal-on-metal hips, which were supposed to last longer than devices made with ceramic and plastic. Not only were such hips more likely to fail, but also some patients experienced debilitating symptoms from metal debris that flakes off the device over time, including heart damage and neurological problems.

Knee implants have not failed as often or as dangerously, but the Safe Patient analysis found that hundreds of knee-implant components have been recalled since 2003, often because they were shipped with the wrong part, a wrong size part, a missing part, or a part built for the left side etched as a right, or vice versa.

As our earlier report on dangerous medical devices found, most hip and knee implants are allowed on the market without being reviewed for safety and effectiveness by the FDA. Instead, under current law, the companies simply have to demonstrate that the devices are “substantially equivalent” to a product already being sold. Since most new hip and knee implants are similar to ones already on the market, manufacturers can gain approval through the FDA’s fast track 510(k) clearance process without having to prove the device is safe and effective.

“Medical device companies claim that current law provides adequate protection for patients and that their implants are dependable and safe,” said McGiffert. “If that’s the case, they should have no objection to offering warranties to back up those claims. Patients and taxpayers shouldn’t be on the hook for the cost of replacing devices when they fail.”

The Safe Patient has urged the makers of hip and knee implants, including Biomet, Inc., DePuy Synthes, Smith & Nephew, Stryker Corporation, Wright Medical Technology, Inc., and Zimmer Holdings Inc., to provide a 20-year warranty that:

covers the full cost of the revision surgery, including the device itself, the surgeon and hospital costs, and patient out-of-pocket costs;

establishes a clear system for patients to use, including a toll-free phone line and a registration number to track the claims process, with physicians charging the device company, not the patient; and

does not eliminate the patient’s right to sue if he or she uses a warranty.

 Read more: http://www.folemon-law-says-consumer-reports/#ixzz2eWAG8ba3

In addition, you can contact 
Patrick.Conway@cms.hhs.gov (Chief Medical Officer) 
shari.ling@cms.hhs.gov (Deputy Chief Medical Director) 
Lead purchasing decision-makers in the U.S. who need to know from each of you that implanted medical devices are poorly vetted globally, they harm people permanently, the harm is preventable and patients are not given informed consent.

Howard Sadwin: Video of Medical and Legal Purgatory

Howard Sadwin, too late, sees clearly the trap that he entered when he got his second failed hip.  He has researched the ecosystem of toxic lies & misinformation that are told by medical device sales reps, hospital administrators, FDA regulators and even elected officials.  He traveled to Washington DC June 27 and 28, 2012 to testify and share this information with the public.

http://www.fda.gov/AdvisoryCommittees/Calendar/ucm306172.htm

See Howard's Testimony at 1:52:52

 According to Howard, no journalist has yet to go beyond hip trial or personal stories.  It is time to tell the full story to protect our nations' healthcare funding.  Allowing failed devices to compete directly with functioning devices exposes patients to devastating harm.

Pre-emption laws are not events mentioned nor understood.  The media can help expose this flaw.

The FDA was created for our safety and well being yet the pre-emption laws protect PMA approved devices.  The pre-emption laws were to prevent patients from suing manufacturers for every little issue.  They were not created to harbour a manufacturer from prosecution when their device malfunctions, hurting thousands.   (Such as Smith&Nephew’s Birmingham Hip Resurfacing device (Bhr). ) The 5^th amendment gives us the right to Due Process, part of the Bill of Rights protets against abuse of government authority in legal procedure.  

Harmed Patient asks PCORI to Fund Research on Implants

This letter was emailed to Susan E. Sheridan, Director of Patient Engagement, PCORI Patient Centered Outcomes Research Institute, www.pcori.org ssheridan@pcori.org 10/29/12

Dear Susan,

Joleen Chambers has asked me to send information to help enlighten your knowledge as to failed implants. On June 27-28^th, 2012 I traveled to Washington, DC to speak to the FDA re: metal hips.

I was proud to participate in this function, hoping some good may come from the meeting. However, the FDA heard testimonies from other victims of metal hip nightmares and they heard from renown scientist, surgeons and doctors from our country that they saw no need to use metal on metal hip devices as they have recently proven to cause more harm than good. The FDA has been gathering information on this matter for years

Yet market share and rate of returns seem to dictate what actions are or are not taken regarding these devices. The apparent ongoing corruption is sickening.

