Intragastric Balloon System – FDA Issues Safety Alert

 

In the United States, an estimated 160 million Americans are overweight or obese, according to the Institute for Health Metrics and Evaluation. The statistics are not only overwhelming but an indication that obesity is a massive, worldwide problem. W Read More »

FDA Raises Concern About Breast Implants and Cancer

 

As of February 1st, 2017, the FDA has received 359 reports of a rare type of breast cancer linked to breast implants. The FDA has confirmed that a malignancy of the immune system associated with breast implants has resulted in 9 deaths. Read More »

FDA Warns Doctors About “Absorb” Dissolving Heart Stent

 

Absorb is a stent made of plastic that is designed to dissolve completely over a three-year period. Recent data from two-year clinical trials reveal a much higher rate of heart problems than initially expected once the stent begins to fully dissipate Read More »

Missouri Jury Sides With Defendant in Complicated Vaginal Mesh Case

 

On February 4, 2016 a Missouri jury returned a 10-2 verdict in favor of transvaginal mesh manufacturers Boston Scientific and C.R. Bard. The lawsuit was brought by Eve Sherrer, a woman who wanted a solution to mild urinary incontinence but instead fo Read More »

Who is Monitoring the Safety of Vaginal Mesh Kits?

 

 If medical device companies are going to use this expedited regulatory process, they should have a greater responsibility to make sure the product they take to market is safe since it did not go through normal safety channels.  Medical dev Read More »

FDA Approval Process Called Into Question for Unsafe Practices

 

The Institute of Medicine (IOM) recently called into question the process by which many medical devices are approved through the FDA. The FDA asked the IOM to review their process for approving “moderate-risk devices” which can inclu Read More »

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