Any surgery may have potential complications, research findings show. The complexity of revision joint surgery increases the chance of developing intricacies. One reason for a primary hip surgery failure is a defective hip device, as was noted in the recalled devices of pharmaceutical giant Johnson & Johnson. The  company has announced that hip replacement recall costs $3 billion quarterly, as was reported by Reuters.

Revision surgery helps to correct the problem so the hip can function normally again. The use of artificial hip implants is extremely effective in improving hip joints that are damaged by injury or some form of arthritis. Artificial joints, including hip joints, do not last forever. The typical life of an artificial hip joint is 10-15 years, depending on the patient’s daily use of it, experts say.

During hip replacement surgery, the diseased portions of the hip are replaced with an artificial hip joint. With hip revision surgery, the artificial hip joint is removed and replaced with a new one. Depending on the severity of the infection, more than one hip revision surgery may be required. In more severe cases, the first surgery will be needed to remove the old prosthesis scar tissue and treat the joint with antibiotics for the infection. When the hip is cured of infection, surgery is performed to provide a new prosthetic.

Infection, bleeding, and trauma to nerves or blood vessels are  potential justifications for surgery. The risk of these complications is higher than primary procedures.

The decision to perform revision joint surgery is made when the benefits of pain relief and functional improvement outweigh the risk of the potential complications. Regarding the DePuy hip replacement recall, the public should be informed about potential harms of hip devices that may lead to a hip revision surgery.

References:

• my.clevelandclinic.org/services/hip_revision/or_overview.aspx
• orthopedics.about.com/od/hipkneereplacement/a/revisionhip.htm
• evertsmith.com/treatment/hip-revision/

On August 24, 2010, DePuy Orthopaedics issued a voluntary recall on its ASR XL Acetabular System and the ASR Hip Resurfacing System. This decision was also heeded by the US Food and Drug Administration.A senior FDA official urges smart regulation in the wake of the DePuy recall.
 
he recall was voluntarily done by DePuy Orthopaedics in response to the data presented by an independent national registry from UK. It was shown in the data that 12 percent of the patients who had an ASR resurfacing device for the past five years had to undergo hip revision surgery.  The data also showed that within five years of having an ASR total hip replacement, 13 percent of the patients have had revision surgery.
 
The FDA has been taking measures to come up with suited interventions for the metal-on-metal hip implant crisis, like the DePuy recall. Several areas are currently worked on by FDA for them to thoroughly assess the safety and effectiveness of MoM hip implants. The agency is requesting and reviewing device retrieval analyses from hip device manufacturers.The FDA continues to review published literature, Medical Device Reports, post-approval study reports and data from several orthopedic device registries. Published literature, Medical Device Reports, post-approval study reports and data from several orthopedic registries are continuously reviewed upon by the FDA.   This is their way of better understanding the adverse events associated with metal debris on MoM hip systems.
 
Device manufacturers of metal-on-metal hip implants are to conduct post-market surveillance studies as ordered by the FDA on May 6, 2011. The FDA will receive research protocols on specific safety issues regarding the affected devices from manufacturers. From the given data, the agency will have a clearer view on the nature and safety of the artificial hips.
 
An FDA official urges smart regulation on these devices, as reported during the recently concluded Biotech conference.Dr. Jeffrey Shuren, director of the FDA Center for Devices and Radiological Health, remarked that the federal government needs to carry out strict policy enforcement. Shuren mentioned, “We needed to move away from this pendulum-swing approach, away from the idea of it's more regulation or less regulation. It's about smart regulation."  He further commented “It’s not safety or innovation. It’s safety AND innovation.”
 
Dr. Shuren emphasized that the FDA should redefine its role. "We needed to move away from this construct that safety and effectiveness and facilitating innovation are incompatible. They are both sides of our mission," he says.
 
Patients who had the device are to continuously submit themselves for check-up, the FDA recommends. The FDA strongly suggests that patients who are and are not experiencing DePuy hip symptoms ask for help from their attending doctor.
 
Reference:
mtstandard.com/lifestyles/health-med-fit/fda-official-talks-up-smart-regulation-at-biotech-conference/article_b04fe626-fee9-11e0-85bb-001cc4c002e0.html

articles.philly.com/2011-10-25/business/30320404_1_jeffrey-shuren-mark-leahey-artificial-hips
depuy.com/asr-hip-replacement-recall

fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/MetalonMetalHipImplants/ucm241769.htm

The highly dynamic technology of hip implants has coped up with the various concerns of hip-replacement patients. The metal-on-metal device, which uses the cobalt-chrome alloy, is one of the widely used implant. Though it was proven to be effective, the device earned negative feedback from its users. On an article recently published in the New York Times, more evidence that metal-on-metal hip implants cause tissue damage was provided.

Because the ball and the cup slide against each other during walking or running, fragments of the device may be shed off. Small pieces of the detached metal may affect the tissues near the injured area or it may enter into the bloodstream. Metallosis or metal poisoning may develop if the blood metal level does not subside. This condition may affect other organs of the body, including the brain, lungs, heart and the endocrine system.

