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Biomet Hip Replacement Implant Recall

Biomet Hip Replacement Implant Recall System

Biomet Hip Replacement System Implant RecallIn 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 withdrewBiomet Hip Replacement Implant Recall Lawsuittheir 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

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Hip Replacement Recall Lawsuit

Smith & Nephew Birmingham Hip Replacement Recall

Smith Nephew Hip-Implant-LawsuitIn 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 theSmith Nephew Hip Replacement Recall Lawsuit Attorneydevices, 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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Cooper Vision Avaira Toric Contact Lens Lawsuit


contact-lens-eye-injury-lawsuitA 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.

CooperVision-Avaria-toric-largeOn 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.

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Vaginal / Pelvic Mesh Lawsuit


Vaginal / Pelvic Mesh Lawsuit Ethicon Gynecare Recall & Transvaginal Mesh Defects

Vaginal Mesh LawsuitOn June 4, 2012, women health product manufacturer Ethicon, Inc., announced that it would pull out its widely used Gynecare vaginal mesh implants following complaints of serious, life-threatening injuries associated with these products. The recall by the Johnson & Johnson subsidiary included four types of Gynecare mesh implants, TVT Secur, Prolift Pelvic Floor Repair System, Proflit MTM Pelvic Floor Repair System, and Prosima Pelvic Floor Repair System, which are subject to approximately 1,000 lawsuits consolidated under the federal multi-district litigation in Charleston federal court of West Virginia and coordinated litigation at New Jersey state courts.

About 300,000 women in the United States have these trans vaginal mesh devices implanted for pelvic organ prolapse and stress urinary incontinence. The recall was imminent after a FDA health alert in June 2011 expressed concern over a high number of injuries and deaths caused by Gynecare mesh implant side effects and questioned the real benefit of implanting these devices compared to traditional surgeries to treat pelvic prolapsed. The FDA adverse reporting system has received hundreds of complaints of consistent vaginal pain, extrusions, inflammation, bleeding, and other severe and permanent side effects that repeated surgeries failed to cure.

Gynecare Vaginal  / Pelvic Mesh Implants

Vaginal mesh implants were allowed for hernia repairs in the 1950s. The FDA approved Trans Vaginal Mesh Recall Lawsuittheir use in prolapsed surgeries in 2002. However, there were reports of their off-label use by doctors in abdominal surgeries in the 1980s and in vaginal surgeries toward the end of the 1990s. The mesh devices, made of polypropylene plastic, are implanted through pelvic floor surgery to support organs, such as bladder, urethra, uterus, bowel, and top of the vagina, in the pelvis of women against any drop, fall, or prolapse caused by weakening of muscles following pregnancy and other problems. In 2004, vaginal mesh kits were introduced to streamline and standardize the implant procedures. On an average, about 75,000 U.S. women undergo vaginal mesh implants every year.

Ethicon’s Gynecare vaginal mesh implants have almost 70 percent of the market share in the United States. Gynecare TVT mesh implant was approved by the FDA in 1998. However, Johnson & Johnson started selling Gynecare Prolift in 2005 without FDA approval. The manufacturer introduced Gynecare TVT Secur, the first mini-sling procedure, in late 2006. The FDA cleared its Gynecare Prolift+M for transvaginal implant in 2008. According to an estimate by the FDA, about 100,000 vaginal mesh implant operations were performed in the United States in 2010 alone.

FDA Warnings and Side Effect Reports Leading to Vaginal  / Pelvic Mesh Recall

Gynecare vaginal mesh implants have been blamed for a high number of serious health problems in users. The FDA has received more than 1,500 complaints in the past three years claiming complications associated with these mesh implants. The FDA has categorized vaginal mesh implants as "Class II" medical device that can cause intermediate risk of harm in patients using it.

