My dear readers, about a year ago Dr. D wrote a story pertaining to a few bad medtech industry apples being punished by a federal judge for their part in posing as doctors and injecting unwitting patients in their buttocks with industrial grade silicone. Unfortunately, the two individuals mentioned in this week’s Devine Guidance (DG) probably did not have an opportunity to read the doctor’s fine prose and learn about the perils associated with illegal butt injections. For those folks in South Florida wanting to enhance the size of their backsides, there is definitely an easier way. In fact, you can call it Dr. D’s three-step program. Step One: Stop exercising. Step Two: Start consuming mass quantities of jelly-filled donuts. In fact, start consuming mass quantities of everything. Step Three: Repeat steps one and two with a vengeance. Although the doctor cannot guarantee the results, he is pretty darn sure the backsides along with every other part of the body will start to grow. As you read this week’s guidance please keep in mind that the two individuals mentioned in the Department of Justice Press Release have only been arrested and indicted and are presumed to be innocent until their cases are adjudicated (look-it-up) in the federal courts.
Department of Justice Press Release – Excerpt
“Jimenez and Del Rosario are charged with conspiring, from 2008 through August 2015, to receive and deliver an adulterated and misbranded medical device in connection with their unlawful receipt and use of silicone smuggled into the U.S. from Colombia and eventually injected into hundreds of clients seeking augmentation of their buttocks, as well as their administration of injections of misbranded prescription drugs, including lidocaine and Botox, at Bella Beauty Spa (“Bella Beauty”), a business owned by Jimenez, located at 8360 West Flagler Street, Miami, Florida (Count 1). The defendants are also charged with conspiring to commit wire and mail fraud arising from their fraudulent misrepresentations to these same clients regarding the true nature of the substance which would be utilized in the clients’ buttocks injections and concealing the fact that the injected substance was, in fact, health-threatening silicone (Count 2). In addition, the defendants are charged with delivery for pay of a misbranded and adulterated medical device with intent to defraud and mislead (Counts 3-9). Jimenez is also charged with smuggling offenses (Counts 10-14) and false statement offenses (Counts 15-20).”
Compliance for Dummies
For those readers growing a little long in the tooth like Dr. D, you probably remember television shows such as Miami Vice and the drug smuggling movies such a “Blow.” According to the media, the only thing of substantial value being smuggled out of Colombia in the turbulent 1980’s was cocaine. Who would have thought that smuggling silicone for butt injections, many years later, would place money into the pockets of the smugglers? Seriously, smuggling silicone and making money doing it—who knew? Now smuggling silicone for the purpose of increasing the size of one’s backside, well that is going to tick off a bunch of government folks such as: (a) FDA’s Office of Criminal Investigations (FDA-OCI); (b) U.S. Immigration and Customs Enforcement; (c) Homeland Security Investigations (ICE-HSI); (d) Miami-Dade Police Department (MDPD); (e) the United States Attorney’s Office; and (f) the Federal Courts, which must be growing weary with all of the butt injection litigation activities.
From the FDA’s perspective, entering misbranded and adulterated medical devices (with intent to defraud and mislead) into commerce, is always going to end badly. Unfortunately, the folks on the receiving end of the buttocks enhancement just did not ask the right questions. You would think that prudent individuals would not find the spa to be an appropriate place for a medical procedure. Would you like a butt injection to go along with the massage and facial, it’s a mere few thousand dollars more? Seriously folks, the doctor does feel bad for the people on the receiving end of this adulterated product, as the outcome has the potential to cause some serious patient harm, including death. However, there does appear to be some level of common sense missing from the discussion. Has society become so vain in regards to looks that its members are willing to risk their lives to enhance their looks? Regardless of one’s opinion of the agency, the FDA is there to step up and protect the health of the American public, because it appears some folks are just not capable of taking care of themselves. With that said, Dr. D is going to go finish that jelly donut and chase it down with an Irish coffee, yummy!
For this week’s guidance the doctor is going to leave the readers with just one takeaway. For those of you who work hard each and every day to ensure your establishments place safe and effective innovative medical devices into commerce, thank you! The FDA expects your establishments to adhere with all applicable quality, regulatory, and statutory requirements. For those of you who are thinking about an elective procedure to enhance your already good looks and fine bodies, make sure you ask the right questions. If it sounds too good to be true, it probably is, and the end result may be hazardous to your health. 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.
- Code of Federal Regulation. (April 2016). Title 21 Part 820: Quality system regulation. Washington, D.C.: U.S. Government Printing Office.
- Code of Federal Regulation. (April 2016). Title 21 Part 803: Medical device reporting. Washington, D.C.: U.S. Government Printing Office.
- Devine, C. (2011). Devine guidance for complying with the FDA’s quality system regulation – 21 CFR, Part 820. Charleston, SC: Amazon.
- Devine, C. (2013). Devine guidance for managing key attributes of a FDA-compliant quality management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon.
- FDA. (February 2017). Inspections, Compliance, Enforcement, and Criminal Investigations. “February 14, 2017: Two Miami-Dade women
charged in connection with their operation of a spa performing illicit silicone injections.” Accessed February 20, 2017. Retrieved from https://www.fda.gov/ICECI/CriminalInvestigations/ucm541849.htm