Cosmetic procedures are increasingly common these days, but so are illegally run clinics that promise to improve a person’s appearance while endangering their clients’ lives for the sake of profit. Two recent cases highlight the continuing efforts of the United States Department of Justice (DOJ) and the United Stated Food and Drug Administration (FDA) to combat this public threat.
Kendra Westmoreland of Maryland pleaded guilty to receiving and delivering an adulterated or misbranded device. She treated customers with polydimethylsiloxane, telling them it was medical grade silicone. Polydimethylsiloxane is used in the manufacture of shampoos (to make hair shiny and slippery), food (as an antifoaming agent), caulking, lubricants, kinetic sand, and heat-resistant tiles.
According to the plea agreement, from October 2000 to October 2015, Westmoreland injected polydimethylsiloxane directly into the bodies of her customers for money. She also told her clients that she was medically licensed to perform the procedure, even though she was never a licensed medical practitioner and silicone is not approved by the FDA for this purpose.
When police searched her home in October 2015, they found a room set up to resemble an operating room with medical equipment and collages of photographs of individuals exposing their buttocks, representing a sampling of those who Westmoreland had injected with silicone. A search of her cell phone found the contact information for 126 of her clients. According to a financial audit, Westmoreland made deposits totalling $276,795 between December 2011 and October 2015. The same audit indicated that she filed no tax returns and made no tax payments during that period.
Sentencing of Westmoreland is expected soon. Assistant U.S. Attorney Judson T. Mihok prosecuted the case.
Further down the eastern seaboard, Maribel Jimenez and Magaly Del Rosario of Miami-Dade, FL face a twenty-count federal indictment. The indictment alleges that Jimenez and Del Rosario conspired to receive and deliver an adulterated and misbranded medical device in connection with their unlawful receipt and use of silicone between 2008 and August 2015. They allegedly smuggled the black market silicone into the U.S. from Colombia, and injected it into hundreds of clients who were seeking augmentation of their buttocks. According to the indictment, they also administered injections of misbranded prescription drugs, including lidocaine and Botox. Other charges include conspiring to commit wire and mail fraud, delivery for pay of a misbranded and adulterated medical device with intent to defraud and mislead, smuggling offenses and making false statements.
Jimenez and co-conspirators smuggled the silicone into the U.S. by means of approximately 170 separate DHL air carrier shipments. To avoid the scrutiny of Customs and Border Protection, each bottle contained false labelling stating in Spanish that the contents consisted of “Depilatory Wax.” Multiple Bella Beauty Spa clients complained to Jimenez that they were experiencing adverse health symptoms after the receiving injections. Jimenez and Del Rosario failed to tell their clients that silicone had been injected into their bodies and they concealed the potential health consequences of injecting silicone into their clients’ bodies.
Justin D. Green, Special Agent in Charge, FDA-OCI Miami said, “Serious harm, including death, can occur when individuals have liquid silicone or other substances injected into their buttocks to increase their size. The FDA has not approved liquid silicone or other injectable substances to increase the size of the buttocks. Our office will continue to pursue and bring to justice those who offer this hazardous procedure to the public.” Wifredo A. Ferrer, United States Attorney for the Southern District of Florida stated, “Criminal conduct that poses a significant health risk to the general public is of grave concern to the U.S. Attorney’s Office. Federal prosecutors and our law enforcement allies are committed to disrupting illicit operations that hold themselves out to be legitimate medical facilities while endangering lives for profit.”
The FDA has never approved liquid silicone or silicone gel for injection anywhere in the human body. Complications from injecting silicone include pulmonary embolism, kidney failure, infection, nerve damage, chest pain and breathing problems due to the silicone moving to other parts of a person’s body and death.