510 (K) APPROVAL PROCESS

As recently as 2010, it was estimated that as many as one-third of the 250,000 hip replacement surgeries performed each year in the U.S. involved the use of metal-on-metal hip replacements. Such devices were marketed to younger, more active patients, and it was believed that they would prove to be more durable than hip implants constructed of other materials.

However, the U.S. Food & Drug Administration (FDA) allowed metal-on-metal hip replacements to come to market under its 510(k) approval process, which doesn’t require any human testing for medical devices that are shown to be “substantially equivalent” in design to a product already approved by the agency. Unfortunately, this type of FDA clearance means that any problems with a medical device are not usually detected until it has been used in hundreds, if not thousands, of patients.

DePuy Pinnacle Lawsuits Increase

The numbers of DePuy Pinnacle lawsuits continue to grow in the federal litigation established in the Northern District of Texas. Over 5,700 DePuy Pinnacle hip lawsuits have been filed in the proceedings on behalf of individuals who have been seriously injured by these implants, allegedly due to the metal-on-metal version of DePuy Orthopaedics’ Pinnacle Hip Replacement System. Court documents indicate that the number of filings have increased by more than 150 since the Court issued its previous update in late January 2014.

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.

MEDICAL GROUPS ISSUE CONSENSUS STATEMENT

Several medical groups, including the American Association of Hip and Knee Surgeons, the American Academy of Orthopaedic Surgeons, and The Hip Society, have issued a Consensus Statement regarding the management of patients with metal-on-metal (MoM) hip implants. The purpose of their statement is to inform and educate patients, and the public at large, about the issues surrounding metal-on-metal hip replacements.

A vast majority of patients who have hip replacements have experienced positive results and are quite pleased with their surgical outcome, but some hip replacements fail. Hip replacements can fail because of various reasons, such as the implants become loose in the bone, the hip comes out of the socket (dislocation), the joint becoming infected and the surface of the joint replacement wears out. The debris generated by wear of the joint replacement can damage the surrounding bone and soft tissues (muscles, tendons, ligaments, and hip capsule).

Some recent scientific studies have reported a higher than expected failure rate of metal-on-metal hip replacement design. Although the exact number of MoM hip replacements performed to date in the United States is unknown, nearly 40,000 all-metal hip replacements were performed during a 12-month period from 2005 to 2006 in the United States. An estimated 32% of all hip replacements were allegedly performed in the country during that timeframe.

It is worth noting that adverse periprosthetic tissue reactions involving the hip joint have emerged as an important reason for metal-on-metal hip implant failure. The Consensus Statement was published jointly in the January issue of the Journal of Bone and Joint Surgery. The findings pertaining to failure rates and adverse tissue reactions associated with metal-on-metal hips noted in the Consensus Statement is consistent with the allegations put forth in DePuy Pinnacle lawsuits.

HAPPY NEW YEAR

Caring Hearts USA would like to wish everyone a Happy New Year! We wish this New Year would fill your life with warmth, joy and beauty. We hope “2014” brings you unlimited smiles and happiness and the best of everything.

“Your success and happiness lies in you. RESOLVE to keep happy, and your joy and you shall form an invincible host against difficulties.” Helen Keller

MERRY CHRISTMAS

Welcome to “Caring Hearts USA.” It is that time of year when we get to take time in our busy lives to once again look at the meaning we celebrate Christmas. “And she shall bring forth a son, thou shalt call his name JESUS; for he shall save his people from their sins,” Matthew 1:21.

We hope you and your family enjoy this holiday season. We send you our best wishes for the year ahead and wish you a Merry Christmas and a Happy New Year. Thank you for your continued interest in our dedicated cause. Please feel free to share our story with your family and friends.

Happy Thanksgiving

We all have our list of things for which we are thankful for and would like to express our gratitude this holiday season. We are thankful for you and what you bring to our lives. This Thanksgiving, we will come together with family and friends to give thanks for the many blessings.

Once again, we take a moment to thank our friends and family. In this season of gratitude, our thoughts turn to those of you who have continued to put your trust in us. May you enjoy beautiful moments and be surrounded by happy memories over the Thanksgiving holiday. Please remember those still serving in our military and their families over the holidays. We extend our warmest wishes to you and your family and wish everyone a “Happy Thanksgiving” with safe travels.

HAPPY VETERANS DAY

Today we honor the brave men and women who had the courage and wore the uniform to serve our great nation. Veterans Day is frequently a day filled with mixed emotions, but a lot of happiness for those who were brave enough to answer the call. Today, take a moment out of your busy schedule to say “Thank You” to the veterans in your life, and not just forget about them tomorrow. This is an opportune time for veterans to not only reflect on their time of service, but to share stories so that future generations truly understand the sacrifices made for our country. We need to ensure our brave men and women know that we support them every day and not just on Veterans Day. May God Bless, God Speed, and Hurry Home!

Veteran Disgusted with the FDA

Like other seriously injured hip recipient patients, our veteran is clearly disgusted with the FDA. The FDA was slow to issue a safety alert concerning metal-on-metal hip implants. Metal hip implants, as a class of medical devices, have been linked to high failure rates. Most metal-on-metal hip implants have been recalled, and are now subject to litigation.

Thousands of patients have been implanted with metal-on-metal hip replacement systems and experienced a number of adverse events after surgery. These include: hip dislocation, joint infection, bone fracture, device loosening, bone loss, difference in the functional gait, and local nerve damage with numbness or weakness.

There are symptoms people should be aware of three or more months following surgery. These symptoms include: pain in the groin area, hip, or leg, swelling at or near the joint, noise (popping, clunking, grinding, or squeaking), and a limp or changing in the walking pattern.

Hip recipients with questionable symptoms may need to consult a number of doctors in order to find a doctor with adequate skills to make a proper diagnosis. Hip implant recipients are encouraged to consult others doctors if symptoms continue and the doctor cannot provide a reasonable explanation for your symptoms. Many patients suffer unnecessarily for months, if not years, before finding a doctor with the technical expertise.

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.