It appears the saga associated with big butts continues. This time a woman was convicted and sentenced to 24 months in the slammer for injecting “lamb fat” into the buttocks of at least 10 victims. My dear readers, you cannot make this stuff up. The FDA identified the injection device as a medical device illegally smuggled into the United States as a medical device. It appears that the need for enhanced buttocks (big butt) continues to be a growing trend in the United States. That being said, the doctor attempted to reach out to the Office of Combination Products for a new device idea, an automated approach for quickly ingesting jelly donuts. Dr. D was informed that a knife and a fork, with a jelly donut attached, do not qualify as a medical device; however, an enteral feeding pump with a liquefied jelly donut is a medical device. Dr. D believes that regardless of the approach, consuming mass quantities of jelly donuts will be a sure-fire way to growing one’s backside, with only one serious side effect, the rest of one’s body will also grow. Seriously folks, if someone offers to inject something into your body and that procedure is not being performed by a healthcare professional in a clinical environment, then please ask questions or be prepared to suffer the consequences, or as Forest Gump would say, “stupid is as stupid does.” As for the perpetrator of these crimes (a.k.a. the perp), fustigation (look-it-up) is a just reward. Enjoy!

DOJ Press Release Excerpts – March 6, 2018

Monterey Park Woman Sentenced to Two Years in Prison for Injecting Foreign Substance into Woman for Buttocks Enhancement

“Diaz never told I.T. or her other customers that the product she was injecting into their buttocks had been illegally smuggled into the United States from Mexico, that the product was a medical device that was not approved for use in the United States for the purpose of enhancing buttocks or body contouring, and that she was not licensed in the United States to perform any such medical procedure.”

“Despite the risk of death or serious bodily injury to her customers, and notwithstanding complaints from customers that they had suffered injuries from the procedure, Diaz recklessly continued to inject her customers with the smuggled and illegal substance.”

Food for Thought

For this week’s guidance, the food for thought is to eat jelly donuts (just kidding). It is hard to fathom why some sick individuals would be willing to endanger an individual’s life in pursuit of the almighty dollar. The perpetrator of these heinous acts (Ana Bertha Diaz Hernandez) raked in $40,000 in a pure act of greed. Unfortunately, her actions are going to cost her big time, $125,000 ($95,000 fine and $30,000 in victim restitution) and an all-inclusive 24-month stay at a federal penitentiary not of her choosing.

On a serious note, if any of Dr. D’s dear readers is anticipating the need for any medical procedure, please do your homework in advance. It is imperative that you ask your healthcare provider questions pertaining to the procedure, the type of device(s) to be used, potential adverse events, and expected procedural outcomes. If you still have concerns, verify the credentials of the healthcare provider. Common sense is to not venture into a non-clinical setting to receive treatment (e.g., a hotel room). These types of medical adventures almost always end badly.

As industry professionals we clearly understand, medical device entered into commerce in the United States have three classes (I, II, or III) premised on risk. Class I devices generally require no review and can be entered into commerce once an establishment registered with the FDA and lists the device on the FURLS database. Most Class II devices require a submission in accordance with 21 CFR, Part 807 requirements and the obtainment of FDA clearance before entering a device into commerce. Class III devices require a pre-market approval (PMA) application to be made with the agency and approval to be obtained prior to commercialization.

Entering smuggle devices from south of the border, is always going to end badly. In fact, smuggling anything in the United States from south of the border is going to end badly.

If your desire is to enhance your buttocks (code for big butt in the doctor’s humble opinion) then stop exercising and start eating. Eat plenty of jelly donuts. In fact, eat all kinds of donuts. If you are not big on sugar, then consuming mass quantities of fast food burgers and fries should help you obtain that big butt look. If your liver is healthy, binge drinking is also a viable alternative to achieving an enhanced butt.

Closing Thoughts

There are people in this world willing to do some very bad things in pursuit of the almighty dollar. Their recklessness and lack of respect for their fellow humans is appalling and deserving of punishment appropriate to the crime. However, common sense goes a long way when it comes to preventing this type of behavior. It is incumbent upon us all to exercise common sense when it comes to medical procedures. Please ask questions or as us quality folks like to say, “Trust but verify.” 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.

References

1. Code of Federal Regulation. (2017, April). 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. (March 2018). “Monterey Park Woman Sentenced to Two Years in Prison for Injecting Foreign Substance into Woman for Buttocks Enhancement”. U.S. Department of Justice Press Release. Accessed June 11, 2018. Retrieved from https://www.fda.gov/ICECI/CriminalInvestigations/ucm599848.htm