Metal-on-Metal Hip Implants Pulled From Market

Metal-on-metal hip replacements have recently been associated with serious side effects, including a significantly higher than expected rate of failure compared to other hip implants. The metal-on-metal design may also leak toxic chemicals into the body, increasing a hip recipient’s risk of metal poisoning and hip implant failure. An estimated 500,00 Americans have metal-on-metal hip implants, but many have no clue that they could be at risk of a severe side effect.

High failure rates and toxicity concerns have prompted the U.K. to ban metal-on-metal hip implants in hip replacement surgeries performed at National Health Service (NHS) hospitals. The NHS is the publicly funded health care system in the U.K.

The National Institute for Health and Care Excellence (NICE), issued the guidance to hospitals following alarming results from a recent study, according to The Telegraph.

The study of 17,000 patients with the devices found that some of the metal-on-metal brands had failure rates as high as 43 percent. Not only do early failures require patients to get follow-up hip replacement surgeries, called revisions, but health care professionals worry the metal hips may release toxic particles into the bloodstream.

New Warnings Issued for Smith & Nephew Birmingham Hip Resurfacing (BHR)

Smith & Nephew has issued a safety alert for its Birmingham Hip Resurfacing (BHR) system. Smith & Nephew issued a notice updating the instruction for use (IFU), after the manufacturer confirmed certain population sub-groups have been identified to be at risk of adverse outcomes if fitted with the product.

The urgent field safety notice (FSN) from Smith & Nephew revealed that women patients, men aged 65 or above and patients requiring an implant size of less than 48mm are at greater risk of requiring revision surgery earlier than expected.

It has been confirmed that the IFU changes are applicable to specific catalog numbers of the BHR Resurfacing Head, BHR Acetabular Cup and the BHR Dysplasia Cup, with more detail being available on the Smith & Nephew website. However, the website currently does not provide any information about the urgent field safety notice.

Kevin Timms, a lawyer at Irwin Mitchell’s London office who specializes in providing support to victims of faulty medical products, said: ” The new guidance issued by Smith & Nephew is a welcome step towards preventing certain sub-groups of patients from being at an earlier-than-expected risk of revision.”

“However, it also raises concerns regarding the number of patients who fall into those categories and may have already been fitted with the affected devices. As such, it is vital that the manufacturer works quickly to provide more information regarding the issues, as well as providing an explanation as to why a recall has still not been issued for small BHR implants and why the instructions for use were not updated in 2012 when a revision rate of 11.76% was confirmed in women with a 42mm femoral component. The delay is clearly unacceptable.”

“An issue of this nature is just the latest in a long line to raise concerns regarding the safety of hip replacement devices and many patients will be concerned to see these further concerns being raised.”

“Patients put great faith and trust in the fact that the devices they are being fitted with are safe for use and meet the required standards. An issue of this nature once again calls into question how specific devices are able to make it to market and whether the regulatory system in place is fit for purpose.”

“Every effort must be made to always put patient safety first and it is clear that there are many questions to be answered regarding these issues.”

SUPPLIER CHANGE

We have recently made a difficult decision to close our store as we change suppliers. We feel that God is leading us in another direction. We believe our supplier should be veteran-owned to better suit our needs. This is not a decision made lightly, and we certainly appreciate all your prayers and support, and earnestly desire your prayers right now. We want to fulfill our mission, and we need wisdom for all the decisions involved in this transition.

God has been very good to us. We are one step closer to securing our veteran’s home from foreclosure. This is truly a gift from above considering our veteran is also recovering from revision hip surgery. The additional stress is definitely something he does not need at this point. Please pray for God’s healing and wisdom concerning the upcoming decisions we need to make during this transition.

Long Road to Recovery

Doctors advised our veteran that he was headed down a long road to recovery following revision. Our veteran had 38 staples removed from the incision two weeks after revision surgery. We are thankful the incision was much smaller than originally anticipated by the surgeons. Doctors continue to take necessary precautions to ensure a favorable outcome.

After hip resurfacing surgery, symptoms surfaced that perhaps indicated something was not right with the metal-on-metal hip implant. Complaints of constant pain surfaced almost immediately after surgery. The doctor said to give the hip resurfacing time to heal. Weeks went by before weeks turned into months, and then months turned into years. The pain gradually intensified and interfered with all daily activities.

Revision surgery was required after 3 plus years of excruciating pain from the initial hip resurfacing procedure. Not even close to the 25 to 30 years of quality life promised by the manufacturer. Lawmakers, device makers, and the FDA should take a closer look at the devastation caused by these medical devices given approval without requiring any clinical testing. The FDA has since recommended changes to its policy, but does little to help those seriously injured by metal-on-metal hip implants.

BREAKING NEWS: OUR VETERAN’S HIP REVISION SURGERY

We are in the process of getting things packed and preparing to make the long trip to the Mayo Clinic. We will have a full day of testing in preparation for hip revision surgery in the coming days. However, we want to thank all of those that have been very loyal and supportive along the way. For those that have gone through this process, you already know the pain associated with the metal-on-metal implants all too well.

