Counterfeit Medical Devices

The World Health Organization warns that 8% of the medical devices in use arecounterfeit. In fact, the WHO has even created a branch to protect the public from such devices. It is called the International Medical Products Anti-Counterfeiting Taskforce (IMPACT). Counterfeit medical devises and products pose a threat to patient health. They can cause infection (such as bandages that are not sterile) or injury, produce fallacious test results, and possibly death.

One example of this was the 2010 recall of counterfeit surgical mesh. Surgical mesh is a woven fabric used in strengthening tissues in various procedures such as trauma wounds or internal organs. It is implanted in the body during surgery for a variety of reasons that I will not go into here. Unfortunately, a brand name surgical mesh was counterfeited and sold under the company name, and had to be recalled. We are fortunate this was caught and the FDA is now implementing regulations that would place requirements on manufacturers so that legitimate products can easily be traced by putting unique identifiers on each of the products. This is much the same as the hologram film on the BOTOX® vial label that Allergen uses.

What does this have to do with cosmetic surgery? You might recall the PIP breast implant recall in Europe last year. Some of the implants were made from non surgical grade silicone, others reportedly had very high rupture rates. Three-quarters of the women who had their implants removed claimed they had to contact their surgeon themselves. This inability to track patients would be avoided, in the United States, with the new FDA regulations. PIP implants were never used in the United States. Now imagine if the liposuction device used was not manufactured properly. It could cause severe damage. A very recent example of this is the discovery of a counterfeit CoolSculpting® device in use in several practices. A recent press release we came across explains how these devices often do not have the safety features of  the legitimate devices created by the manufacturer. We do not use CoolSculpting® at Little Rock Cosmetic Surgery Center, so not to worry. But it is instances like this that should encourage patients to research their cosmetic surgeons thoroughly, and surgeons to be on their guard when purchasing medical devices. At Little Rock Cosmetic Surgery Center we only purchase medical devices and products from legal brand name manufacturers.

The way to protect yourself from having a dangerous experience of counterfeit medical devices or products, is to research and choose a board certified cosmetic surgeon. Be aware that new, trendy procedures lend themselves to such counterfeit devices more than tried and true methods used in cosmetic surgery because the FDA has not had time to study the device. If you hear of a deal too good to be true, it probably is, and it is quite possible that the provider is using cheaper, counterfeit products. Of course even here at Little Rock Cosmetic Surgery Center we sometimes offer specials. The difference is that unscrupulous providers, who may not be certified, or have simply not done their research on the products can be intentionally or inadvertently using them. As a board certified cosmetic surgeon, I am very conscientious about researching the products used at Little Rock Cosmetic Surgery Center. Liposuction machines, implants, and all other devices and drugs are safe, sterile, and bought directly from the manufacturers and kept in tip top condition!

Dr. Branman

Call Melinda, my Patient/Surgery Coordinator to set up your consultation. 501 227-0707

Thanks to Charlotte90T for the great stethoscope picture!