Smith & Nephew Birmingham Metal-on-Metal Hip Opposed Before Approval
According to recently revealed information, Wright Medical tried to stop the FDA from approving the Smith & Nephew Birmingham metal-on-metal hip replacement system in 2006, citing a lack of solid data establishing the safety and efficacy of the device.
The Smith & Nephew Birmingham hip became the first metal-on-metal system approved in the United States, with other manufacturers soon following to introduce similar models, which have now been linked to an increased risk of failure and complications.
Wright Medical filed a citizen’s petition (PDF) with the FDA in 2006, asking the agency to reject the application for the Birmingham Hip Resurfacing (BHR), due to concerns over the adequacy of the clinical trials used to obtain premarket approval.
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The petition claimed that Smith & Nephew was misrepresenting the nature of the studies submitted to the FDA and of using bad science. For instance, Wright medical claimed that the company’s data on BHR safety and effectiveness came from just one orthopedic surgeon.
Wright Medical suggested that if the FDA approved the Smith & Nephew Birmingham, it would open the floodgates for companies to introduce potentially unsafe metal-on-metal hip replacement systems, with minimal clinical trials and testing. It now appears this is exactly what occurred.
The FDA ignored the petition and approved the Smith & Nephew Birmingham Hip Resurfacing system later that same year. The regulatory agency then continued to approve other metal-on-metal hip replacements, many of which have now been linked to a higher-than-expected failure rate caused by the metal debris that is released from the hip replacement as the metal parts rub against each other.
Problems with Metal-on-Metal Hip Replacements May Have Been Preventable
The petition raises further questions about whether the FDA could have prevented the recent problems with metal-on-metal hip replacements, which were implanted in hundreds of thousands of people throughout the United States before doctors began to notice a high rate of failures and complications.
Metal-on-metal hip replacement systems are a type of artificial hip that use cobalt and chromium metal femoral heads, which rest in a metal acetabular cup. The design quickly grew in popularity, amid aggressive marketing by the manufacturers, which suggested that the components were stronger and more durable than traditional hip replacements.
Concerns about the safety of metal-on-metal hip replacements gained national media attention in August 2010, when a recall was issued for DePuy ASR metal-on-metal hip systems after it was discovered that about one out of eight implants failed within five years, often resulting in the need for risky revision surgery. Unfortunately, more than 93,000 of the DePuy ASR hip replacements were sold worldwide before the recall, with about 40,000 implanted in the United States.
Following additional reports of problems with other metal-on-metal hip replacements that have been introduced, the FDA convened an advisory panel last month to look at the safety issues surrounding the implants. After determining that there was little, if any, reason for doctors to continue using metal-on-metal hips, the panel recommended that any individuals who received one of the implants should obtain annual x-rays to check for problems and should also receive blood tests to look for signs of chromium and cobalt ions in the blood if any pain or discomfort develops.
Metal Hip Lawsuits Over Failure to Adequately Research Design
Thousand of individuals who experienced problems after receiving a metal-on-metal hip replacement are now pursuing a product liability lawsuit against the device manufacturers, alleging that they failed to adequately study the design before introducing it and marketing it as safe and effective.
More than 6,000 DePuy ASR lawsuits have been filed by individuals who received one of the recalled components, but large numbers of complaints have also been filed over issues with the DePuy Pinnacle hip, Wright Conserve hip, Biomet Magnum hip and others.
Reports have suggested that as many as half a million Americans have received an all-metal hip replacement, and a sizeable percentage of them are likely to pursue a lawsuit after their implants fail.
The first metal-on-metal hip replacement trial dates are scheduled to begin in December 2012, and estimates have suggested that the manufacturers will face billions in legal costs and settlements over metal-on-metal hip replacements.
