Orthopedic Alerts for Patients - Implant Recalls

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

Changes in menstrual bleedingUnwanted pregnancyChronic painPerforation/migration of the deviceAllergy and sensitivity or immune-type reactionsANVISA issued Resolution RE 457, which suspends the importation, distribution, sale, and use of the product throughout the national territory of Brazil. This is a major victory for patient safety and women in Brazil. Essure Not Banned in U.S. However, despite a similar assessment of the device by the U.S. Food and Drug Administration (FDA), Bayer continues to market and sell Essure in the United States. The device works by causing scar tissue to build up in the fallopian tubes to prevent fertilization of eggs. Bayer claims the device is over 99 percent effective at preventing pregnancy.

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By E. Scott Sills, MD, PhD Not every woman with Essure contraceptive implants will have pelvic cramping, bleeding, painful sex, weight gain or other problems appear after this procedure. But, there is no clear consensus on what to do about women with Essure who subsequently develop symptoms associated with this device. It is understandable that symptomatic Essure patients would seek some kind of surgery to treat complications. But, our research unfortunately showed a surprisingly high reliance on hysterectomy to accomplish this. An earlier study looked at outcomes after thousands of Essure procedures in New York, and found the risk of undergoing reoperation was more than 10 times higher for Essure patients, compared to women who had standard laparoscopic tubal ligation.

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Ethicon will defend against claims that its hernia mesh caused serious injuries in a trial slated to begin in 2018, according to court documents. The trial is the first Ethicon will face over its Physiomesh Flexible Composite Mesh. The plaintiff, Matthew Huff, was one of the first to file a lawsuit after Ethicon pulled the hernia mesh from the market in 2016. According to the company, it stopped selling the product because of higher rates of hernia recurrence and re-operation compared to similar products. Ethicon issued a voluntary recall in Europe and other countries, but only a “market withdrawal” in the U.S.

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Popular heartburn drugs called proton pump inhibitors taken by millions of Americans may increase the risk of heart problems, kidney damage and death, according to two 2017 studies. The first study, published in PLoS One by Anna Maria Pello Lazaro and colleagues looked at 706 patients with coronary artery disease (CAD). About 431 of these patients took PPIs, most commonly Prilosec (omeprazole), to control stomach problems from CAD medications. But, patients who took PPIs had a higher risk of heart failure and death that those who did not, about 14.65 percent versus 5.45 percent.

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After its initial $1 billion dollar settlement offer in 2014, Stryker Corporation and Howmedica Osteonics Corp. reached a new agreement to compensate additional hip implant patients, according to a press release. In December 2016, Stryker announced it will “compensate additional eligible U.S. patients who had surgery to replace their Rejuvenate Modular Neck Hip Stem and ABG II Modular Neck Hip Stem, known as a revision surgery, prior to December 19, 2016.” Enrollment for the new program began Jan. 17 and ends March 1, 2017. Stryker requires 95 percent of eligible patients involved in lawsuits to enroll in the 2016 Settlement Program in order to begin paying out benefits.

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The European Medicines Agency (EMA) recommended manufacturers of Invokana (canagliflozin) and other sodium glucose cotransporter 2 (SGLT2) inhibitors add warnings for increased lower-limb amputations to prescribing information. On Feb. 10, 2017, the EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) looked at data from two clinical trials, CANVAS and CANVAS-R, and found an increase in lower limb amputation in patients taking Invokana. The amputations mostly affected the toes, according to the EMA’s announcement. “On the basis of the available data, the PRAC recommends that a warning on the risk of lower limb amputation (mostly affecting the toes) should be included in the prescribing information for these medicines, highlighting the importance of routine preventativfe foot care,” the EMA said in its warning letter.

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A study linked heartburn drugs called proton pump inhibitors — such as Nexium (esomeprazole) and Prilosec (omeprazole) — to increased risk of potentially serious stomach infections. The study published on Jan. 5 in the British Journal of Clinical Pharmacology followed about 565,000 adults in Tayside, Scotland. Dr. Thomas M. MacDonald and colleagues split patients into two groups: Those who used proton pump inhibitors and H2 receptor agonists — another kind of acid blocker — and a control group.

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A government report revealed limitations in the U.S. Food and Drug Administration’s adverse event reporting system led to a 23-year delay in warning the public about serious risks linked to surgical devices called power morcellators. In 2015, the Government Accountability Office began investigating the FDA and power morcellators at the request of Representatives Mike Fitzpatrick and Louise Slaughter and others over concerns the device could spread uterine cancer. The GAO report released on Feb. 7, 2017 found doctors, hospitals and individuals did not properly report morcellator problems to the FDA through its adverse event reporting system, causing a delay in the agency’s action to warn the public.

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More than half of the nearly $5 billion recovered under the federal False Claims Act during the last budget year came from the health care industry. The U.S. Department of Justice secured roughly $4.7 billion in settlements and judgments from civil cases involving fraud and false claims during the budget year that ended Sept. 30. Of that, $2.5 billion came from the health care industry, including drug companies, medical device companies, hospitals, nursing homes, laboratories and physicians.

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