Patients will react to the metal toxicity differently. According to the US Food and Drug Administration, at this time it is impossible to know who among the patients will experience a reaction, what type of reaction they might have, when the reaction will occur, or how severe the reaction will be.   Nonetheless, it has been found out that implant loosening and pain resulted from these reactions. Recipients of the all-metal hip implants should be aware of the potential symptoms which may occur after surgery indicating that their device is not functioning well. Symptoms normally include pain in the groin, hip or leg; swelling at or near the hip joint; or a limp or change in walking ability.

The American edition of the Journal of Bone and Joint Surgery has reported that 2 patients had adverse reactions. Cobalt toxicity developed within their bodies after the MoM device was implanted and the symptoms were alleviated after the implants were removed.

As the ball rotates and rubs against the cuplike socket, debris is created, regardless of the material used in a hip device. But in metal-on-metal hips, the ball can sometimes press against the cup’s edge producing large volumes of metal particles. This may be caused by poor hip design or poor implant technique.

Symptomatic and asymptomatic patients, alike, are advised by the FDA to have a regular check-up with their orthopedic surgeons. Though device manufacturers have taken actions about the concern, like the DePuy Orthopedics’ worldwide hip replacement recall, they were mandated by the FDA to conduct post market surveillance studies on their products.

Reference:

prnewswire.com/news-releases/metal-on-metal-hip-replacement-orthopaedic-surgeons-provide-awareness-and-information-to-patients-medical-community-at-large-106323583.html

fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/MetalonMetalHipImplants/ucm241604.htm

medicalnewstoday.com/releases/226573.php

nytimes.com/2010/03/04/health/04metalhip.html

bonesmart.org/hip/metal-on-metal-hip-implant-recalls/

Preamendment device, like the metal-on-metal hip systems, is classified as a Class III or higher risk devices by the US Food and Drug Administration. On 1976, FDA was given a premarket authority over medical devices, and equipments marketed before that were considered “preamendment device”.  The FDA has 510(k) premarket notification program which regulates these devices. However, study shows that metal-on-metal hip implants present some complications and many recipients of the device have experienced major problems and have taken legal actions. According to the New York Times, there was an enormous climb in metal-on-metal device complaints this year, higher than the previous four years combined.

The FDA’s 510(k) approval process was criticized by the Institute of Medicine for it did not provide “a reliable and premarket screen of the safety and effectiveness” of devices submitted for approval. After the report was released, FDA made a statement that they would be “open to additional proposals and approaches for continued improvement of our device review programs.”

A medical device alert was issued by the United Kingdom’s Medicines and Healthcare products Regulatory Agency on April 2010, indicating specific follow-up recommendations for patients who received MoM hip implants. Included in the recommendations are imaging and blood tests for patients experiencing pain. DePuy Orthopedics voluntarily recalled their DePuy ASR hip on August 2010.  The UK joint registry had new, unpublished data indicating the revision rates of the DePuy ASR hip within 5 years were roughly 13 percent.

The safety and effectiveness of metal-on-metal hip implants is further evaluated by the FDA by looking and assessing at different areas.  The agency has requested MoM hip implant manufacturers to submit device retrieval analyses. FDA continues to review published literature, Medical Device Reports, post-approval study reports and data from several orthopedic device registries.  With this strategy, they can have a clearer view and understanding of the association between metal debris and MoM hip systems.

Patients with MoM hip implants who are showing negative symptoms of device malfunction are not required to undergo blood tests and special imaging. The FDA recommends that asymptomatic patients continue to follow-up with their orthopedic surgeon as prescribed.  Patients who are slowly developing symptoms of complication are advised to seek early help from orthopedic surgeon for major complications like DePuy hip recall to be prevented.

The recalled hip implants from DePuy Orthopaedics was of a metal-on-metal design. Surgeons were first keen to use the new design, but after increasing reports about some premature complications seen in implanted hip devices, they had second thoughts of using it. It was believed that the complications were brought by the metal-on-metal design. There seems to be another issue handled by the J&J company right now notwithstanding the DePuy hip replacement recall.

Worldwide, about 93, 000 recipients underwent a hip replacement surgery using the DePuy Orthopedics' ASR XL Acetabular System and the ASR Hip Resurfacing System. The hip implants allegedly caused early failings which made the product not a favorite choice of most surgeons. There were people who believe that the devices mentioned could be defective and dangerous based from reports and some from experience.

Premature loosening of the hip implant, dislocation of the device and possible fracture of the bone surrounding the hip implant are some of the complications allegedly caused by the hip replacement devices. One complication can potentate the other and a revision surgery may be necessary for serious cases. A revision surgery could mean added expenses on the surgical management as well as added pain, inconvenience brought by the time needed to fully recover from the surgery such as days of leave from the office as well as absences from school, and discomforts from the changes in ones lifestyle.

Another complication which was associated with the metal-on-metal design is metallosis. This condition can occur if there is an abnormally high level of toxic heavy metal in a person's bloodstream. A blood test is conducted to confirm or refute this. The two most commonly detected heavy metals in the cases related hip device is cobalt and chromium. As the hip implant fails, heavy metal debris accumulates around the device which could be absorbed by the surrounding tissues.

