My dear readers, what you are about to read, one cannot make this stuff up. Now granted, maybe a good fiction writer can make this stuff up, but (please keep the word “but” in mind as you read this week’s Guidance) Dr. D cannot spin this type of wild tale. Now the doctor is quite sure many of the readers remember the PIP debacle (The French breast implant company using industrial grade silicone and falsifying records) and the trials and tribulations of their former founder Jean-Claude Mas. Mas eventually received a four-year prison sentence and was fined €75,000. Now the old doctor realizes that PIP is old news, and Mas has probably paid his debt to society. However, whenever the FDA investigates people using silicone inappropriately it is inevitable such bad deeds are going to grab some press time through the coveted U.S. Department of Justice Press Release. These proceeding typically end badly for the offending establishment or offending person(s). All one has to do is turn on the evening news or pick up a local rag and read about all of the bad things happening in the world, and it is no wonder individuals continue to stick their heads in the proverbial sand while transforming themselves into misanthropes (look-it-up). However, for establishments and Chief Jailable Officers (CJO) that run afoul of FDA, DOJ, CIA, NSA, or the local PTA (enough acronyms for you), there is just no place to hide. Enjoy!
Doctor D’s Disclaimer – The individual under indictment for these alleged charges is considered innocent until proven guilty in accordance federal statutes. It is the law!
According to recently released DOJ Press Release (August 2, 2016) Juan David Acousta (a Colombian national) was 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. Additionally, Acousta was charged with two counts of receipt in interstate commerce of a misbranded medical device and delivery for pay with intent to defraud or mislead (Violation of Title 21, United States Code, Sections 331(c) and 333(a)(2)). If convicted, Acousta faces a maximum statutory sentence of three years in prison as to each count and severe fiscal penalties, as deemed appropriate by the courts.
Furthermore, the injections of silicone allegedly administered by Acousta were made into the butt cheeks of unsuspecting patients (two) who paid thousands of dollars for this treatment. Seriously? Butt injections? If there are individuals in need of bigger butts, Dr. D will gladly offer a few pounds from his butt cheeks. There is one catch though: The procedure for removing the unwanted fat from Dr. D’s behind must be painless. Seriously, having an alleged individual practicing medicine without a license and injecting stuff into patients has the potential to end very badly for the patients. Performing the injections without benefit of the appropriate medical credentials and using devices and associated materials not approved by FDA is always going to end badly for the offending establishment or individual.
Takeaways
For this week’s guidance, there is not a whole lot that Dr. D can add to the FDA’s and DOJ’s case. If a supposed healthcare provider asks a potential client to come to his or her home for the purpose of receiving a silicone injection in the buttocks, well that should always raise a big red flag. If the silicone is being pulled from a box from the local hardware store, just use those legs attached below those skinny butt cheeks and run, baby run! 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
- Code of Federal Regulation. (April 2015). Title 21 Part 820: Quality system regulation. 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. (August 2016). Inspections, Compliance, Enforcement, and Criminal Investigations. Colombian national charged for unlawfully injecting silicone into victims’ bodies. Accessed August 01, 2016. Retrieved from http://www.fda.gov/ICECI/CriminalInvestigations/ucm514579.htm
Related Articles
-
Effective February 7, the agency will conduct inspections across all commodities, as well as mission-critical foreign and domestic inspections.
-
The draft guidance proposes updates to clarify how the Breakthrough Devices Program may be applicable to certain medical devices that promote health equity, as well as considerations in designating eligible devices that may benefit populations impacted by disparities in health…
-
As of June 1, 2022, the Center for Devices and Radiological Health plans to accept all non-COVID in vitro diagnostic (IVD) pre-submissions.
-
The updated guidance document clarifies what constitutes a statement of the basis for the deficiency and includes examples of well-constructed deficiencies and industry responses to facilitate a more efficient review process.