In 2008, the federal drug regulator notified the public about potential serious complications in patients caused by vaginal mesh implants. It listed urinary problem, pain, infection, and bladder perforations as key side effects of these products. The MedWatch alert also reported prolapse recurrence in patients implanted with these devices, which required additional surgeries.

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Vaginal Mesh Implant Lawsuit Johnson & Johnson Recall Vaginal Mesh Lawsuit


Mesh Devices Made By Johnson & Johnson Recalled Amid Vaginal Mesh Lawsuit

Drug and device manufacturer Johnson & Johnson subsidiary Ethicon has informed a Gynecare Vaginal Mesh Implant Recall Lawsuitfederal judge in West Virginia that it intends to discontinue sales of its vaginal mesh implant devices as a result of hundreds of vaginal mesh lawsuits being filed by women across the country.

In a letter filed with District Judge Joseph Goodwin , Johnson & Johnson indicated that a request had already been sent to the FDA requesting that the company be allowed to stop commercializing the vaginal mesh devices amid recalls and lawsuits related to the mesh devices in question. A spokesperson also stated that Johnson & Johnson would discontinue sales of the Gynecare mesh devices worldwide.

As previously reported on , the FDA has disclosed that Johnson & Johnson / Ethicon had initialy sold the Gynecare Prolift Mesh Implant for at least 3 years without first obtaing proper FDA regulatory approval.

In January 2012 the FDA ordered Johnson & Johnson and 30 other vaginal mesh implant makers to study potential organ damage and other health complications reportedly associated with vaginal mesh implant surgeries.

Vaginal Mesh Lawsuit

Hundreds of women say the meshes have eroded and shrank over time, causing pain and injuries, after the devices were threaded into place through vaginal incisions. Patients have filed suits against J&J, C.R. Bard Inc. (BCR) (BCR) of Murray Hill, New Jersey; and Endo Pharmaceuticals Holdings Inc. (ENDP) (ENDP) of Chadds Ford, Pennsylvania, along with other manufacturers.

“We are happy to see that Ethicon finally decided to do the right thing and stop selling these products,” Bryan Aylstock, a Pensacola, Florida-based lawyer for mesh patients who are suing J&J, said in a telephone interview.

Ethicon is discontinuing sales of the products worldwide, Matthew Johnson, a company spokesman, said in an e-mail. It’s not recalling meshes already sold or implanted and its decision isn’t based on any safety concerns, he said.

“We came to this decision after carefully considering numerous factors” including “the commercial viability of these products in competitive and declining worldwide markets, the complexities of the regulatory environments in which we operate, and the availability of other treatment options for women,” Johnson said.

Vaginal Mesh Safety and Efficacy

“We continue to have confidence in the safety and efficacy of these products,” he said.

Sales will be ended on a region-by-region basis, with the entire process to be completed by the first quarter of 2013, Johnson said. The Gynemesh will remain on the market only for abdominal implantations, he said.

An FDA spokeswoman, Erica Jefferson, said in an e-mail that she couldn’t comment on Johnson & Johnson (JNJ) (JNJ)’s plan regarding the vaginal mesh implants.

An agency report last year found a fivefold jump in deaths, injuries or malfunctions tied to vaginal mesh for organs that slump, or “prolapse,” because of weakened support. Two months later, an advisory panel urged the FDA to reclassify the devices as “high-risk” products needing human testing.

Prolift Vaginal Mesh Approval

Ethicon introduced one such mesh, the Gynecare Prolift, in March 2005, touting it in an annual report as an “innovative and effective surgical option” for weakened muscles. The FDA said it learned of the Prolift only in 2007, when J&J sought approval for a related product.

The company, the world’s second-biggest health-care products maker, said it could market the Prolift without approval because it was so similar to the already approved Gynecare Gynemesh, Morgan Liscinsky, an FDA spokeswoman, said in March. “FDA disagreed with this assertion,” concluding distribution began “without appropriate” clearance, she said.

The FDA cleared the Prolift in May 2008.

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