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Hip Replacement Lawsuit Funding
The US FDA (US Food and Drug Administration) has issued multiple warnings on hip replacement products and manufacturers after receiving increasing numbers of complaints from victims who have undergone one or more hip replacement procedures.
Hip Replacement Surgery; A Real Pain in the … Hip
Some of these manufacturers were Biomet, DePuy Orthopedics, Wright Medical Technologies, Zimmer Inc. and Stryker Howmedica Osteonics. Lawsuits have been filed by plaintiffs to receive compensation for medical expenses, emotional and physical pain and psychological issues.
Biomet Hip Recall
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DePuy Hip Recall
In August 2010, DePuy Orthopedics, a division of Johnson & Johnson, recalled two of its product (ASR Hip Resurfacing System and ASR XL Acetabular Hip Replacement System) after implanted almost 93,000 defective hip replacement and failure rates as high as 15% have been observed. The recall was issued after a report from National Joint Registry of England, showing patients experience from side effects brought by the hip implant.
Patients were entitled a monetary compensation since the discovery of DePuy’s defective products.
Stryker Hip Recall
The FDA issued two warning letters to Stryker Howmedica due to violations of appropriate standards of sterility. The Trident Ceramic Acetabular System was an artificial hip implant featuring ceramic-on-ceramic bearing couple but patients who have received the defective replacements have filed lawsuits because of adverse effects like broken bones and difficulty in walking.
In January 2008, Stryker finally recalled two components for the Trident Hip replacement: the Trident Acetabular PSL Cup and the Trident Hemispherical Cups.
You can learn more about Stryker lawsuit funding here.
Zimmer Hip Recall
Zimmer Inc. manufactured a product for total hip arthroplasty procedure called Durom Cup. Durom Cup was made of metal alloy implant to reduce susceptibility toward other traditional hip replacement problems. Approximately 13,000 hip replacement surgeries were done before it was discovered that 5% of patients suffered from complications.
Durom® Acetabular Component (Durom Cup) was recalled on January 22, 2008 due to inadequate surgical technique instructions. Zimmer Inc. faced a number of lawsuits filed by patients expecting that hip implant would at least last for 15 years.
Click here for more information about Zimmer hip settlement loans.
Wright Hip Recall
Like with many other hip replacement products, Wright Medical Technologies used 510(k) pre-market approval to endorse its product Profemur Plasma Z Hip Stem on the market. Profemur was a metal-to-metal hip implant used in minimally invasive surgery. Hip replacement failure rate of 11.2% was reported by Australian National Joint Registry after three years of first product released. Four devices of Wright “Conserve” hip implants have been named in the lawsuits. These were Conserve Femoral Surface Replacement, Conserve plus Total Resurfacing Hip System, Conserve Total A-Class Advanced Metal and the Conserve Total Hip System.
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About Hip Replacement Surgery
Hip replacement surgery is the most common operation to be done in the orthopaedic world. Although many people associate hip replacement surgery with the elderly, it is very common for other individuals with certain ailments or conditions to have hip replacement surgery done as well. Hip replacement surgery is also often done in people with overweight issues. Because the body is too heavy, the legs and its joints are no longer strong and capable enough to support the upper body. For individuals suffering severe hip pains with an overweight condition, hip replacement surgery is no surprise. Hip replacement surgery is very difficult and complicated. Because there are various types and categories of implant systems, it is difficult to pinpoint which one type is suitable for a patient.
The medical world thought it had a break through with cutting edge design and innovation on metal hip implants. However, results have shown that metal implants have shown no greater improvement on the lives of patients due to its severe side effects.
Hip replacement surgeries are designed to aid in long-term benefits in its patients. The life expectancy of implants is 10 to 20 years. It is understood that these implants are not meant to last the rest of a patient’s life due to wear and tear of the artificial parts of the implant. However, reports have been made that metal implants break down and cause adverse effects on patients within just a mere five years. Because hip implants cause complications like pain and disability, revision surgeries are often recommended and performed. However, most revision surgeries have less successful results than that of initial surgeries. Reports have surfaced that only 2% of hip replacement surgeries require a second surgery within five years after the first surgery.
Many patients have filed lawsuits against manufacturers with claims alleging that the manufacturers made defective products and failed to warn about health risks. As many as six manufacturers have been facing years of lawsuits from patients suffering the side effects from these metal-on-metal hip implants; with more lawsuits expected to be filed since the manufacturers have refused to stop selling the products, and the FDA’s refusal to ban the devices from being sold in the market as well.
Hip Replacement Lawsuits and Litigation
Thousands of lawsuits have been filed against hip replacement manufacturers for failing to fulfill their promises of reduced pain and greater mobility after developing more life threatening complications. Lawsuits claim that the attained complications were a result of faulty designs and other severe complications; specifically, metallosis.
