It appears that Dr. D just might be working in the wrong industry. One of the keys to financial success is the ability to quickly identify trends and then strike while the iron is still hot. Considering that this is the third time during the previous 12 months that the doctor has come across a press release depicting DOJ working with the FDA to stop individuals from assisting in the growing of big butts (in South Florida), there is an obvious trend and market need. The question is, “How does one enter into the big butt market place legally?” Obviously, injecting industrial-grade silicone, procured from the local hardware store, appears to be problematic, and so finding a legal solution is the key to market entry. As the doctor has mentioned in previous articles, deep-fried dough filled with jelly and covered with tons of sugar is a sure-fire solution for those individuals wanting to grow their butts. Unfortunately, all other parts of the body tend to grow in proportion with the butt. And, having individuals (non-licensed practitioners) armed with an injection device and silicone from a questionable source can result in tragic patient outcomes. According to the DOJ press release, “the potential of injection into a blood vessel resulting in embolism, migration of injected silicone to other bodily regions and resultant interference with organs and bodily systems, serious sepsis infection and infection-related disorders, silicone-filled scar tissue formations granulomas [look-it-up], necrosis, skin discoloration, immune system hyperactivity and related adverse systemic conditions, disfigurement, discomfort, and pain,”— oh my. The doctor thinks that death may also be a potential adverse event considering the lengthy list extracted from the press release. Unfortunately, Dr. D believes that it may not be possible to teach positive deportment (look-it-up) in some of these offending individuals in an effort to curtail criminal behavior.

U. S. Department of Justice Press Release Excerpt

“Kerlys Mercedes Chaparro, 39, of Miami-Dade County, Florida, is charged by indictment with delivery for pay of an adulterated and misbranded device received in interstate commerce with intent to defraud and mislead, in violation of Title 21, United States Code, Sections 331(c) and 333(a)(2).”
“The indictment alleges that on or about July 27, 2016, Chaparro received a device (a silicone substance) that she intended to inject into the human body of another individual in exchange for payment. Chaparro was not a licensed medical practitioner. The silicone substance was allegedly misbranded, in that it had false and misleading labeling. Chaparro intended to inject this silicone substance, that had not been approved by the FDA, into the other individual’s body for contouring purposes.”

Common Sense for the General Population

My dear readers, it is up to us to educate our family and friends about the dangers associated with the practicing of backroom medicine, with unlicensed practitioners delivering therapy through the use of adulterated and misbranded medical devices. Dr. D has never had any sort of fetish for big backsides and attempts to exercise daily to keep the girth of the old doctor’s backside down. However, it appears that there is some sort of mystical allure to having a large derriere (look-it-up). Considering the well-publicized risks associated with illegal injections versus knowing that the only well-known death associated with the consumption of a donut was the death of the king of rock and roll, sitting on his porcelain throne (allegedly), the doctor thinks donuts are a safer option. Dr. D’s potential ownership of a donut shop, affectionately named Dr. D’s Big Butt Factory, could be in the cards when the old doc finally decides to retire from the medtech industry.

On a serious note, people really do need to exercise some level of common sense when it comes to medicine. Elective medical procedures such as “buttocks injections” should occur in a medical suite, performed by qualified and licensed healthcare professionals, using medical devices cleared by FDA. If an individual offers to perform the procedure in the comfort of a local motel and the silicone is removed from a bag that reflects the name of a local hardware store, Houston, we have a problem. Run for your life, because your life may depend upon it. If any of the readers overhear friends and family talking about such shenanigans resulting in medical mishaps (a.k.a., adverse events), as medtech industry professionals it is incumbent upon us to notify the proper authorities.

If any of the readers want to enlarge their backsides, start slowly with a regimen of one jelly donut a day. Slowly work your way up to a baker’s dozen while cutting back on the exercise. The doctor promises that big butt and matching waistline will be in your future. Unfortunately, a visit to the cardiologist may also be in your future.

Takeaways

For this week’s guidance, there are no takeaways, just some humor and a word of caution. There are bad people out there willing to risk people’s lives in pursuit of the almighty dollar. It is unconscionable that unscrupulous characters are willing to take advantage of the vanity found in some people. Only through education and the exhibiting of some good-old-fashion common sense can we bring the big butt saga to an end. 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. (April 2017). 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. (July 2018). Inspections, Compliance, Enforcement, and Criminal Investigations. “July 26, 2018: Miami-Dade Resident Charged in Connection with Performance of Illicit Silicone Injections”. Accessed September 8, 2018. Retrieved from https://www.fda.gov/ICECI/CriminalInvestigations/ucm615150.htm