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metal-on-metal hip 48 articles

Netflix documentary reveals dangers of medical devices

The Netflix documentary The Bleeding Edge, directed by Kirby Dick, casts a dim light on the $400 billion-dollar medical device industry and the regulatory agency charged with protecting consumers against dangerous drugs and medical devices. The documentary focuses on several people who received or were treated with a medical device – from vital devices like hip implants and blood clot catchers to elective ones like breasts implants and contraceptive devices. These patients trusted their devices were safe, but later found the products were never tested for safety and efficacy, learning they were essentially guinea pigs. One patient is an orthopedic ... Read More

Metal-on-metal Hip Recipients Experience Adverse Soft-Tissue Reaction to Metal Debris, Study shows

In a study at Coxa Hospital for Joint Replacement in Finland, researchers assessed 176 patients who received metal-on-metal hip implants (203 hips) and found that 84 of those hips required revision surgery. In 87 percent of these revisions, adverse soft-tissue reaction to metal debris (ARMD) was diagnosed. Additionally, a larger femoral diameter and stem type had a higher risk of ARMD, metallosis, and device failure. Metal-on-metal hip designs, made by a number of medical device manufacturers such as Wright Medical, DePuy Orthopaedics and its parent company Johnson & Johnson, Stryker, Smith & Nephew and Zimmer Biomet Holdings, are made up of a cobalt-chromium alloy, which has been ... Read More

Plaintiffs Push to Consolidate Smith & Nephew Metal-on-Metal Hip claims in MDL

On Feb. 1, plaintiffs filed a petition asking the Judicial Panel on Multidistrict Litigation (JPML) to consider consolidating complaints against Smith & Nephew over its Birmingham Hip Resurfacing (BHR) and R3 Acetabular System devices. As many as 31 cases are still pending in 22 federal district courts, according to the petition, and dozens more are expected to flood in. Pretrial coordination before a single judge in Maryland would facilitate resolution of the claims, the plaintiffs say. In June of 2012, Smith & Nephew recalled its R3 Acetabular System, an optional metal liner component used in hip implant devices. This includes about 7,700 metal liners that ... Read More

Metal-on-metal hip implant settlement cuts Into Stryker Earnings

Profits for Stryker, a medical device manufacturing giant, have taken a 2.3 percent cut year-over-year when projections had predicted they’d be up by 14.1 percent. This is likely due to the number of lawsuits regarding the company’s Rejuvenate or ABG II modular metal-on-metal neck hip stems. Information about the earnings came about a month after Stryker announced that Howmedica Osteonics, its subsidiary, had reached a settlement with patients who required revision surgery to correct problems with their new Rejuvenate or ABG II metal-on-metal hips. The metal-on-metal hip implant designs, made by a number of medical device manufacturers such as Wright Medical, DePuy Orthopaedics and its parent company Johnson & Johnson; Smith & Nephew, and Zimmer Biomet ... Read More

Indiana man claims DePuy Orthopaedics metal-on-metal hip implant is the source of ‘constant debilitating pain’

Just four days after a Texas jury awarded six plaintiffs a $1 billion verdict against DePuy Orthopaedics and its parent company, Johnson & Johnson related to the company’s metal-on-metal hip implant, a new lawsuit is filed about a similar case. An Indiana man filed a lawsuit against DePuy, the maker of his metal-on-metal hip implant, saying it caused him “constant debilitating pain and instability” because of the “friction wear from the movement at the joint.” He received the hip implant in 2008, but was forced to have revision surgery just six years later to fix the agonizing problems. The metal-on-metal implants have been ... Read More

FDA Panel Says Metal-on-Metal Hip Implants are not recommended for Most Patients

The U.S. Food and Drug Administration (FDA) panel of medical device experts convened recently, advising against metal-on-metal hip implants, just short of banning the device altogether. The panel also advised that any patients who have received the devices should be evaluated with an X-ray and blood tests, particularly if they are experiencing pain or other symptoms that might indicate device failure. In particular, blood tests would allow detection of metal in the bloodstream, which could result in metallosis, a dangerous condition of metal poisoning in the blood. The metal-on-metal hip designs, made by a number of medical device manufacturers such as Wright Medical, ... Read More

European Medical Device Regulations Tightened Due to Metal-on-Metal Hip Implant Safety Concerns

New medical device regulations (MDR) have been put in place by European Parliament after four years of negotiation. The decision to tighten regulation was spurred by safety concerns over breast implants and metal-on-metal hips. The regulation amendments are expected to begin in early 2017, and medtechs will be allowed three years to comply. If the medical products fail to meet the new regulation standards, the manufacturer will lose their CE rating, which allows legal marketing of the product. The new regulations include stricter rules regarding clinical trials, quality management, and marketing necessities such as product labeling and design. Regulators will now inspect Class ... Read More

Wright Medical Agrees to $240 Million Settlement Over Metal-on-Metal Hip Injury Claims

Wright Medical Group, a medical device manufacturing company based in Amsterdam, Netherlands, has entered into a settlement over litigation involving its metal-on-metal hip implants. The litigation included 1,292 claims that the company’s Conserve, Dynasty or Lineage hip implants resulted in revision surgeries. Wright also estimates that about 600 cases won’t be included in the settlement, and has stated that it will “vigorously defend” those that weren’t settled. The settlement is for an eye-popping $240 million – $60 million going to insurance recoveries, and $180 million to be paid in cash. Robert Palmisano, Wright’s own CEO, said he was glad to reach the settlement so that the company ... Read More

Johnson & Johnson, DePuy Slapped with $1 billion Verdict in Metal-on-Metal Hip Implant Trial

In a two-month trial that ended on November 30th, the jury has found Johnson & Johnson and its subsidiary, DePuy Orthopaedics, liable for more than $1.04 billion due to their hip implant systems that shed metal debris. The six-plaintiff bellwether trial verdict comes mere months after a jury ruled in favor of plaintiffs in a $500 million verdict, which was ultimately reduced to $150 million under a Texas legal punitive damages cap. This time, however, the trial is under California law, not subject to the same cap. Jurors deliberated for less than a day before finding J&J and DePuy liable for negligent design ... Read More

Cobalt Toxicity is a Serious Risk for Metal-on-Metal Hip Patients

When Robert Peters wrote the Daily Mail for advice from Dr. Scurr about concerns with his metal-on-metal hip implants, the response seemed to only confirm his greatest fears – that his hip implants could be poisoning him. Peters’ blood was tested after his surgeon informed him of the recent reports of metal-on-metal hip failures. “Blood tests revealed I have 100 times more than normal the amount of cobalt in my blood,” Peters wrote, “as well as dangerous amounts of chromium.” Dr. Scurr explained that metal-on-metal hips are usually made of a stainless steel alloy containing cobalt and chromium, and were intended to ... Read More