No doubt we will be making our dreaded journey and counting down the days. The pain is already so intense that our veteran’s pain medication has been doubled to help control the pain. Watching a loved one go through such excruciating pain is mind-boggling and outrageous to think this is the best healthcare system in the world. Again, the Veteran Administration has repeatedly denied another seriously injured veteran benefits that were rightfully earned from an alleged service-connected disability. Please keep our veteran in your prayers.

WI Disabled Veteran Request for Congressional Hearing

A disabled veteran from Wisconsin has sent a letter to Congressman Reid Ribble requesting a Congressional Hearing before Congress over concerns of regulatory malfeasance at the FDA that led to the metal-on-metal hip replacement debacle. Metal hip devices were allowed to remain on the market without medical providers having any guidelines on how to monitor 500,000 Americans for the periprosthetic and systemic complications of chrome-cobalt metallosis.

The disabled vet received a metal-on-metal hip implant in 2010, and complained of groin pain almost immediately after being implanted with the premarket approval (PMA) hip implant. It is devastating to think that the FDA was formed to protect and ensure the quality of our lives. Yet, the FDA has granted manufacturers of premarket approval medical devices full immunity from patient lawsuits. These same medical devices were not required to undergo any clinical testing.

FDA’s Premarket Approval (PMA) Medical Devices

According to an article written by Cal Warriner, most Americans are unaware that anywhere from 75 to 90 percent of medical devices pass through the 510(k) gate to approval in the U.S. and these are the same devices that are failing in England, Australia and worldwide, as those countries often follow the U.S. lead to approval.

Warriner notes only three metal-on-metal resurfacing hip implants went through the FDA’s premarket approval (PMA) process and were required to provide clinical data to prove safety before they were approved in the U.S. The Birmingham Hip Resurfacing was finally approved in the U.S. in 2006 after initially being denied. It joins the Conserve Plus by Wright Medical, approved by the FDA after a PMA in 2009, and the Cormet by Corin in 2007 – all resurfacing devices.

Unfortunately for the patients who discover after the fact that they are experiencing complications with these PMA devices, they cannot hold the manufacturer accountable due to a U.S. Supreme Court Decision, Riegel v. Medtronics, which gave medical device manufacturers immunity in court if their product received FDA approval.

FDA Regulating Medical Devices

The FDA began regulating medical devices in 1976, but did not have a classification for certain medical devices like hip replacements at the time. Therefore, they implemented a temporary solution by allowing device makers to release new medical devices on the market if they can prove that a similar device is already on the market.

It quickly became apparent with the first of many trials filed that the manufacturer knew about the serious flaws and chose to leave the medical devices on the market anyway. The exact number of patients affected by the medical implants is unknown because the United States does not keep track of such data. Instead, the U.S. relies on registries from other countries to share results.

Importance of Gait

Why do patients need to understand the importance of gait in regards to the human body? This may seem like a simple question but difficult to answer if you have an underlying medical condition not yet diagnosed by a doctor. Sometime a patient may experience a deviation of the normal gait pattern more commonly known as a limp. The initial contact of the heel is where the gait pattern begins and continues through the shifting of weight from the foot to the toes, where the weight is further transferred to the opposite leg in efforts to move the other leg forward to take a step. Thus, a limp can occur with the inability to establish full weight bearing on one leg caused by pain symptoms or structural problems of foot, ankle, and hips or back.

Pain may be an obvious indicator of a problem or injury. By limping, your body modifies its movement or weight bearing in response to your pain or structural problems. A gait standard has not been established because no two people share the same walking pattern. Doctors merely rely more on personal observation to determine if the patient has an irregular gait pattern. Rare medical conditions pose significant challenges when multiple doctors are trying to pinpoint the cause of the pain and share difference of opinions. Patients may have multiple surgeries before finding the right specialist to identify and diagnose the cause.

People sustain injuries from accidents every day, which can leave one leg being shorter than the other. Often a wedge is inserted into a shoe to compensate for the leg length. In some cases, both legs can be the same length but the person walks with a limp caused by an underlying medical condition.

Gait is not about being able to put one foot in front of the other, but merely a variety of systems and body parts that can exert force and move collectively in harmony. In rare cases, a bacterial infection in the leg or foot can be indicative of a neurological problem like nerve damage, neuromuscular disease, an injury of the spine or brain tumor. If you have a limp that continues after five days, then you should seek immediate medical attention. Ignoring the limp is the worst thing a patient can do if they have a serious underlying medical condition.

Questions and Answers

How long has Private John Doe been dealing with his pain?

Private John Doe started having pain in 2007. His pain came on gradually and got worst over time.

How did Private John Doe respond after being denied his veteran benefits?

Like any other veteran, he is frustrated and does not fully understand the reason for his denial based on all the medical records to date.

How did Private John Doe find reputable doctors?

Research and word of mouth are recommended resources for finding reputable doctors. Often doctors are prohibited from referring patients outside of their own network so you will need to do your homework to find a skilled doctor that can help you. Registered nurses offer excellent recommendations for patients and patients of the physicians are another good referral source. Today we have the internet so other patients with similar symptoms can ask questions and compare results.

Has Private John Doe ever had reputable doctors that did not share the same opinion?

Absolutely because the medical field is highly competitive and choosing the right doctor means selecting a skilled physician that has the patient’s best interest at heart.