If the Church, the auto and oil industries, Penn State, now the Boy Scouts are all held accountable for their miss deeds or malfunctions how does a medical device get a free pass when it causes harm to more people than the acceptable failure rate.

I had a Smith & Nephew Birmingham hip resurfacing device implanted in 2007, after my 3^rd dislocation the device was removed in 2010 leaving me in the  hospital fighting for my life for 11 months, 12+ surgeries etc.

I was an active 61 old, played sports, great work, great grandchildren and family, friends etc all of these great things have been altered for the rest of my life. Today I am in a wheelchair, I can no longer do the things I enjoyed the most in life, playing with the kids, hunting, fishing my personal life with my wife has been destroyed. The list goes on and on.

 I have become an advocate in as much I am searching for answers as to why this happened, how it happened and what can I do to see it never happens again based on present day circumstances.

I have helped folks through the internet, letting them know they aren’t alone in this nightmare, I have actually got a few victims into see a specialist in orthopaedic hip problems when other surgeons refused to help.

If you are so inclined please read the FDA notes on the meeting held in DC on September 8, 2005 regarding the approval of the Smith & Nephew hip (BHR) The sole patient test group was controlled by one of the inventors of the bhr, these patients were cherry picked all from the abroad, no test done in the USA, this individual received 66 million pounds for his company ( the highest gross income reported by this company Midland Medical Tech was 23 million pounds—so how is it worth 66 million—then the individual received an additional 33 million pounds once the bhr was pma (pre-marketing approved) by the FDA—Conflict of interest???

The minutes of this meeting clearly state enough unkown answers and it expressed enough concerns on the bhr that it never should have been approved, yet it passed by a 3/2 vote.

Wright medical submitted a letter asking for this device’s approval to be denied as it had conflicting materials of the rules and regulations stated by the FDA, so how did it get approved –CORRUPTION.

To make matters worse because the bhr was pma approved it is now protected by the pre-emption laws. Basically they get to hurt me (others) and there is little I can do about it.

I have accumulated enough information and material on this matter to write a book, however what I want is accountability from the manufacturer for me and the 1000’s of others the device has hurt.

I think this is enough to get you started, I am available and willing to do whatever I can to see justice is served and those that need help will receive it.

You can reach me hbs924@verizon.net  or my cell is 941-928-29

Consumers Union on Capitol Hill: Real People

Consumers Union

Real People, Real Medical Device Stories:

It’s Time To Include Devices in the FDA’s Sentinel Initiative To Identify Early and Ongoing Problems That Cause Harm

“A few weeks after my elbow prosthesis was surgically implanted, during movement it would make a popping or creaking sound. Four months later, the elbow was blue green and I was in extreme pain. I am now in medical and legal purgatory.”– Steven Baker, Bloomington, MN  

In May 2008, Steven Baker, a proud Air Force veteran and father of two middle school children, had an elbow replacement surgery hoping to regain function and eliminate pain from his right arm that had been damaged in a 2001 work accident. But the implant failed after just four months.

Steven had to undergo “revision” surgery to address the device failure but his extreme pain has persisted and his elbow joint now locks up unpredictably. Steven's health was severely compromised by the revision surgery. He takes maximum dose, long term prescription medication to help mitigate the pain. The pain medication has caused his teeth to rot because of "dry mouth" making eating and talking difficult. And Steven may never be able to get his elbow fixed.

A few thousand elbow replacement surgeries are done each year in the U.S. Patients like Steven with elbow implants require close monitoring and face the prospect of needing to have them surgically removed. Design flaws can cause poor function and other complications for patients, such as dislocation of the device following surgery, joint stiffness and the need for additional surgeries.

Consumers Union urges Congress to adopt the Senate provision of the FDA User Fee Act that includes medical devices in the Sentinel Initiative. Both House and Senate versions of the bill include devices in this important post-market surveillance program. However, the House removes current law that requires the Secretary to use critical information from adverse event reports from people like Steven in the agency’s post-market risk identification and analysis system. We believe this information is critical for monitoring problems with devices on the market and should remain in the law.

For information contact Lisa McGiffert at lmcgiffert@consumer.org