Many implant manufacturers are involved in lawsuits because of patients suffering from complications. Claims from plaintiffs say that the manufacturer made defective products and failing to warn about health risks. These companies include DePuy, Stryker, Zimmer, Biomet, Wright Medical and Smith & Nephew.
DePuy faces 12,000 lawsuits just for the ASR implants, and another 3,000 lawsuits for the Pinnacle hip. Reports say that DePuy will settle 7,500 ASR claims by paying $2.5 billion.
In January 2013, the first ASR trial jury had gotten evidence, during the time of the recall, of DePuy’s knowledge of the product failure of 40% of its ASR implants. The company reportedly knew about the product failure rate for five years.
Plaintiffs can claim compensation from the drug manufacturers for medical bills, pain and suffering, and lost wages and damaged relationships. Realistically speaking, it’s better to file for a lawsuit than to demand a recall. Lawsuits can offer more than just compensation as compared to a recall. Compensation limits the coverage that they give to patients who ask for a recall. Potential losses like lost wages and pain and suffering are unlikely to be given any kind of compensation.
Class action lawsuits can be also be done by plaintiffs; these lawsuits are consolidated into one due to similar claims filed by patients. However, joining a class-action lawsuit limits the plaintiff’s control over cases including negotiation of terms in the case of a settlement. Groups who file for class action lawsuits, though, usually have the leverage to gain hefty settlement amounts. Settlements are also a good option for plaintiffs. Each case is different, so it’s only right for injured patients to weigh in the pros and cons of each option before coming to a decision.
Need to Know About Hip Replacements
Hip replacement is a surgical procedure where an artificial implant is surgically replaced on a damaged hip joint. The artificial implant, called a prosthesis, helps reduce the pain and improve function in patients who have undergone the surgery.
Also known as a total hip arthroplasty, the hip replacement procedure is applicable to individuals whose hip pains get in the way of day-to-day activities and less-invasive treatments have not improved the situation. One of the most common reasons for hip replacement is arthritis damage, hence the surgery’s popularity in elderly patients.
Most conditions that more often need hip replacement surgery are patients who are overweight, Osteoporosis – thinning of the bones, Osteoarthritis – the damaging of cartilage that covers and protects the ends of bones, Rheumatoid arthritis – a type of inflammation that has the capacity to erode bone and cartilage as well as deform joints, and Osteonecrosis – loss of blood supply in the bones resulting in bone collapsing and deformity.
Hip replacement implants normally use devices that have metal, ceramic or plastic parts to replace the ball on the hip that connects the thighbone to the pelvic bone. The implants basically replace the already damaged cartilages in the hip area. Doctors also have the option to adjoin the implant to the pelvic hip by the use of cement.
In FDA news release entitled, “FDA to discuss risks and benefits of metal-on-metal hip replacements,” on March 2012, the FDA further clarified information regarding metal-on-metal hip replacement implants. They stated the two categories of the systems: metal-on-metal total hip replacement systems and metal-on-metal hip resurfacing systems. The former consists of a metal ball, which is the femoral head; a metal femoral stem in the thighbone; and a metal cup in the hip bone, which is the acetabular component of the device. The latter, on the other hand, possesses a trimmed femoral head capped with a metal covering; and a metal cup in the hip bone, which is also the acetabular component.
In the same article, the FDA stated the hip replacement surgery is designed to contribute to patient mobility and reduced pain by replacing the damaged joints in patients, as long as the patients have adequate sound bone to carry and reinforce the components of the implant.
Problematic Hip Implants
All-metal devices were deemed to last longer than the other implants on the market. However, many patients who have used these implants have damaged many patients in more ways than one. The following implants are naturally to be avoided due to their ability to cause grave injuries on an implant recipient:
- DePuy Orthopaedics’ ASR XL Acetabular System, ASR Hip Resurfacing System, AML, Pinnacle, Prodigy, S-ROM, and Marathon
- Biomet’s M2a metal-on-metal hip devices, Mallory-Head, and Taperloc
- Zimmer Holdings’ Durom Cup or Durom Acetabular Component, VerSys, Mayo Hip, and Longevity
- Wright Medical Technology’s Conserve Plus and Profemur Z Hip Stem, Perfecta, Dynasty, and Metal Transcend
- Stryker Orthopaedics’ ABG II modular-neck hip stems, Rejuvenate, Omnifit, Sulzer Inter-Op acetabular shell, Exeter, Crossfire, and Trident Hemispherical SH
- Smith & Nephew’s R3 Acetabular metal liner, Duo, IVS Tunneler, TriGen Hip Nail, Synergy, and Birmingham Hip Resurfacing
- Exactech’s Metal liner of R3 Acetabular System, and Opteon
- Encore Orthopedics’ Foundation, Linear, and Revelation
- Corin’s Cormet 2000
- Centerpulse’s Orthadapt, and Inter-Op
Hip Replacement Complications
When implants have at least two metal parts, odds can lead to severe complications on patients when the metal sheds its particles onto the surround tissue of the body. This can lead to the following risks:
- Metal poisoning, metal toxicity, metal sensitivity, or metallosis
- Decreased mobility
- Vein thrombosis
- Pulmonary embolism
- Bone damage
- Loosening of the device
- Severe or chronic pain in the hip, groin or thigh areas
- Inflammation and swelling that could also lead to infections
- Blood clots
- Hip joint failure
- Even inequality in leg length
FDA Recalls, Warnings and Reports
Over the past two decades, hip replacement devices or implants have gained much popularity. New innovative designs with promises of increased mobility have been the reason for patients to seek for the use of hip implants.