CharmaineApril 20, 2014 at 6:52 am
I had a BHR in 2007 in my R hip and 2009 in my L hip. I began having issues after the first was implanted, but didn't relate it to the hip as it didn't seem connected. I had a difficult time thinking straight, was unable to complete my dissertation, fatigued. I couldn't lift my leg because the tendon running from my stomach into my thigh was weak and sore. If I stubbed my toe I went through th[Show More]I had a BHR in 2007 in my R hip and 2009 in my L hip. I began having issues after the first was implanted, but didn't relate it to the hip as it didn't seem connected. I had a difficult time thinking straight, was unable to complete my dissertation, fatigued. I couldn't lift my leg because the tendon running from my stomach into my thigh was weak and sore. If I stubbed my toe I went through the roof with pain. I lost a huge amount of my range of motion and could no longer bring my ankle to my knee or even come close to it. It squeaked and would grind if I bent a certain way. I thought it was just something that I would need to get used to and figured no implant would be as good as the original. With the fatigue and problems with memory and putting my thoughts together, I thought I was depressed or something because I had just relocated and I hadn't wanted to, but had made a huge sacrifice to follow my husband, leaving my job and the house I loved in Florida. When the second one was done, that was when the really major issues began. Within days after the surgery I began having bloating and gas issues, which was humiliating for me. I had had a gastric bypass in 02 with no problems and had maintained my weight for 9 years easily and suddenly I began putting on weight, even though I wasn't eating any more than I had before. The bloating was so bad I felt like I couldn't breathe and nearly called 911 several times, but couldn't bring myself to go through the humiliation of being carted off by ambulance only to find it was gas buildup -- which was made worse because of the limited space in my stomach. It was suggested by someone that I may have a yeast infection in my gut and so I told my PC this and he humored me and gave me a month of diflucan, which gave me instant relief, however he had never heard of a yeast infection in a gut. I went to doctor after doctor over the gas issue and all blew me off and then the PC took me off diflucan and I was utterly miserable. I stopped eating gluten and that helped and took naturopath yeast products and finally managed to get it under control as long as I followed a strict regimen. Unfortunately every time I had to take antibiotics, it would rear its ugly head again and it seemed I kept getting urinary infections over and over, as well, which meant I was always battling either one infection or the other. No doctor in my area had ever heard of it because it is normally only relegated to AIDS patients so none would believe I had it. Then I began sweating profusely. It was so bad it would drip in my eyes at all hours of the day, all day long. I had to carry a towel around my neck because it was so bad and my hair was always plastered to my head, looking like I just showered. I couldn't remember simple things any longer and had a constant feeling of being unwellness, where it got to where I could no longer work. After gaining 50 pounds and being told by a bariatric surgeon that I was being irresponsible with the gift of a gastric bypass by not following directions in my eating habits (I WAS following directions!), it was finally found that the gas had stretched a part of my intestine from the size of a thumb to the size of a fist. A portion of food was no longer digesting at all and was forming a hard rock-like mass that was destined to get larger over time. When they did a colonoscopy they found a thumb-sized mass that ended up being caught just in time because it was cancerous, although it hadn't yet spread, luckily, and was removed. Then it was found I had a thyroid issue and I was put on levothyroxine. My hair began falling out and became thin and brittle and I couldn't seem to get anything done during the day as it seemed to pass by so quickly. I wasn't sleeping and still the day went by so fast but I just couldn't seem to get myself together. Finally, I saw something about chromium and cobalt poisoning symptoms and it was like looking at my life for the last several years when viewing the symptom list. I immediately had my PC do a test and lo and behold, my levels were very high. I took them to my surgeon who was alarmed, ordered another test, and an MRI, which showed fluid around the implants on both sides. He immediately scheduled me for surgery and I had the R hip revised with a ceramic full replacement in March. I feel so much better. I can think again! The sweating has decreased. I am due to have the L hip done next month and even though it has been painful, I can't express the difference in my well-being adequately, as it is truly miraculous. I feel like I can get my life back again. In the meantime, I have been told that S&N cannot be held liable even though they knew about all of the dangers involved because of a Premarket Approval by the FDA. I am angry and I have asked the FDA to rescind the PMA, but until we all band together, it probably won't happen. Contact me if you had this implant because maybe if we all band together we can achieve something to make S&N own up and pay restitution for destroying my life for five years that I can never get back.
JonJune 25, 2013 at 10:27 pm
I had the BHR implant done in 2009 by Dr. Bose and it has failed. I am waiting to get an MRI. I had the surgery done after watching the 60 minutes expose recommending medical tourism and Dr. Bose. Has anyone else used Dr. Bose and problems with the BHR?
HowardJuly 27, 2012 at 12:39 pm
You may want to read the minutes of an FDA meeting held in Washington, DC on September 8, 2005. The main reason for this meeting was to approve the birmingham resurfacing hip device manufacturerd by Smith and Nephew. You will see there were major concerns and questions raised at this meeting about this device and YET it was approved by a 3-2 vote??? The partial inventor of this device worked for S[Show More]You may want to read the minutes of an FDA meeting held in Washington, DC on September 8, 2005. The main reason for this meeting was to approve the birmingham resurfacing hip device manufacturerd by Smith and Nephew. You will see there were major concerns and questions raised at this meeting about this device and YET it was approved by a 3-2 vote??? The partial inventor of this device worked for Smith & Nephew in one breath and then he became a consultant?? he controlled the patient group of 2385, he had a financial interest that reportedly was worth in excess of $150 million dollars, there were serious concerns raised about lack of data on metal shavings (caused from friction of components rubbing together) entering the human body and what the outcome could be, the controlled group was taken from non USA citizens, and there were other issues raised.
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