A condition known as Asceptic Lymphocyte-dominated Vasculitis Associated Lesion (ALVAL) is an adverse reaction of the affected tissues from the toxic accumulation of selected metals. The term "vasculitis" means that there is inflammation of the veins which could potentially cause serious effects to the body. Affected tissues were said to form pseudotumors or “false” tumors. Consulting an adept doctor regularly is crucial for those who had a hip arthroplasty using any of the metal-designed hip replacement devices.

If you had a hip arthroplasty and used any of the two aforementioned hip products from DePuy Orthopaedics, one can have a full laboratory exam to check for any complications from the DePuy hip prostheses thanks to the issuance of a DePuy hip recall. You can learn more about this if you visit other sites related to the topic.

Recipients of orthopedic manufacturer DePuy's hip implants are speculating about the monetary reward they would receive as the litigation progresses. Ever since two of DePuy's hip devices, namely ASR XL Acetabular System and ASR Hip Resurfacing System, were withdrawn from the worldwide market, quite a number of recipients have come forward to seek damages from the company, like the case of three plaintiffs in Minnesota who filed a DePuy lawsuit. Handing over the full payment is not something DePuy is inclined to do. Having a DePuy recall lawyer to help you with the lawsuit is the one of the first steps you would need to take toward achieving compensation.

While a good lawyer is important in your fight against DePuy, he or she still needs your help. While a good lawyer is important in your fight against DePuy, he or she still needs your help. They would be:

Medical records. Medical tests and procedures accompanied by necessary documentation that are involved with your DePuy hip recall injury is crucial. Records detailing any procedure or tests should be kept. Just as important are the bills and reciepts for the tests.

Summary of expenses. This is a list of items or services you need to purchase or hire that is relevant to your injury such as crutches, medication, and a personal caretaker. Hospital and medical bills should not be the only expense covered.

Employer records. There were times you cannot come to work because of the intense pain you are going through due to the hip replacement device or because of doctor's appointments. By not coming to work, you lose your day's pay. Those times you weren't able to work should be compensated for as well.

Journal and photographs. A journal that chronicles the pain you have experienced that affects your work, daily routine, relationships and your quality of life would provide an insight as to gravity of your situation. Pictures of outward swelling of your hips would also serve as a visual proof of your injury.

Physical evidence. If you've undergone a revision surgery and had your ASR hip replacement device removed, the implant could serve as physical evidence that the ASR indeed was defective and caused much damage. DePuy seeks to be in possession of your extracted artificial hip claiming they need to run some tests on it. But do keep in mind you are under no obligation to give it to the company. Your explanted hip replacement could be a key evidence in your lawsuit.

The evidence collected that pertains to the DePuy lawsuit could greatly help your hip recall lawyer. Your lawyer might ask for more items you need to procure but the items above is a priority. All efforts could pay off leading you to finally receive the monetary award you have a right to obtain. For a free consultation on the matter, you could visit the DePuy ASR Hip Recall information center and claim the compensation you deserve.

The DePuy hip replacement recall is just one of many under Pharmaceutical giant Johnson & Johnson. From April 2010 alone, recalls of 40 J&J products were due to manufacturing defects and other major risk factors. Well known medications such as Tylenol and Motrin to the current and widely used DePuy hip implants are under the scrutiny of the public and the U.S. Food and Drug Administration. Observing how J&J responds to its former recalls may shed some light on how impending hip replacement lawsuits may proceed.

In the fall of 2010, J&J CEO William Weldon stood before Congress and apologized for the “letting the public down” with its slew of recalls resulting from the poor state of the manufacturing equipment and contaminated drugs. He also had to stand before Congress to explain the poor handling of J&J’s product recalls, particularly the questionable practice of hiring contractors to buy up shelf stocks of defective Motrin. This was done in order to avoid revealing to the public the existence of a defective product and the need for its recall.

The existence of these “phantom recalls” prompted such government agencies as the House Committee on Oversight and Government Reform as well as the U.S. Food and Drug administration to take action. Adding to the impropriety of the situation, it was found out that these hired contractors were told to pose as regular customers while buying the potentially harmful drugs off the shelves of stores nationwide.

When questioned about the phantom recall, the Head of Consumer Businesses at J&J initially testified that she “wasn’t aware” of the company hiring contractors for this purpose. She later changed her testimony on this subject.

It is clear that DePuy’s parent company has a lot of explaining to do with regards to the apparent lack of sufficient quality control and continuing disregard for public health and safety. With the encouragement practicing phantom recalls in order to avoid public awareness of other defective products, it is not surprising that J&J and DePuy are encouraging victims to sign away their legal rights in exchange for uncertain settlements and quiet returns of any hip replacement products after surgical removal. The questionable ethical practices of J&J with regards to the previous recall of their defective J&J products are another reason why victims of DePuy’s hip replacement recall need experienced legal counsel. For more information regarding ongoing litigation, please visit the DePuy hip recall settlement website.