An integrated benefit-risk assessment of cobalt-containing alloys used in medical devices: Implications for regulatory requirements in the European Union.

In 2017, the European Union (EU) Committee for Risk Assessment (RAC) recommended the classification of metallic cobalt (Co) as Category 1B with respect to its carcinogenic and reproductive hazard potential and Category 2 for mutagenicity but did not evaluate the relevance of these classifications for patients exposed to Co-containing alloys (CoCA) used in medical devices. CoCA are inherently different materials from Co metal from a toxicological perspective and thus require a separate assessment. CoCA are biocompatible materials with a unique combination of properties including strength, durability, and a long history of safe use that make them uniquely suited for use in a wide-range of medical devices.

A hazard evaluation of the reproductive/developmental toxicity of cobalt in medical devices.

Cobalt (Co) is an essential element with human exposure occurring from the diet, supplement ingestion, occupational sources, and medical devices. The European Chemical Agency (ECHA) recently voted to classify Co metal as a Reproductive Hazard Category 1B; presumed human reproductive toxicant due to adverse testicular effects in male rodents. A weight of evidence evaluation of the preclinical reproductive and developmental toxicity studies and available clinical data was performed to critically evaluate the relevance of this proposed classification for Co in medical devices.

Carcinogenic hazard assessment of cobalt-containing alloys in medical devices: Review of in vivo studies.

Cobalt (Co) alloys have been used for over seven decades in a wide range of medical devices, including, but not limited to, hip and knee implants, surgical tools, and vascular stents, due to their favorable biocompatibility, durability, and mechanical properties. A recent regulatory hazard classification review by the European Chemicals Agency (ECHA) resulted in the classification of metallic Co as a Class 1B Carcinogen (presumed to have carcinogenic potential for humans), primarily based on inhalation rodent carcinogenicity studies with pure metallic Co. The ECHA review did not specifically consider the carcinogenicity hazard potential of forms or routes of Co that are relevant for medical devices.

Hypertonic Sodium Chloride Preinjectate Increases In Vivo Radiofrequency Ablation Size: Histological and Magnetic Resonance Imaging Findings.

Background And Objectives: Emphasis has been placed on methods to enlarge monopolar radiofrequency (RF) lesion size for pain management. Ex vivo research has suggested that fluid modulation may be an effective method to enlarge lesion zone. To date, these findings have not been confirmed in vivo.

Sustained analgesic effect of clonidine co-polymer depot in a porcine incisional pain model.

Background: Previous research suggests that the α adrenergic agonist clonidine, a centrally acting analgesic and antihypertensive, may also have direct effects on peripheral pain generators. However, aqueous injections are limited by rapid systemic absorption leading to off target effects and a brief analgesic duration of action.

Purpose: The aim of this study was to examine the efficacy of a sustained-release clonidine depot, placed in the wound bed, in a pig incisional pain model.

Tissue distribution of clonidine following intraforaminal implantation of biodegradable pellets: potential alternative to epidural steroid for radiculopathy.

Background: Epidural steroid injections have shown efficacy in short-term pain relief, but often require repeated injections in order to provide continued pain relief. It has been suggested that a continuous, locally administered dose of an anti-inflammatory compound may provide sustained pain relief at doses lower than those needed with injections.

Objective: To evaluate the distribution of clonidine after transforaminal placement of a biodegradable drug delivery depot system.

Differences between neurosurgeons and orthopedic surgeons in classifying cervical dislocation injuries and making assessment and treatment decisions: a multicenter reliability study.

Variability exists in the management of cervical spinal injuries. The goal of this study was to assess the effect of training specialty (orthopedic surgery vs neurosurgery) on management of cervical dislocations. Twenty-nine spine surgeons reviewed 10 cases of cervical dislocation injuries.

Mean subaxial space available for the cord index as a novel method of measuring cervical spine geometry to predict the chronic stinger syndrome in American football players.

Object: The chronic stinger syndrome is a distinct entity from acute stingers and has been shown to have its own pathophysiology that, unlike acute stingers, may reflect long-standing geometrical changes of the subaxial spinal canal and chronic irritation/degeneration of the exiting nerve root complex. There is no method available, however, to accurately predict these symptoms in athletes. The mean subaxial cervical space available for the cord (MSCSAC) is a novel alternative to the Torg ratio for predicting neurological symptoms caused by cervical spondylosis in elite athletes.

Intrarater and interrater reliability and validity in the assessment of the mechanism of injury and integrity of the posterior ligamentous complex: a novel injury severity scoring system for thoracolumbar injuries. Invited submission from the Joint Section Meeting On Disorders of the Spine and Peripheral Nerves, March 2005.

Object: A new classification and treatment algorithm for thoracolumbar injuries was recently introduced by Vaccaro and colleagues in 2005. A thoracolumbar injury severity scale (TLISS) was proposed for grading and guiding treatment for these injuries. The scale is based on the following: 1) the mechanism of injury; 2) the integrity of the posterior ligamentous complex (PLC); and 3) the patient's neurological status.