Physicians warned about counterfeit medical devices

July 24, 2014
Physicians warned about counterfeit medical devices
Physicians should be aware of the prevalence and serious consequences associated with use of counterfeit medical devices, according to a letter to the editor published online July 20 in Lasers in Surgery and Medicine.

(HealthDay)—Physicians should be aware of the prevalence and serious consequences associated with use of counterfeit medical devices, according to a letter to the editor published online July 20 in Lasers in Surgery and Medicine.

Brian S. Biesman, M.D., from the Nashville Center for Laser and Facial Surgery in Tennessee, and Neelam Patel, from the Vanderbilt University School of Medicine in Nashville, discuss the prevalence and dangers of counterfeit medical devices, many of which target legitimate devices manufactured by Zeitiq and Ulthera.

The researchers note that both companies' devices are protected by patents and have integrated safety features. However, the counterfeit devices are not certified as safe, reliable, or reproducible, and numerous injuries have been documented with their use. There may be economic incentives for purchasing counterfeit devices, but these are outweighed by the risks and liabilities associated with using counterfeit technology. Medical malpractice insurance carriers may not provide coverage for litigation arising from use of non-U.S. Food and Drug Administration-approved devices. There are currently 29 imitations of the Zeltiq device and at least five counterfeit Ulthera devices. Despite being unregulated and unapproved, these can be purchased via the Internet and some are displayed at legitimate trade shows.

"Physicians should be aware of the existence and prevalence of counterfeit and need to understand that use of these devices in the United States can lead to severe economic, civil, and criminal penalties," the authors write.

One author disclosed financial ties to Zeltiq and Ulthera.

Explore further: FDA warns doctors of counterfeit Botox

More information: Full Text

Related Stories

FDA warns doctors of counterfeit Botox

December 24, 2012
Federal regulators have warned more than 350 medical practices that Botox they may have received from a Canadian supplier is unapproved and could be counterfeit or unsafe.

Roche warns of counterfeit cancer drug in US

February 14, 2012
(AP) -- The maker of the best-selling cancer drug Avastin is warning doctors and patients about counterfeit vials of the product distributed in the U.S.

FDA: Purveyors of phony botox targeting U.S. practices

April 29, 2013
(HealthDay)—Medical practices that purchase Botox may unwittingly be purchasing a fraudulent product not approved by the U.S. Food and Drug Administration for sale in the United States, according to an April 26 drug safety ...

Fake Avastin contained several chemicals, no drug

February 28, 2012
(AP) -- Counterfeit versions of the popular cancer drug Avastin obtained by European regulators contain a variety of chemicals, but not the active ingredient found in the genuine drug, according to drugmaker Roche.

Fake drug sales are increasing on the Internet and turning up in legitimate supply chains

February 22, 2012
Criminal gangs are increasingly using the internet to market life-threatening counterfeit medicines and some have even turned up in legitimate outlets such as pharmacies, according to a review led by Dr Graham Jackson, editor ...

Recommended for you

FDA bans use of opioid-containing cough meds by kids

January 12, 2018
(HealthDay)—Trying to put a dent in the ongoing opioid addiction crisis, the U.S. Food and Drug Administration on Thursday slapped strict new restrictions on the use of opioid-containing cold and cough products by kids.

Taking ibuprofen for long periods found to alter human testicular physiology

January 9, 2018
A team of researchers from Denmark and France has found that taking regular doses of the pain reliever ibuprofen over a long period of time can lead to a disorder in men called compensated hypogonadism. In their paper published ...

Nearly one-third of Canadians have used opioids: study

January 9, 2018
Nearly one in three Canadians (29 percent) have used "some form of opioids" in the past five years, according to data released Tuesday as widespread fentanyl overdoses continue to kill.

Growing opioid epidemic forcing more children into foster care

January 8, 2018
The opioid epidemic has become so severe it's considered a national public health emergency. Addiction to prescription painkillers, such as oxycodone and morphine, has contributed to a dramatic rise in overdose deaths and ...

Price tag on gene therapy for rare form of blindness: $850K

January 3, 2018
A first-of-its kind genetic treatment for blindness will cost $850,000 per patient, making it one of the most expensive medicines in the world and raising questions about the affordability of a coming wave of similar gene-targeting ...

Restasis: Why US consumers paid billions for drug deemed ineffective in other countries

January 2, 2018
Why are Americans, both as patients and taxpayers, paying billions of dollars for a drug whose efficacy is so questionable that it's not approved in the European Union, Australia or New Zealand? Restasis, a blockbuster drug ...

0 comments

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.