Recall Lawsuit
Cooper Vision Avaira Toric Contact Lens Lawsuit
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Cooper Vision Avaira Toric Contact Lens Lawsuit
A class-action lawsuit filed by CooperVision shareholders in December 2011 has accused the eye healthcare manufacturer of hiding information about the low quality of its products and presence of silicone oil residues in Avaria Toric and Sphere contact lenses until the FDA called for their market withdrawal. In 2011, CooperVision recalled 6.6 million Avaria Toric and Sphere Contact Lenses, meant for the treatment of nearsightedness and farsightedness in patients suffering from astigmatism. According to the FDA and independent research reports, Avaria contact lenses could lead to potentially serious eye complications, including distorted vision, torn corneas, and even loss of vision.
Cooper Vision Recalls Avaria Contact Lenses
In August 2011, CooperVision issued a voluntary recall of its Avaria Toric contact lenses after receiving complaints from patients about the serious side effects of using the product. On August 19, 2011, CooperVision issued a limited recall to some healthcare professionals and distributors in the United States. A week later, it issued a notice to foreign distributors about the recall of the contact lenses over some “unidentified residue” that had spilled on the lenses; however, the manufacturer failed to send any public notification about the dangers of using the product. It posted a press release about the limited recall on its website, but did not distribute it publicly, thus failing to inform the public at large about the recall and possible side effects of the product. The manufacturer did not bother to adequately notify consumers that the silicone residue was creating problems and that they might have already been exposed to it.
On November 15, 2011, CooperVision issued a massive recall of both Avaira Sphere and Toric Contact Lenses under pressure from the FDA. The company expanded the earlier recall to include more than six million Sphere contact lenses after having identified that certain lots did not meet the updated quality standards due to the unintended presence of silicone oil residue. The recall affects contact lenses manufactured between November 2010 and August 2011. Before the November recall, the FDA estimated that about 778,301 of the distributed contact lenses were thought to have been affected by the recall.
Smith Nephew Hip Replacement Implant Recall Lawsuit
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Hip Replacement Recall Lawsuit
Smith & Nephew Birmingham Hip Replacement Recall
In 2007, Smith & Nephew recalled about 185 Birmingham hip resurfacing system implants over improper packaging by a subcontractor. As a result of the packaging error, it was reported that different sizes of acetabular cups were mixed and mislabeled. A number of patients have complained of having received wrong-sized hips, which has forced them to undergo a revision surgery to remove and replace the improperly fitting hip that has been wearing out quickly and causing extreme complications for them.
Smith & Nephew blamed the error on a subcontractor that mislabeled the
devices, which caused a mismatch between the two hip implants. This meant that patients requiring a hip device of a different size received a mislabeled hip implant, which resulted in their hip implant failure.
The mismatched pieces result in loosely fitting implants. Patients that have undergone hip replacement surgery using Smith & Nephew Birmingham hip device are advised to consult their doctors and go for a post-operation X-ray to confirm whether they have properly fitting implants.
In case they are found to have the improperly fitting hip device, revision surgery is the only solution.
Recently, the
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DePuy Hip Replacement Recall Lawsuit
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DePuy Hip Replacement Recall Lawsuit
DePuy Pinnacle Hip Replacement Implant Ultamet Recall
Following the DePuy ASR recall, there have been numerous complaints that DePuy Pinnacle hip implant is causing similar problems when used with a metal liner. Patients and doctors demand that, with more than 1,300 adverse event reports filed with the FDA against Pinnacle hip implant, it is high time DePuy Orthopedics issued a recall for the device, which is reported to have a 13 percent failure rate. The device is linked to potential side effects, including severe pain, hip dislocation, hip replacement failure, metal toxicity, and need for a revision surgery in many cases.
