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.

National Joint Replacement Registry

Adverse Effects

Countries like Sweden and New Zealand have stellar national registries that track most joint replacement surgeries performed in their countries. Such registries prevent faulty devices from entering their quality control system and helps minimize revision surgeries. Unfortunately, the lack of a National data registry in the United States has resulted in the rampant use of defective artificial joints. Some registries do exist like the American Joint Replacement Registry and the Kaiser Permanente National Total Joint Replacement Registry. Such registries lack a uniform system to collect, share, or require hospital participation in these registries. Currently patients face a greater risk of revision surgery without a quality control system in place.
Recent joint implant recalls in the United States have caused panic among patients. Some of these faulty devices are known to be fatal among patients that require a revision surgery. The absence of a nationalized registry has resulted in some patients learning of faulty implants from their attorneys instead of their doctors. Most patients experience excruciating pain and have difficulty finding the right doctor to make the proper diagnosis. The ‘National Hip and Knee Replacement Registry Act of 2009” was introduced in the House of Representatives, but failed to pass legislation.

National Joint Replacement Petition

National Joint Replacement Petition

Caring Hearts USA has generated a petition for Congress to introduce a bill to create a ‘National Joint Replacement Registry’ and pass legislation. Private John Doe has already had nine costly surgeries. He faces having another major surgery but cannot afford the costs.
A revision surgery is needed because the stem of the implant is loosening and extremely painful for our veteran. We must rid the system of faulty devices that put patient lives at risk. Taking the necessary action now can help spare other families from suffering the pain and hardship.
Please sign our petition NOW so Americans can have a quality control system. Perhaps purchase a shirt from our store to show your support and help spread the word. Like us on facebook so you can follow us and get more details about the surgeries.