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FDA Advisors to Review Metal-on-Metal Hip Implant Problems in June

The U.S. Food & Drug Administration (FDA) has scheduled an advisory meeting to discuss metal-on-metal hip implants. This, in the midst of increasing concern over the safety of the now-controversial medical devices.

The meeting, a two-day event, said Reuters, will involve an expert review that could lead to the creation of significantly more stringent standards. Scheduled for June 27-28, the panel will include scientists, researchers, patients, and medical practitioners and is meant to assist federal regulators on potential new testing standards and medical device review requirements needed to allow such products to be sold in the United States. (more…)

Zadroga Act Panel Recommends Cancer Coverage

The Zadroga Act panel has recommended cancer coverage for Ground Zero workers who claim they developed various forms of cancer as a result of their work there following the September 11, 2001 terrorist attacks. Until now, the workers have been denied coverage for cancer. The recommended coverage

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is for some cancers, said WNYC. Proposed cancers include cancer of the respiratory, digestive, and urinary systems; different varieties of breast, skin, mouth, ovary, and thyroid cancers; and all or most blood, childhood, and rare cancers. Prostate brain, and pancreatic cancers are excluded. (more…)

Study Links St. Jude Riata Lead to 22 Deaths

A new study has linked St. Jude Riata leads to 22 deaths, according to researchers. St. Jude’s defective Riata defibrillator leads were recalled in December over possible risks of injury or death, leaving the 76,000 Americans implanted with the defective devices patients with difficult options.

Implantable defibrillators are meant to keep the heart beating regularly and to shock the heart back to proper rhythm should the heart stop. The defibrillator lead, a thin wire attached to the heart wall, delivers an electrical impulse by way of the defibrillator. Should the wire perforate the heart wall, the heart can bleed into its pericardial sac, a lethal condition known as cardiac tamponade, in which pressure builds around the heart preventing it from beating effectively. (more…)

New Zealand Reports Spike In DePuy ASR Hip Implant Removal Surgeries

New Zealand is reporting a spike in DePuy ASR hip implant revision surgeries. The DePuy ASR hip device was recalled in 2010. DePuy is a unit of Johnson & Johnson.

The last available data, released in December 2010, indicated that 7% of those patients implanted with the faulty DePuy ASR had to undergo revision. Now, said The New Zealand Herald (NZ Herald), the number has jumped to 23%, according to hip registry figures on the conventional total hip. (more…)

Study Reports High Level of Metal Ions in Metal-On-Metal Hip Implant Patients at 5-Year Follow-Up

A new study reveals high levels of metal ions in patients implanted with metal-on-metal hip implants. While the metal ion levels steadied in patients implanted with 28-mm metal-on-metal hip bearings, the levels continued to increase for 36-mm metal-on-metal bearings at the five-year mark, said Ortho SuperSite.

“This was a prospective randomized trial with three arms: A 28-mm polyethylene liner, 28-mm metal-on-metal (MoM), and a 36-mm [MoM],” said C. Anderson Engh Jr., MD, who was speaking at the American Academy of Orthopaedic Surgeons 2012 Annual Meeting, in San Francisco. “The same stem and cup were utilized. We looked at serum, erythrocyte and, at 5 years, whole blood ion levels,” he added, wrote Ortho SuperSite. (more…)

Report Questions Timing of DePuy ASR Hip Implant Phase-Out

Although DePuy Orthopaedics has long claimed it phased out its controversial ASR hip implant devices over declining sales, a breaking The New York Times report says the device maker chose to phase out the ASR only following a U.S. Food and Drug Administration (FDA) request.

The agency sent a so-called “Nonapprovable Letter” to DePuy, a division of Johnson & Johnson, citing the “high concentration of metal ions” in the blood tests of some patients implanted with its metal-on-metal hip implant, said The Times. The Times obtained the FDA letter under the Freedom of Information Act. At the same time, reports were being received that indicated the implant was performing “somewhat more poorly” than data submitted by DePuy, The Times wrote, citing the FDA letter. As a matter-of-fact, said The Times, Australian data revealed that by mid-2009, the device was failing prematurely and at high rates.

The nonapprovable letter was sent confidentially to DePuy in 2009 and indicated it was rejecting DePuy’s application to sell the all-metal device in the U.S. The letter, in large part, dealt with issues that FDA reviewers had with DePuy’s study data, said The Times, and asked DePuy for additional safety data in order for the application to be pursued.

At that time, DePuy was already marketing another version of the device, the ASR XL Acetabular Hip Implant, in the U.S.Neither device was recalled until August 2010, a full year after the FDA letter.

In the meantime, said The Times, in September 2009, DePuy officials implemented a strategy to phase out both devices, although remaining stock continued to be used in patients worldwide, according to DePuy records.

