A recently published study found that multiple injections of the gadolinium-based contrast agent (GBCA) gadodiamide resulted in gadolinium deposition in the brains of multiple sclerosis (MS) patients who were in the first five years of the disease. Patients who had received more than eight injections showed a tendency to have a higher number of … [Read more...]
About Sandra Dalton
Contaminated Stem Cell Product Injuries
In 2018, 12 patients were hospitalized for infections caused by contaminated ReGen Series stem cell products manufactured by Genetec and distributed by Liveyon. On September 18, 2018, Liveyon initiated a voluntary recall of all Genetec-produced products and no longer uses the manufacturer. E. coli was among the bacteria which caused the infections … [Read more...]
Allergan Textured Breast Implants Linked to Cancer Recalled Worldwide
After the U.S. Food and Drug Administration (FDA) requested that Allergan remove certain models of its textured breast implants from the U.S. market, the company initiated a worldwide recall of its BIOCELL textured breast implants and tissue expanders. Earlier this year, the FDA said the evidence did not warrant banning the implants, but after … [Read more...]
Integra LifeSciences Intracranial Medical Device Recall
In May, 2019, the U.S. Food and Drug Administration (FDA) announced a class I recall of Integra LifeSciences’ LimiTorr Volume Limiting Cerebrospinal Fluid (CSF) Drainage System and its MoniTorr Intracranial Pressure (ICP) External CSF Drainage and Monitoring Systems. A class I recall is the most serious type of recall in which the recalled product … [Read more...]
Xeljanz May Cause Blood Clots and Death According to Safety Study
On February 29, 2019, the U.S. Food and Drug Administration (FDA) issued a safety communication warning the public about an increased risk of blood clots and death in patients with rheumatoid arthritis taking a high dose of Xeljanz (tofacitinib). The warning was prompted by a mandatory post-marketing safety trial of the drug. The trial is still … [Read more...]
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