Orthopedic Alerts for Patients - Implant Recalls

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

A Texas jury has ordered pharmaceutical giant Johnson & Johnson to pay over $1 billion to six plaintiffs who said the implant maker hid flaws in its hip implants. A federal jury in Dallas on December 1 concluded that J&J’s DePuy Orthopaedics unit knew about the risk that its Pinnacle hip implants would fail but did not warn patients or doctors. According to plaintiffs, metal debris from the Pinnacle metal-on-metal hips entered the bloodstream and caused a number of complications that led to implant failure.

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The U.S. Food and Drug Administration (FDA) has received reports of acute pancreatitis linked to SGLT2 inhibitor Type 2 diabetes medications, the agency announced on its website. The FDA said it was “evaluating the need for regulatory action” for acute pancreatitis in the SGLT2 inhibitor class of drugs. The statement was included in the Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS) list from April to June 2016. “The appearance of a drug on this list does not mean that FDA has concluded that the drug has the listed risk,” the FDA said on its website.

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Taking acid-reducing drugs called proton pump inhibitors and an antibiotic together may increase the risk for life-threatening irregular heartbeat, according to a study. Researchers from Columbia University Medical Center and the Data Science Institute at Columbia University found the popular PPI heartburn drug lansoprazole — known by the brand name Prevacid — and an antibiotic ceftriaxone could increase the risk for a dangerous condition known as long QT syndrome when taken together. The syndrome can cause abnormal heart rhythms, which can lead to death.

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UK-based medical device company Smith & Nephew announced a recall of its Modular SMF and Modular Redapt hip implants after it received reports of complaints and adverse events. Smith & Nephew issued an Urgent Field Safety Notice on November 15, 2016 to its customers with a list of affected lots and products. The company “initiated a voluntary market removal for all lots of modular neck hip prostheses due to a higher than anticipated complaint and adverse event trend,” according to the notice.

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Families who filed lawsuits against GlaxoSmithKline say a new label for Zofran (ondansetron) shows the drugmaker could have warned about birth-defect risks sooner. The new label links the anti-nausea drug to cardiovascular and cleft-palate birth defects for the first time. The previous label didn’t include warnings about those possible side effects because, according to GSK, the language wasn’t approved by the U.S. Food and Drug Administration (FDA), Law 360 is reporting. The FDA only approved the drug to treat nausea and vomiting in chemotherapy, radiation and surgery patients.

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Federal judges have consolidated dozens of lawsuits alleging the blockbuster antipsychotic drug Abilify (aripiprazole) caused compulsive gambling, sex addiction and other disorders. U.S. District Judge M. Casey Rodgers will preside over about 43 compulsive-behavior lawsuits in multi-district litigation in the Pensacola-based Northern District of Florida. Plaintiffs allege the drug’s makers, Bristol-Myers Squibb and Otsuka Pharmaceuticals, failed to properly warn patients about the drug’s possible side effects, including binge eating, compulsive gambling and sex addiction. The Judicial Panel on Multidistrict Litigation issued the order to consolidate cases on Oct.

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The U.S. Food and Drug Administration released its final guidelines on the controversial Essure Permanent Birth Control System, and women injured by the device say the agency failed them. “The guidance includes a ‘suggested’ black-box warning along with a patient decision checklist,” the support group Essure Problems — a Facebook group with more than 30,000 members — said in a statement. “Once again, we find that the FDA has done a pitifully insufficient job.” The Essure Birth Control System hit the market in 2006.

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The U.S. Food and Drug Administration has approved a new surgical tool for use in certain gynecological procedures, the device’s maker, Olympus America Inc., announced Wednesday. The PK Morcellator is an electrical device intended for cutting and removing tissue in laparoscopic — or minimally invasive — gynecological procedures, according to the FDA. Power morcellators have been a source of controversy since 2014 when the FDA announced their use during surgery could spread lethal cancer in the body.

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People who use proton pump inhibitors (PPIs) to control stomach acid are more likely to end up in the hospital with infectious gastroenteritis, also known as stomach flu, researchers found. Doctors prescribe PPIs like Nexium (esomeprazole) and Prilosec (omeprazole) to treat chronic heartburn and gastroesophageal reflux disease (GERD), two conditions caused by too much stomach acid. PPIs are some of the most frequently prescribed drugs in the world.

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