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Acute Renal Failure Associated with Cosmetic Soft-Tissue Filler Injections

North Carolina, 2007

1

Soft-tissue fillers are substances injected to augment or

hance the appearance of lips, breasts, buttocks, or other ft tissues. Previous reports have linked the administra

in of soft-tissue fillers, usually liquid silicone, by unliused practitioners to severe adverse events, including death 1-9). On December 27, 2007, the North Carolina Diviin of Public Health (NCDPH) was notified of three cases

renal failure occurring among women who had received smetic soft-tissue filler injections at a facility in North urolina (facility A). This report summarizes the clinical 9.dings for these cases and describes the subsequent pub

health investigation. All injections were administered

a practitioner with no medical training or supervision ractitioner A). Investigators were not able to identify the bstances injected. Although records indicated that the jections contained liquid silicone, this substance has not

en associated previously with renal failure. These findgs underscore the risks posed by cosmetic injections ad

inistered by unlicensed practitioners. Public health ficials should be alert for adverse events associated with

ese injections and take all necessary actions to prevent ditional injuries.

enced headache and vomiting within 30 minutes of these injections and noted that her urine looked like purple blood. She went to an emergency department (ED) in Maryland on December 24 with fatigue, vomiting, and headache and was found to be in acute renal failure, with a serum creatinine level of 4.2 mg/dL (normal: 0.8-1.4 mg/dL). Laboratory investigations, including urine testing for heavy metals, did not reveal a specific etiology. Her serum creatine phosphokinase (CPK) level was 411 U/L on the day of admission (normal: 25–200 U/L). She remained hospitalized for 10 days. Hemodialysis was not required, and her serum creatinine level subsequently returned to normal.

Case 2. On December 8, 2007, a previously healthy Illinois woman aged 26 years received cosmetic soft-tissue filler injections in her buttocks at facility A. Records indicated that she received 500 mL of “25% silicone dermal filler and 75% saline solution" in each buttock (1,000 mL total). She received additional injections at facility A on December 22. Records from December 22 indicate that 400 mL of a “50% concentration of silicone oil dermal filler and saline solution” were injected into each buttock

ase Reports Case 1. On December 8, 2007, a District of Columbia oman aged 42 years, who was previously healthy except ra history of anemia, received cosmetic soft-tissue filler jections in her buttocks at facility A. Records specifying e substance injected were unavailable. On December 22, e woman received additional injections at facility A. cording to facility records, 300 mL of "dermal silicone/ ine solution” were injected into each buttock (600 mL tal) during the December 22 visit. The woman experi

INSIDE 457 Syncope After Vaccination — United States, January

2005-July 2007 460 Human Rabies — Minnesota, 2007 462 Report from the Advisory Committee on Immunization

Practices (ACIP): Decision Not to Recommend Routine
Vaccination of All Children Aged 2-10 Years with

Quadrivalent Meningococcal Conjugate Vaccine (MCV4) 465 Notices to Readers 467 QuickStats

DEPARTMENT OF HEALTH AND HUMAN SERVICES

CENTERS FOR DISEASE CONTROL AND PREVENTION

The MMWR series of publications is published by the Coordinating
Center for Health Information and Service, Centers for Disease
Control and Prevention (CDC), U.S. Department of Health and
Human Services, Atlanta, GA 30333.
Suggested Citation: Centers for Disease Control and Prevention.
[Article title]. MMWR 2008;57:[inclusive page numbers).
Centers for Disease Control and Prevention
Julie L. Gerberding, MD, MPH

Director
Tanja Popovic, MD, PhD

Chief Science Officer
James W. Stephens, PhD
Associate Director for Science

Steven L. Solomon, MD
Director, Coordinating Center for Health Information and Service

Jay M. Bernhardt, PhD, MPH
Director, National Center for Health Marketing

Katherine L. Daniel, PhD
Deputy Director, National Center for Health Marketing
Editorial and Production Staff

Frederic E. Shaw, MD, JD
Editor, MMWR Series

Teresa F. Rutledge
(Acting) Managing Editor, MMWR Series

Douglas W. Weatherwax
Lead Technical Writer-Editor
Donald G. Meadows, MA

Jude C. Rutledge

Writers-Editors

Peter M. Jenkins
(Acting) Lead Visual Information Specialist

Lynda G. Cupell

Malbea A. LaPete
Visual Information Specialists
Quang M. Doan, MBA

Erica R. Shaver
Information Technology Specialists

(800 mL total). Within 1 hour of these injections, st: experienced headache and nausea and noted that her un had a burgundy color. She went to an Illinois ED December 23 with nausea, headache, and fatigue and H. found to be in acute renal failure, with a serum creatinin level of 4.0 mg/dL. Serum CPK was 517 U/L on the day o admission. The patient's renal function worsened, ani hemodialysis was initiated. A renal biopsy on Decembe 27 revealed severe acute tubular necrosis with cast form. tion. The casts were not myoglobin or hemoglobin pathologists were unable to determine their composition despite the use of specialized stains. No heavy metals wer: identified in urine specimens, and no other specific etc: ogy was identified. The woman remained in the hospiz for 13 days. Hemodialysis was discontinued after 5 week and the woman subsequently regained normal kidne function.

