Hip Resurfacing News

For Immediate Release: October 13, 2010 Media Inquiries: Karen Riley, 301-796-4674, karen.riley@fda.hhs.gov Consumer Inquiries: 888-INFO-FDA

   FDA: Possible increased risk of thigh bone fracture with bisphosphonates Labeling change adds warning about possible risks of long-term use of osteoporosis drugs  

The U.S. Food and Drug Administration today warned patients and health care providers about the possible risk of atypical thigh bone (femoral) fracture in patients who take bisphosphonates, a class of drugs used to prevent and treat osteoporosis. A labeling change and Medication Guide will reflect this risk.

Bisphosphonates inhibit the loss of bone mass in people with osteoporosis. Bisphosphonates have been shown to reduce the rate of osteoporotic fractures -- fractures that can result in pain, hospitalization, and surgery-- in people with osteoporosis. While it is not clear whether bisphosphonates are the cause, atypical femur fractures, a rare but serious type of thigh bone fracture, have been predominantly reported in patients taking bisphosphonates. The optimal duration of bisphosphonate use for osteoporosis is unknown, and the FDA is highlighting this uncertainty because these fractures may be related to use of bisphosphonates for longer than five years.

The labeling changes and Medication Guide will affect only those bisphosphonates approved for osteoporosis, including oral bisphosphonates such as Fosamax, Fosamax Plus D, Actonel, Actonel with Calcium, Boniva, Atelvia, and their generic products, as well as injectable bisphosphonates such as Reclast and Boniva.

Labeling changes and the Medication Guide will not apply to bisphosphonates used for Paget's disease or cancer/hypercalcemia such as Didronel, Zometa, Skelid, and their generic products.

"The FDA is continuing to evaluate data about the safety and effectiveness of bisphosphonates when used long-term for osteoporosis treatment," said RADM Sandra Kweder, M.D., deputy director, Office of New Drugs in the FDA's Center for Drug Evaluation and Research. "In the interim, it's important for patients and health care professionals to have all the safety information available when determining the best course of treatment for osteoporosis."

Today's warning follows a March 10, 2010, Drug Safety Communication announcing the FDA's ongoing safety review of bisphosphonate use and the occurrence of atypical femur fractures. The FDA has since reviewed all available data on bisphosphonate use, including data summarized in the American Society for Bone Mineral Research Task Force report. The report recommended additional product labeling, better identification and tracking of patients experiencing these breaks, and more research to determine whether and how these drugs cause the serious but uncommon fractures.

Based on the FDA's review, the Warnings and Precautions section of all bisphosphonate products for osteoporosis will be revised, and the FDA will require the inclusion of a Medication Guide to better inform patients of the possible increased fracture risk.

The FDA recommends that health care professionals be aware of the possible risk in patients taking bisphosphonates and consider periodic reevaluation of the need for continued bisphosphonate therapy for patients who have been on bisphosphonates for longer than five years.

Patients taking bisphosphonates for osteoporosis should not stop using their medication unless told to do so by their health care professional. Those taking bisphosphonates also should report any new thigh or groin pain to their health care provider and be evaluated for a possible femur fracture. Patients and health care professionals should report side effects with the use of bisphosphonates to the FDA's MedWatch Adverse Event Reporting program at www.fda.gov/MedWatch or by calling (800) 332-1088.

For more information: FDA Drug Safety Communication Consumer Update: Possible Fracture Risk With Osteoporosis Drugs

A member of my Hip Talk Discussion Group http://www.surfacehippy.info/hiptalk/ asked why it took surgeons so long to learn how important the angle of the acetabular cup angle is during hip resurfacing surgery. Incorrect placement of the acetabular cup has caused many failures of hip resurfacing resulting in revisions to total hip replacements.

My answer to that questions of why it takes so long to learn if a hip device and/or surgical technique is successful is if anyone has worked in the engineering or design field, they will realize that usually the original design of a product or machine is never what the final design turns out to be. We are not machines that can determine perfect designs for anything. There are always unknowns. If you think about many things in our lives, they are always under constant change and updates. Car models are often changing, TVs are changing, cell phones, computers, etc. are constantly in change. Software for computers are always updating and changing. Athletes are always changing techniques to improve their skills. Musicians are always practicing to improve their skills. Medicine and joint replacement is not any different. Engineers are trying to design a device to replace a human joint while doctors are trying to place that foreign object in our bodies to act as the original equipment. This is not an easy task. There have been thousands of designs of hip devices over the years. The metals or plastics continue to change, the metallurgy changes, and the designs of the components change. There is nothing static about designs, they are constantly changing.

I learned from the many hip resurfacing conferences I attended, that it takes time for doctors to learn how the devices are actually working in patients. Typically it takes about 3 to 4 years for them to start to see trends about how the device has acted and how the bone growth has attached to the components. It takes time for the results to become statistics. So with any device, the wait period takes time and often by then, there has been a change in the device. So there are few devices of the same design left after a few years to compare results.

It simply is very difficult tracking the new devices and their results right after their implant. Many of the top experienced surgeons were placing the actabular cups at a good angle early on. They knew instinctively that the acetabular cup should be in a certain position to work well. I have always said and heard surgeons say the same thing, that surgical skill is more than a skill or learned process, it is also an art. It is like the great athletes that instinctively know what to do. They do learn and practice, but have a God given skill that places them way above many other athletes. The same is true with the really top surgeons. If you think about sports or activities you are personally really good at, you are not looking at the educational videos or books to learn how to throw a ball, play an instrument or type on a computer. Those with really good skills are able to do it almost without thinking. That's is the way it is with the top surgeons. They had an instinct about how things should work and were very successful. McMinn of the UK is doing that all the time as he develops devices. Many of the other top surgeons have helped develop hip devices and many of the surgical instruments to help place hip devices. A recent example of one is with Dr. Kusuma in Columbus. http://www.surfacehippy.info/observinglivesurgery.php  He wanted a better way to insure his placement of a BHR was correct. He developed a template system which no other surgeon had done before. Smith & Nephew are thinking of having him teach it to new surgeons.

There is a great deal of constant change with any hip device or any man made mechanical device. Designs keep changing and hopefully for the better. Skills and instruments to place joint devices keep changing and hopefully for the better. It is very complex and just takes time to develop excellent devices and how to place them exactly. The orthopedic surgeons keep track of their series of hip resurfacings and the National Directories  http://www.surfacehippy.info/nationalregistries.php keep track of hip resurfacing patients.  It takes time for all the statistics and results to accumulate and become tools to help learn about a hip device and a specific surgical technique.

Pat

I wanted to take the time out to thank you so much for your informative web site.

A year ago, I was diagnosed with Osteoarthritis and was told that I needed a THR. Well, as a young 45 active male use to being active until the pain took over, I scheduled the THR.

However, when I started researching I came across your site www.surfacehippy.info . That is when I found Dr. Mont in Baltimore, a 2 hr drive up the road. Needless to say, I did my due diligence and watched all of the interview videos and read numerous patient stories. All from your site.

Well, after going through Dr. Mont’s physical therapy program, I made the decision that my osteoarthritis was progressing for the worse and that surgery was needed. So in late August, the surgery was done.

I am happy to report that the day after surgery I took no pain meds. Simply stated, the pain prior to surgery far exceeded the surgical pain. More important, after my 5 week appointment at Dr. Mont’s office, I was cleared for Physical Therapy. It was 3 weeks after the therapy that I was back in the woods bow hunting.

I thank you for your efforts and will keep up with your site for new and breaking progress in this field of study.

Respectfully,

Dale Weaver