The FDA approved the DePuy Pinnacle® Ultamet® metal acetabular inserts in 2001. However, not all Pinnacle hip devices are metal on metal, but the metal bearing surface poses the risk of revision compared to other bearing surfaces, including plastic, polyethylene, ceramic, and polymer. The Pinnacle metal on metal hip replacement system with a femoral head, particularly the one that is more than 32 mm, poses a threat of revision surgery. Though the Pinnacle Ultamet does not have as high a failure rate as ASR implants, a large number of incidences of
Biomet Hip Replacement Implant Recall
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Biomet Hip Replacement Implant Recall
Biomet Hip Replacement Implant Recall System
In February 2001, the FDA announced that Biomet, US manufacturer of artificial hips, had made a voluntary recall of its hip replacement system following discovery of defects in the zirconia ceramic femoral heads. The ceramic femoral head components had been produced by the French manufacturer Saint Gobain Desmarquest, which distributes zirconia ceramic femoral heads to the orthopedic industry throughout the world.
Biomet recalled the defective product from the market after it found that the device was vulnerable to fracture at a higher than expected rate, causing failure of the hip implant system within 13 28 months. The recall applies to nine lots of the non implanted ceramic femoral head components, also known as Prozyr® Zirconia Heads, produced from January 1998 to September 1999, when Saint Gobain Desmarquest changed its manufacturing process, especially the heating procedure of the ceramic heads. However, the change is believed to have caused a negative impact on the ceramic femoral head components, which were found to become unstable soon after implantation.
Several other manufacturers of hip implants used this defective component in their hip replacement systems, including DePuy Orthopedics, Stryker Howmedica Osteonics, Encore Orthopedics, Smith & Nephew Inc., Osteoimplant Technology, Apex Surgical, and Zimmer Inc. The batch number of the recalled ceramic femoral head batches has the prefix "TH." The recall only applies to ceramic femoral heads produced since the early 1998. It does not affect any femoral heads made of alumina ceramic.
Following the Biomet recall, all these companies followed suit and withdrewtheir artificial hip replacement systems from the market, saying that the product could fail and fracture, following which the patient would need to undergo a replacement and revision surgery. Even surgeons complain that they find it hard to remove and replace the defective components.
The FDA stated that there were problems with the ball portion of the artificial hip joint, which connects the pelvis and the femoral stem. Reports claim that the ball portion of the artificial hip joint is faulty, which has a propensity to become unstable and thus cause fracture. There are many cases where patients have reported to have heard a popping sound from their hip just before the device fractured, following which they started experiencing excruciating hip and groin pain.
The FDA received a number of reports that the components
Zimmer Durom Hip Replacement Implant Lawsuit
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Zimmer Durom Hip Replacement Implant Lawsuit
Zimmer Durom Hip Replacement Implant
In 2008, Zimmer Holdings suspended sale of Durom Acetabular Cup following numerous complaints of a high implant failure rate. Since 2006, when Durom Cup came to be used in the United States, numerous complaints and lawsuits have been filed against Zimemr Holdings. Most of the lawsuits filed against Zimmer allege that the defendant did not disclose the risks associated with the hip implant cup when it marketed the product. However, Zimmer continues to deny the allegations, precisely blaming the surgeons for the high hip implant failure rate. Many patients have complained that the Durom Cup failed within two years of implantation, as a result of which, they had to bear severe pain and undergo a revision surgery.
Patients complain of pain and stiffness following their hip replacement surgery with Durom Cup. They allege that they experience so much stiffness and sharp pain in the groin that they cannot walk properly. Most of the patients also allege that they even find it difficult to come down the stairs.
Zimmer Durom Cup Dangers
The Durom Cup had been implanted in more than 12,000 patients in the country from 2006 to 2008. According to reports, about 11 percent of the Durom Cup implants failed in the first two years. However, Zimmer claims that the product can last for 15 years, saying that the metal hip replacement system is far more durable than traditional implants.
In fact, the Durom Cup is a metal-on-metal hip replacement system, with multiple metal components designed to fit into a “ball and socket” formation. As the ball rotates and rubs against the cup-like socket, it sometimes presses against the edge of the cup, thus generating a large volume of microscopic metal shavings into the patient’s bloodstream. The metallic debris can be absorbed by the soft tissue, resulting in