Dr. D will be the first one to admit, he just does not understand the entire concept behind silicone buttock injections. Unfortunately, this time a recipient of an illegal butt injection died. Since Dr. D is a Ph.D. and not an M.D., the doctor cannot provide medical advice to patients. However, on a professional level, if the readers want to have big backsides, as the doctor has stated on multiple occasions, “eat a jelly donut.” In fact, eat a dozen jelly-filled donuts each day, purchased from your favorite donut shop, and you should begin seeing the results quickly. Now as far back as the old doctor can remember, the only person that ever died eating a jelly donut was the King, (rest-in-peace Elvis). However, risking one’s life to receive an illegal butt injection is something the doctor cannot fathom. People, receiving these types of injections, from individuals of questionable moral character, are proving to be a deadly proposition. From a medical device perspective, the FDA considers these types of silicone injections an adulterated device; and as the doctor’s readers already know, entering an adulterated device into commerce in the United States is always going to end badly for the offending individual or establishment. Chief Jailable Officers (CJO) tend to cringe when they hear the phrase adulterated device during a friendly visit from the agency for a cup of coffee and an inspection. Considering devices companies work hard designing products that will ameliorate(look-it-up) the health of patients; it can be quite unsettling reading about one bad apple whose actions have resulted in a death that could have easily been prevented. Enjoy!

Department of Justice Press Release – Excerpt (March 14, 2017)

“Deanna Roberts has pleaded guilty to four felony counts of possessing, transporting, and ultimately illegally injecting persons with liquid silicone and four felony counts of introducing into interstate commerce liquid silicone, which was an adulterated device. One of the women the defendant injected with liquid silicone died about 36 hours after receiving the injection when the silicone migrated to her lungs, heart, brain, and other organs.

“Roberts admitted that she caused the death of one person by injecting her with liquid silicone, and that she also injected liquid silicone into multiple other people, putting their lives at considerable risk,” said U. S. Attorney John Horn. “Before undergoing any type of medical procedure, patients should ensure they have consulted a licensed medical provider who is qualified to provide care.”

Dr. D’s Pearls of Wisdom

There is no question Ms. Roberts’ actions are unconscionable. However, there is also a need for better public awareness about the risks associated with illegal silicone injections. Unfortunately, common sense can become a fleeting virtue when it comes to one’s self-vanity and the desire to improve one’s personal appearance. Granted, some individuals are blessed with the ability to sell used cars or pass themselves off as being physicians licensed to inject silicone into one’s buttocks. The best advice Dr. D can offer to anyone pursuing a medical procedure, be it cosmetic or life saving: Do your homework! Use the technology available, a.k.a., the Internet, and perform a thorough background check including: (a) the procedure (risk, recover time, & projected patient outcomes); (b) the qualifications of the physician or service provider, and (c) the device(s) used in the procedure. However, if the surgical suite is attached to a mechanical engineering service company and the silicone is also being used to lubricate mechanical parts, you may want to think twice about dropping those undies for a butt injection. Your better option is to walk across the street to the donut shop and start chowing down.

As previously stated, the death mentioned in this article is tragic but clearly preventable. The FDA attempts to do everything within its power to keep adulterated products out of the American medical device market. Unfortunately, unsavory individuals are always going to test the agency’s ability to protect the health of the American population to the limit. As industry professionals, it is up to us to raise that proverbial red flag when questionable or illegal activity occurs within our industry. There is no question the sales and marketing folks are always going to push the limits when it comes to device claims and indications for use, but it is okay to push back. In fact, as quality and regulatory professionals it is our job to push back. When in doubt about a device being misbranded or adulterated, talk to the establishment’s CJO. After all, they are the individuals with the most at stake. No self-respecting CJO wants to spend time in Fort Leavenworth, KS wearing a bright-orange jump suit and shiny-stainless-steel bracelets.

Takeaways

For this weeks’ guidance, there is just one takeaway: Use some common sense. We are blessed working in an industry that provides cutting-edge technology used to save and enhance lives. If you, a family member, or a friend is thinking about a medical procedure, ensure you or they do the homework. Teach your family and friends how to use the Internet to perform their own research. However, if they are contemplating silicone butt injections, splurge on a gift of a dozen jelly donuts, with extra jelly and sugar. In closing, thank you again for joining Dr. D, and I hope you found value (and some humor) in the guidance provided. Until the next installment of DG,  cheers from Dr. D., and best wishes for continued professional success.

Find the fake news: This article is part of the MedTech Intelligence April Fool’s edition. Vote on whether or not this is fake news by taking our poll, which will appear on our homepage on April Fool’s Day.

References

1. Code of Federal Regulation. (April 2016). Title 21 Part 820: Quality system regulation. Washington, D.C.: U.S. Government Printing Office.
2. Code of Federal Regulation. (April 2016). Title 21 Part 803: Medical device reporting. Washington, D.C.: U.S. Government Printing Office.
3. Devine, C. (2011). Devine guidance for complying with the FDA’s quality system   regulation – 21 CFR, Part 820. Charleston, SC: Amazon.
4. Devine, C. (2013). Devine guidance for managing key attributes of a FDA-compliant quality management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon.
5. FDA. (March 2017). Inspections, Compliance, Enforcement, and Criminal Investigations. March 14, 2017: Woman admits to causing the death  of another person by injecting her with liquid silicone. Accessed March 20, 2017. Retrieved from https://www.fda.gov/ICECI/CriminalInvestigations/ucm546857.htm