Inspections, Compliance, Enforcement, and Criminal Investigations
March 28, 2012: Kimberly Smedley Admits Illegal Silicone Buttocks Injections in Hotel Room
Injected Silicone Intended to be Used as a Paint Additive or as Furniture/Automotive Polish;
Used Super Glue to Attempt to Prevent Silicone from Leaking
Baltimore, Maryland - Kimberly D. Smedley, age 45, of Atlanta, Georgia, pleaded guilty today to conspiring to introduce and deliver into interstate commerce an adulterated and misbranded device.
The guilty plea was announced by United States Attorney for the District of Maryland Rod J. Rosenstein and Special Agent in Charge Antoinette V. Henry of the U.S. Food & Drug Administration, Office of Criminal Investigations.
“Kimberly Smedley endangered her customers’ lives by injecting them with commercial silicone, causing at least one victim to suffer lung damage from a substance not approved by the Food and Drug Administration,” said U.S. Attorney Rod J. Rosenstein. “No one should undergo medical procedures in a hotel room.”
According to her plea agreement, from around 2003 to October 2011, Smedley administered silicone injections into the buttocks of customers for enlargement purposes. Smedley administered these injections in hotel rooms in Baltimore, Washington D.C., Detroit, New York City, Philadelphia and elsewhere, using silicone stored in an unlabeled water jug, medical grade syringes and super glue with cotton balls to cover the point of injection in an effort to prevent the silicone from leaking out. She was paid between $500 and $1,600 in cash for each session where she typically injected silicone in nine places on each side of the buttocks. Smedley received over $200,000 in cash for administering illegal silicone injections.
Smedley is not a licensed medical practitioner and the silicone is not approved by FDA for this purpose. Smedley represented to customers that she used medical grade silicone. However, the silicone Smedley used, 100 centistoke dimethyl siloxane fluid, is intended to be used for metal or plastic lubrication, as an additive for paint and coatings, and as furniture or automotive polishes. From one manufacturer alone, Smedley ordered over 4,920 pounds of the silicone since 2003 at a cost of over $20,000.
From 2009 to 2011, Smedley paid an individual to provide security in the hotel rooms where the injections were taking place.
On four occasions from October 2010 to March 30, 2011, an exotic dancer residing in Maryland paid Smedley to administer the injections. At the last treatment, the customer requested injections in her hips and Smedley complied. Two days later, suffering from shortness of breath, the customer went to Johns Hopkins Hospital where fluid was detected in her lungs and she was treated for pneumonia. A day and a half later, the customer felt worse and went to Good Samaritan Hospital in Baltimore. A CAT scan revealed silicone in the customer’s lungs, and she was diagnosed as having poisoning and toxic effects of silicone, with a major risk of death. She remained at the hospital for four days and still has silicone in her lungs.
Smedley faces a maximum penalty of five years in prison and a $250,000 fine. U.S. District Judge Catherine C. Blake has scheduled sentencing for July 12, 2012 at 9:15 a.m.
United States Attorney Rod J. Rosenstein commended the FDA - OCI for its work in the investigation and thanked Assistant United States Attorney Judson T. Mihok, who is prosecuting the case.