Sanofi Genzyme issues voluntary recall of one lot of Synvisc-One syringes
Sanofi Genzyme has issued a voluntary recall of one lot of Synvisc-One ® (hylan G-F20) lot 7RSL021. The product is used to treat arthritis of the knee and the affected lot was distributed between Oct. 25, 2017, and Nov. 7, 2017. The company states that investigational testing revealed the presence of microbial contamination. Providers should immediately discontinue use of Synvisc-One lot number 7RSL021 and should treat any patients exposed to lot 7RSL021 in accordance with standard of care, including potential for Gram-negative infection. The recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
Government funding bill did not include money for CHIP
An article published on the NBC News website notes that a continuing resolution passed by the U.S. Congress and signed into law by President Donald J. Trump will keep the federal government funded until Dec. 22, 2017. The resolution provides no additional funding for the Children’s Health Insurance Program (CHIP), but requires the U.S. Department of Health & Human Services to reallocate any remaining CHIP funds to states with the highest need.
Study: Pharmacomechanical catheter-directed thrombolysis may increase risk of bleeding for patients with acute DVT
According to a study published in the Dec. 7 issue of The New England Journal of Medicine, addition of pharmacomechanical catheter-directed thrombolysis to anticoagulation may not reduce risk of post-thrombotic syndrome for patients with acute proximal deep-vein thrombosis (DVT). The authors conducted a randomized trial of 692 patients with acute DVT who received either anticoagulation alone or anticoagulation plus pharmacomechanical thrombolysis. At minimum 6-month follow-up, they found no significant difference across cohorts in percentage of patients with post-thrombotic syndrome and no significant difference in recurrent venous thromboembolism over a 24-month follow-up period. However, the authors note that patients in the pharmacomechanical thrombolysis were at significantly increased risk of major bleeding events within 10 days.
Data from a rabbit study published online in The American Journal of Sports Medicine suggest that current practice of treating knee ligament injuries with platelet-rich plasma (PRP) may not improve healing at low doses. The researchers conducted a controlled, laboratory study of 80 skeletally mature New Zealand White rabbits (160 knees), in which the medial collateral ligament (MCL) was torn midbody to simulate a grade 3 tear. Compared to a saline-injected control cohort, they found that a single dose of PRP in either 0 million/uL or 0.6 million/uL concentrations was not associated with improved ligament healing. Further, a single dose of PRP at 1.2 million/uL concentration negatively affected ligament strength and histological characteristics at 6-week follow-up.
Study: Data support informing patients of overlapping procedures
Findings from a study conducted in Canada and published online in the journal JAMA Internal Medicine suggest the practice of overlapping surgery may be relatively rare, but notes potential for an increased risk for surgical complication. Members of the research team conducted a retrospective, population-based, cohort study of 38,008 surgically treated hip fractures, of which 960 were considered overlapping, and 52,869 total hip arthroplasties (THAs), of which 1,560 were considered overlapping. After matching, the researchers found that both overlapping hip fracture procedures and THAs were at increased risk of complication compared to non-overlapping procedures “These findings support the notion that overlapping provision of surgery should be part of the informed consent process,” they write.
Recording system assesses surgeon performance in robot-assisted surgeries
A study published online in The Journal of Urology describes a recording system that observes surgeon performance metrics using a robotic surgery system. The device recorded kinematic and events data for 10 experts (mean 810 cases) and 10 novices (mean 35 cases) in 100 robot-assisted radical prostatectomy cases. The researchers found that objective metrics had limited associations to expert reviewers who rated performance using the Global Evaluative Assessment of Robotic Skills, but state that the findings “lay the foundation for developing standardized metrics for surgeon training and assessment.”
AAOS seeks two delegate representatives to join the American Medical Association (AMA) House of Delegates. Members of the AMA House of Delegates serve as an important communications, policy, and membership link between the AMA and grassroots physicians. Applicants for this position must be AAOS active fellows, candidate members, candidate members osteopathic, candidate member applicants for fellowship, or candidate member applicants for fellowship osteopathic who are also AMA members. The application deadline is Dec. 15, 2017.
