On October 28, 2019 a Philadelphia State Court Jury awarded the sum of 33 million dollars to Tracy Reed-Brown in a claim against Rex Medical and Argon Medical Devices. The claim stemmed from the malfunction of the Option Retrievable IVC Filter manufactured by Rex Medical and distributed by Argon Medical Devices. This particular IVC filter … [Read more...]
Canada Makes Clinical Trial Data Public, Will the FDA Follow Suit?
In March 2019 Health Canada announced that it would start making clinical information about the safety and efficacy of drugs and medical devices available to the public after a regulatory decision is made. The agency says that making the data available will allow for independent analysis increasing patient safety. The data released is data that was … [Read more...]
FDA Wants Cancer Warning on Breast Implants
The U.S. Food and Drug Administration (FDA) is proposing labeling changes on breast implants. The agency says that women are not fully informed of the risks before choosing implants, including the risk of cancer, and that the changes would help women make a more informed decision. According to the agency there have been 573 reported cases of … [Read more...]
New Study Looks at Gadolinium Deposition in MS Patients
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...]
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...]
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