The recalled DePuy ASR XL Acetabular System and ASR Hip Resurfacing System are both metal-on-metal implants, originally believed to offer improvements over prior metal-on-plastic devices. For some time now, health professionals have been concerned with metal-on-metal grinding that would cause shards to shed into patients’ bodies leading to inflammation and joint, nerve, and tissue damage. Experts are concerned that the metal debris could poison organs, increase cancer risks, and even impact the developing fetus.

The number of patients implanted with DePuy’s ASR hip implants in between September 2009 and the August 2010 recall is not known; however, over an eight yearpeirod, 93,000 patients worldwide—about one-third in the U.S. alone—received the faulty ASR, said The Times.

Irish DePuy ASR Hip Implant Patients Plan Lawsuit

A group of Irish DePuy ASR hip implant patients are planning a lawsuit over their ongoing health issues related to the faulty medical implants. DePuy is a subsidiary of Johnson & Johnson.

The lawsuit is being filed on behalf of more than 200 patients fitted with defective DePuy hip implants from 2003 to 2010, said TheJournal.ie. The solicitor handling the case is hoping Ireland’s High Court will begin hearing cases in the next 12-18 months. Some 3,500 patients in Ireland have been fitted with the faulty devices, 193 revision surgeries have been completed and another 100 revision surgeries have been scheduled.

TheJournal.ie. pointed out that, last month, The New York Times wrote about a defective DePuy hip marketed in Europe after being rejected by the U.S. Food and Drug Administration (FDA) in 2009. Some 93,000 DePuy devices were sent to Europe and India after clinical trials in the U.S. revealed higher-than-expected failure rates, said TheJournal.ie. Two DePuy devices were recalled in August 2010 in the U.S.

The metal-on-metal devices have been found to shed metal shards into the body, leaving bone, nerves, and tissue damaged and leading to—along with early failure issues—patients being forced to undergo painful and complex revision surgery. In some cases, patients are left with blood poisoning and adverse—some, long-term—health problems.

This site has long reported about the dangers posed by metal-on-metal hip implants, explaining that shedding of microscopic metal shards into the surrounding tissue can cause area reactions that destroy muscle and bone and lead to long-term disability. Some studies reveal that metal ions can leach into the bloodstream, spreading and poisoning organs in the body. Preliminary research, conducted by researchers at the University of Bristol in the U.K., also revealed that patients fitted with all-metal hip implants may be at risk of experiencing genetic changes to the bladder cells, a possible precursor to cancer, and possibly to bladder cancer itself.

The plaintiffs’ attorney also explained that revision surgery is very invasive and more difficult than the original surgery, with patients losing even more muscle, tissue, and bone, and typically walking with an increased limp. Although the DePuy implants have been found to fail prematurely at a rate of 12-13%, some U.K research has found that rate to be much higher, at 50%, said TheJournal.ie.

Whistleblower Claims to Have Made Metal-On-Metal Hip Implant Warning 15 Years Ago

A whistleblower has come forward with shocking claims that he/she made metal-on-metal hip implant warnings as far back as 15 years ago. The “unnamed biomedical engineer” is a medical device designer who worked with a firm that developed and manufactured one of the first hip resurfacing devices.

Along with a number of colleagues, the engineers and designers vocally censured the then-new all-metal design. According to The Daily Mail’s anonymous source, “an averagely bright teenager knows that running metal against metal will cause friction, and sooner or later friction causes wear.” The wear, said the source, leads to debris which cannot be filtered out of the body and can lead to damage. This damage is now being discussed by the Medicines and Healthcare Products Regulatory Agency, said The Daily Mail. Studies have also linked the all-metal devices to increased risks for bladder cancer and the devices are suffering from higher early failure rates versus other types of hip devices. (more…)

Wright Conserve Hip Implant Lawsuits Consolidated In Georgia Federal Court

Wright Conserve hip implant lawsuits are being consolidated in a multidistrict litigation (MDL) in the U.S. District Court for the Northern District of Georgia. The hip devices are metal-on-metal.

Allegations include claims that the Wright Conserve hip implants cause injuries similar to the growing injuries being seen in the DePuy ASR and Pinnacle metal-on-metal hip system, said Injury Board. DePuy is a unit of healthcare giant, Johnson & Johnson. This MDL is just one of three being organized to consolidate pre-trial proceedings for those plaintiffs who have filed law suits over faulty metal hip devices. (more…)

Medtronic Infuse Off-Label Use Can Lead To Disability

Medtronic’s Infuse bone graft product can lead to disability when used off-label, according to an emerging lawsuit. Physicians are free to prescribe medicines and devices off-label should they choose; however, it is illegal for drug and device makers to market any of their products off-label, or for uses not approved by the U.S. Food and Drug Administration (FDA). (more…)

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