Dr. Christopher Joseph Devine, President, Devine Guidance International
Devine Guidance

FDA and DOJ Working Together: No If, Ands, or Butts: Part Deux

By Dr. Christopher Joseph Devine
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Dr. Christopher Joseph Devine, President, Devine Guidance International

What compels CJOs to misuse silicone products and put their victim’s health in such peril?

Back in early August, Dr. D wrote about Juan David Acousta (a Colombian national) being charged criminally for unlawfully injecting silicone into victims’ bodies for aesthetic enhancements, without the benefit of a medical license or obtaining medical device approval from the FDA. The doctor must admit he was quite surprised when a few weeks later another brilliant individual, going by the name of “T” was sentenced to 14 years in a federal big house for similar transgressions. Only this time someone was killed. Additionally, the second offender, now a convict, used industrial-grade silicone. Are you kidding me? People, you just cannot make this stuff up. Obviously, the individual mentioned in this week’s guidance lacked the sagacious (look-it-up) farsightedness to make prudent and moral decisions, and as a result, became the ultimate Chief Jailable Officer, a.k.a., himself. Enjoy!

Department of Justice Press Release – August 19, 2016 (Excerpts)

“Greenbelt, Maryland – U.S. District Judge George J. Hazel sentenced Vinnie Lysander Taylor, a/k/a “T,” age 44, of Wilmington, North Carolina, Pennsylvania and Georgia, today to 14 years in federal prison, followed by three years of supervised release, for receiving and selling industrial grade silicone, but representing to customers that it was medical grade silicone.  A client died as a result of receiving such injections.”

“Taylor admitted that from at least 2008 through December 16, 2014, he administered silicone injections into the buttocks of customers who wanted larger or fuller buttocks. Taylor, who was not a licensed medical practitioner, falsely represented to customers and victims to whom he administered liquid silicone injections that the procedure was safe and that he used medical grade silicone, when in fact the silicone was not medical grade silicone. Taylor administered the injections in hotel rooms in Prince George’s County, Maryland, St. Louis, Missouri, Arlington, Virginia, and elsewhere. Taylor charged between $800 and $1000 for the initial injections and between $350 and $800 for subsequent injections. When used in this fashion, liquid silicone is a medical device subject to regulation by the FDA.”

Please Note: you can follow the link at the end of this week’s guidance to visit the full DOJ press release.

What Is Wrong with This Picture?

Dr. D always thought that eating a bunch of jelly doughnuts, while sitting on one’s buttocks, without the benefit of exercise, would eventually result in the proverbial big butt. Do people really want this look? In fact, Dr. D is constantly fighting an uphill battle to prevent this look. My dear readers, if someone approaches you and offers to inject your backside full of silicone, in the comfort of a local hotel room, run away quickly. You will also be performing a public service for your fellow citizens by making a call to the local authorities.

Now granted, there are still some doctors out there who will make house calls when people are in dire need for some medical attention. However, butt injections probably do not fit into the normal profile for a house call. For example, Dr. D thinks that calls such as: “Hey doc, my wife is not feeling well, can you come over and have a look at her, and by the way, she would like some silicone butt injections while you are here.” Seriously? If your doctor’s name is “T” (a.k.a., Vinnie Lysander Taylor, now serving 14 years in a federal penitentiary), and the silicone is in a bag with the local hardware store’s logo, bad things are going to happen. No crystal ball is needed to predict the patient outcomes.

I guess what really spooks Dr. D, is the continued misuse of silicone. First it was Jean-Claude Mas (the PIP debacle in France and the EU), then Juan David Acousta’s indictment earlier this summer in South Florida, and now T’s 14-year sentence in Maryland. What compels these individuals to misuse silicone products, while placing the health of their victims in great peril? Dr. D hopes there will not be a “Part Tres” to this series, however, the doctor is not a gambling man. The doctor does believe that silicone has some viable uses around the house such as plumbing fixtures and windows. Additionally, there is a food-grade silicone available. Unfortunately, when you read the applications and directions for use for these products, butt injections cannot be found on the labels. How does Dr. D know these things? The doctor is reading the directions for use and applications for use on a tube of silicone, which was sitting on a shelf in the garage, as he writes this week’s article. The word “buttocks” is not mentioned anywhere. What a surprise? Maybe this is an opportunity for a new warning label affixed to industrial-grade silicone. “Warning, this product is not to be used for Buttock Injections!” Just kidding.

Doctor D’s Disclaimer – Juan David Acousta is only under indictment for his alleged charges and is considered innocent until proven guilty in accordance federal statutes. It is the law!

Takeaways

For this week’s guidance, there are no takeaways. However, I want each of the readers to think about the potential for medical fraud, abuse and untold horrors that face an unsuspecting public when bad apples do bad things with medical devices for the sake of making money. If one is inclined to receive silicone injections in the butt, there are trained healthcare professionals and accredited physicians capable of performing this procedure. However, a few dozen jelly doughnuts, washed down with your favorite pop, just might do the trick. In fact, the doctor will end this week’s guidance with a little quote associated with the jelly doughnut theory: “Less pain and plenty to gain.” In closing, thank you again for joining Dr. D, and I hope you found value in the guidance provided. Until the next installment of DG, cheers from Dr. D., and best wishes for continued professional success.

References

  1. Code of Federal Regulation. (April 2015). Title 21 Part 820: Quality system regulation. Washington, D.C.: U.S. Government Printing Office.
  2. Devine, C. (2011). Devine guidance for complying with the FDA’s quality system   regulation – 21 CFR, Part 820. Charleston, SC: Amazon.
  3. Devine, C. (2013). Devine guidance for managing key attributes of a FDA-compliant quality management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon.
  4. FDA. (August 2016). Inspections, Compliance, Enforcement, and Criminal Investigations. North Carolina man sentenced to 14-years in federal prison for providing silicone buttocks injections resulting in the death of a client. Accessed September 6, 2016. Retrieved from http://www.fda.gov/ICECI/CriminalInvestigations/ucm517411.htm

About The Author

Dr. Christopher Joseph Devine, President, Devine Guidance International

Comments

  1. Mike Regan

    Some years ago I was QA manager for a company which manufactured industrial silicone for use in sealing doors and windows in the building trade. One of the customer service operators recived a letter from a customer regarding the hazard warnings on the side of the pack he had previously used a competitors product to keep his dentures in place. The product was low modulus Acetoxy silicone which gives off acetic acid (vinigar to you and me). You can only imagin the state of his gums.

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