Orthopedic Alerts for Patients - Implant Recalls

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

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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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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Johnson & Johnson received its third trial loss in a row over claims its talc powder can cause ovarian cancer after a St. Louis jury recently awarded nearly $70 million to a cancer patient. In a 9-3 vote, the jury awarded compensatory and punitive damages to 63-year-old Deborah Giannecchini, who said J&J’s talc powder caused her Stage IV ovarian cancer.

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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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A study found people who lost weight with the Type 2 diabetes drug Invokana (canagliflozin) got hungrier and ate more, leading to a weight loss plateau. The study conducted by David Polidori and colleagues will publish in Obesity during Obesity Week 2016, which runs from Oct. 13 to Nov.

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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 created a program that allows medical device makers to hide adverse events and report them years later, the Star Tribune reported. Doctors and patients should be able to use this data to make informed decisions about treatment options, but companies like Johnson & Johnson, Stryker and Zimmer routinely reported adverse events late, summarized findings or hid them from the public. The Star Tribune’s report uncovered hundreds of thousands of such incidents.

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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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After critics accused Johnson & Johnson and Bayer of hiding data in clinical trials for their blockbuster blood thinner Xarelto (rivaroxaban), the U.S. Food and Drug Administration said the drug is safe and effective. Since its approval in 2011, Xarelto has made billions for J&J and Bayer. On Oct. 11, 2016, the FDA released its reanalysis of the ROCKET AF clinical trial data — the original trial used to approve Xarelto.

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