America’s Unsafe Medical Products

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The U.S. Food and Drug Administration (FDA) recently issued two safety alerts related to medical products used in the United States. One extends a recall on a medical device and the other discusses the questionable effectiveness of robotically assisted surgical devices in mastectomy procedures.

Earlier this week, the FDA warned against the use of thermography as a stand-alone diagnostic tool to screen for breast cancer. In a warning letter to a distributor that misbrands its thermography package as a stand-alone screener, the FDA said that there is no valid scientific data showing that thermography devices, either used in conjunction with another device or by itself, “are an effective screening tool for any medical condition.” Mammography, the FDA reiterated, “is the most effective breast cancer screening method and the only method proven to increase the chance of survival through earlier detection.”

The FDA issues safety alerts to provide timely new safety information on human drugs, medical devices, vaccines and other products including biologics, dietary supplements and cosmetics. The alerts are publicly available at the agency’s MedWatch website and contain “actionable information that may impact both treatment and diagnostic choices for healthcare professional and patient.”

The following list includes all MedWatch alerts since the beginning of 2019. There are several types of alerts, including letters to health care providers, warnings to users, drug safety notices and recalls. The 2019 alerts are listed in reverse chronological order, with the most recent listed first. Included are the type of alert and the issue date.

Robotically Assisted Surgical Devices for Mastectomy Procedures
> Issue date: February 28, 2019
> Type of alert: Safety communication

The FDA is informing health care providers and patients that the safety and effectiveness of these devices has not been established either for mastectomy procedures or cancer prevention: “There is limited, preliminary evidence that the use of robotically assisted surgical devices for treatment or prevention of cancers that primarily (breast) or exclusively (cervical) affect women may be associated with diminished long-term survival.”

Physio-Control LIFEPAK 15 Monitors/Defibrillators
> Issue date: February 27, 2019
> Type of alert: Recall

Physio-Control has recalled 8,164 monitor/defibrillators to update the system’s firmware. The device may lock up (blank monitor while power indicators are lighted and no response from the keypad and no device functions). This is a Class I recall, meaning that continued use of these devices may cause serious injury or even death.

Golean Detox Capsules
> Issue date: February 25, 2019
> Type of Alert: Recall

Golean Detox USA voluntarily has issued a recall of all lots of its capsules following an FDA analysis that the capsules are tainted with substances that have been withdrawn by the agency from the U.S. market. The company said it has received no reports of adverse effects related to the recall.

Macleod’s Pharmaceuticals Losartan 100mg/25mg Tablets
> Issue date: February 25, 2019
> Type of Alert: Recall

The company is voluntarily recalling of two types of losartan tablets used to treat hypertension. One lot of losartan potassium and hydrochlorothiazide tablets has been found to have trace amounts of an unexpected carcinogen in tablets manufactured by Hetero Labs. The company has received no reports of adverse events related to this recall.