DePuy Orthopaedics had a hip replacement recall in 2010, which surfaced issues on potentially serious injuries that could be contracted from the use of these devices. It was reported that DePuy had spent $800 million on this recall on the Articular Surface Replacement (ASR) Acetabular Hip System and ASR Hip Resurfacing System. The company voluntarily initiated the recall after the U.K. Joint Registry’s unpublished data showed that metal devices are not more stable as promised. In fact, metal devices had more problems than older devices.
Around three years after the FDA approved the Rejuvenate and ABG II hips systems, Stryker also issued a voluntary recall of the medical devices in July of 2012. Stryker received post-market data that showed that parts of their devices were prone to corrosion and the fear that excessive metal debris would be lodged in to the body which can also lead to damaging the surrounding bone and tissue; this was the reason behind Stryker’s recall of the products.
A study in 2003 was published in the Iowa Orthopaedic Journal. It reviewed almost 5,000 hip arthroplasty surgeries. It was found that mortality was nearly 1% in patients getting hip replacement surgery for the first time. Revision surgeries had a 2.5% mortality rate. Patients over the age of 70 were three times more likely to result in deaths as compared to younger patients going through the same kind of surgery.
The National Joint Registry of England and Wales published reports in September 2011 that the DePuy ASR Acetabular implant was either replaced or removed 29% of the time after six years of use. This was in comparison to an overall 9.5% failure rate for all-metal hip implants.
The Medicines and Healthcare Products Regulatory Agency in United Kingdom had its annual monitoring regime for hip replacement patients that used metal-on-metal devices from May 2010. The Australian Orthopaedic Associations’ 2008 National Joint Replacement Registry showed data tracking 6,773 Birmingham Hip Ressurfacing Hips. It was found that less than 1/3 of 1% could possibly have been changed due to the patients’ reaction to the metal component.
The Lancet published a study in March 2012 based on the data derived from the National Joint registry of England and Wales. Studies found that metal-on-metal hip replacement implants had greater rates of failure as compared to other types of hip implants. It was urged that the metal-on-metal hip replacement implant be banned.
40,051 hip replacements were analyzed and results reveal that 6.2% of the metal-on-metal implants failed within five years, in comparison with metal-on-plastic having 1.7%, and ceramic-non-ceramic implants with a rate of 2.3%. An increase of 2% in failure was also associated with each 1mm increase in head size of the metal-on-metal hip implants. British Hip Society surgeons recommend that large heads of metal-on-metal implants should no longer be done.
It was in February 2011 when the FDA posted on its website a public health and safety communication message, and launched a webpage regarding metal-on-metal hip implants. The agency stated that they were still taking action on trying to gather and review all accessible information dealing with the type of hip implant systems.
On March 29, 2012, the FDA released an article on their News & Events webpage regarding the FDA’s plan to discuss the risks and benefits of metal-on-metal hip replacement implants. It announced the search for expert scientific and clinical advice on the risks and benefits of the said type of medical device. They are also seeking to find and secure information on potential patient and practitioner recommendations on the use of the metal hip implants, as well as managing the patients that were implanted with the devices. The discussion was set for a two-day expert advisory meeting on June 2012.
The FDA had also issued an order in May 2011, requiring metal-on-metal hip implant manufacturers to perform 522 post-market surveillance studies to gather more data regarding safety issues, including metal ion concentrations in the bloodstream. metal-on-metal total hip replacement systems.
On June 27-28, 2012, the FDA’s Orthopedic and Rehabilitation Devices Advisory Panel discussed whether to implement new regulations and standards regarding he type of medical device, taking The Lancet, Australian and United Kingdom Orthopaedic Device Registries findings into consideration with regard to the decisions to be made. The two latter institutions have the biggest number or patients and the longest length of follow-up time. They have indicated that around 95% of patients with any kind of total hip replacement have not gone through revision surgery. Standards were not set, but guidance was updated.
The FDA currently does not require clinical trial testing on hip implants before being sold in the United States. Rather, companies that are making new innovations to hip replacement implants need to prove that they are essentially equivalent to other already approved hip implants that are out in the market. Metal-on-metal implants, however, are an exception to this rule. These devices were not tested through clinical trials. Due to the high revision rate of metal-on-metal implants, the FDA has stated that in the future, clinical trials will also be required for approval; as well as post-market studies, in order to keep the medical devices on the market.
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