Orthopedic Alerts for Patients - Implant Recalls

Alerts and implant recalls for patients with orthopedic bone and joint conditions.

A new medical study showed that patients who took opioid painkillers three months after hip replacement surgery were more likely to need revision surgery at one and five years than those who stopped taking the drugs. Experts also worry about an increase in opioid overdoses. Opioids are powerful painkillers that are the equivalent of morphine, such as OxyContin, Percocet and Vicodin — these drugs are also highly addictive.  Maria C.S. Ignacio and colleagues at the University of South Australia found that 42 percent of patients who needed revision surgery were still taking opioids one year after the original hip replacement.

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The U.S. Food and Drug Administration issued a Drug Safety Communication on May 18, 2016 warning that Type 2 diabetes medication Invokana (canagliflozin) could cause an increase in leg and foot amputations. The toes are the most affected. Johnson & Johnson’s Invokana is a popular medication that helps control blood sugar in people with Type 2 diabetes. It also comes in a formula with metformin called Invokamet. The drug belongs to a class of drugs called SGLT2 Inhibitors. These drugs work by passing excess sugar out of the body through urine. In 2015, J&J’s blockbuster drug brought in $1.3 billion — about double what it made in 2014 — according to J&J’s Annual Report.

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Lawyers for patients suing Johnson & Johnson and Bayer over severe bleeding injuries caused by the blockbuster blood thinner Xarelto say the drug makers failed to provide clinical trial data, the New York Times reported. Documents filed in court say a re-analysis conducted by Duke published by the New England Medical Journal of Medicine was missing key information that could have affected clinical trial data comparing Xarelto to warfarin in its 2011 ROCKET-AF study. J&J and Bayer stayed silent and helped deceive editors of the journal, lawyers said. The trial in question compared the safety of Xarelto and warfarin.

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New research suggests that popular heartburn drugs called proton pump inhibitors (PPIs) such as Prevacid (lansoprazole), Prilosec (omeprazole) and Nexium (esomeprazole) may damage arteries leading to an increased risk of heart attack, kidney failure and dementia. In the 2016 study published in Circulation Research, John P. Cooke and colleagues at the Houston Methodist Research Institute exposed endothelial cells — the cells that line the walls of arteries — to Nexium for the clinical equivalent of months or years. They compared the results of those cells to those exposed to another class of heartburn medications called H2 blockers, which includes Zantac (ranitidine).

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After months of deliberation, the U.S. Food and Drug Administration announced it is mandating stronger warnings and more studies for Bayer’s controversial Essure Permanent Birth Control device. The decision ignited a social media firestorm among women who say the device caused them severe, permanent injuries and led to hundreds of fetal deaths. Essure is a permanent birth control device made up of two nickel-titanium coils that doctors implant into a woman’s fallopian tubes. In about 3 months, scar tissue forms, blocking the tubes and preventing eggs from being fertilized. But, tens of thousands of women have spoken out about severe complications linked to the device, including organ perforation, severe pain and ectopic pregnancies.

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In the wake of two multi-million dollar jury verdicts, Johnson & Johnson faces another wave of lawsuits filed by women and surviving members of families who claim the company’s talcum powder caused ovarian cancer. Plaintiff’s attorneys want the drug giant to pull its iconic baby powder and other talcum products from the market. Two juries recently found J&J liable for hiding the risk of ovarian cancer linked to its Johnson’s Baby Powder and Shower-to-Shower products. The first February verdict awarded Jackie Fox’s estate $72 million after she filed a suit in Missouri claiming talcum powder caused ovarian cancer.

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A new study on testosterone gel revealed that the benefits of drugs like AndroGel are more modest than previously thought. Some doctors are still unsure about encouraging widespread use of the drug without more data on long term health risks like heart problems and prostate cancer. Makers of popular gels like AndroGel have been criticized for overhyping the benefits of testosterone replacement drugs and promising increased libido, energy and better mood while downplaying side effects. Results of the study suggest that testosterone gels are not cure-alls for the more than one million men that have been smearing gels on their bodies in recent years.

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A recent study published in the BMJ revealed Johnson & Johnson’s DePuy Pinnacle metal-on-metal hip implants have a high revision surgery rate because of manufacturing problems and high levels of metal particles release into the bloodstream. Dr. David Langton, of University Hospital of North Tees in Stockton, UK, and fellow researchers initiated the study. “Although the use of MoM hip devices has declined dramatically in the past five years, hundreds of thousands remain in situ, with the long-term future uncertain,” Langton and colleagues wrote. In the study, researchers identified patients with metal DePuy Pinnacle hips implants. They looked at devices implanted from 2003–2009 and followed up with patients one a year.

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Did you develop cancer after a Hysterectomy? Get a Free Case Review A hysterectomy is a surgery for the removal of a woman’s uterus, also called the womb. This also stops a woman’s menstrual cycle and ability to become pregnant. This surgery is more common in the U.S. than anywhere else in the world. According to the Centers for Disease Control and Prevention, 600,000 women undergo the procedure each year and about 20 million American women have already had it done — making this surgery the second most frequently performed procedure for women in the U.S.

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