Case 3. A previously healthy Maryland woman aged 2 years received soft-tissue filler injections in her buttocks a facility A on December 8, 2007, and again on December 22. No records were available from either date. The womi developed abdominal pain, lightheadedness, and nausei within 1 hour after the second procedure. She went to a. ED on December 26 with fatigue and vomiting and wa found to have a serum creatinine level of 11 mg/di Hemodialysis was initiated. A renal biopsy on January 11 2008, demonstrated acute interstitial nephritis with substantial numbers of eosinophils, consistent with a toxic or allergic etiology. Eosinophilia was not found on peripherblood smears. No heavy metals were identified in urin specimens. She remained in the hospital for 14 dars hemodialysis was discontinued within 1 week after di charge, and her serum creatinine level subsequently returne to normal.

Editorial Board William L. Roper, MD, MPH, Chapel Hill, NC, Chairman

Virginia A. Caine, MD, Indianapolis, IN

David W. Fleming, MD, Seattle, WA
William E. Halperin, MD, DrPH, MPH, Newark, NJ
Margaret A. Hamburg, MD, Washington, DC
King K. Holmes, MD, PhD, Seattle, WA
Deborah Holtzman, PhD, Atlanta, GA

John K. Iglehart, Bethesda, MD
Dennis G. Maki, MD, Madison, WI
Sue Mallonee, MPH, Oklahoma City, OK

Stanley A. Plotkin, MD, Doylestown, PA
Patricia Quinlisk, MD, MPH, Des Moines, IA
Patrick L. Remington, MD, MPH, Madison, WI

Barbara K. Rimer, DrPH, Chapel Hill, NC
John V. Rullan, MD, MPH, San Juan, PR

Anne Schuchat, MD, Atlanta, GA
Dixie E. Snider, MD, MPH, Atlanta, GA

John W. Ward, MD, Atlanta, GA

Public Health Investigation

On December 27, 2007, NCDPH was notified of thes three cases by a District of Columbia nephrologist wha had treated one of the patients. This patient was aware of : second ill patient, and the physician learned of the thiru after contacting practitioner A. Case investigations wers conducted, including interviews with the three patients and their physicians and medical record reviews. Facility A was first inspected on December 28 to identify products and materials used in the procedures, evaluate infectioncontrol practices, review records pertaining to facility patients, and interview practitioner A. Subsequent inspettions and interviews were conducted on January 3 and January 10, 2008. Other patients identified from facilin

interviews with practitioner A as having ions at facility A also were interviewed to iden

| cases.

the index patients learned of facility A directly through Internet chat rooms and had ed on price and a perception that the procebed presented a low risk for adverse effects performed in a clinic. All three patients were tioner A that she was under the supervision , although none had seen a physician during wo of the patients had traveled to facility A hird had no association with the others. None ts reported any illicit drug use or common ood or drinks. ives of the Guilford County Health DepartCDPH interviewed practitioner A and conions of facility A with assistance from CDC,

Drug Administration, the North Carolina ug Protection Division, the North Carolina gram for Infection Control and EpidemiolNorth Carolina Medical Board. Multiple andard infection-control practice were noted Records pertaining to facility A patients were ite. However, these records contained scant egarding procedure techniques and materials some cases, conflicted with information obh patient interviews. All patients had signed | “Consent to Treatment.” However, these - mention soft-tissue filler procedures or the - associated with these procedures. Although the patients in cases 1 and 2 indicated that ived dermal silicone, investigators were not m which substances had been injected or how

procured. No residual products or materials ft-tissue filler injections were available at the oner A claimed that she had injected a spemedical-grade silicone oil mixed with saline. provided no invoices, ordering information, ence to support this claim.

A had trained as a radiology technician and ering the soft-tissue filler injections without rvision. Signage and promotional materials he Internet and in facility A referred to the mily medicine practice and used the name of icine physician licensed in North Carolina. s physician had no recent affiliation with no involvement with the soft-tissue filler prodition to soft-tissue fillers, practitioner A was

administering small volumes of other injectable products purported to produce weight loss.

Investigators were unable to determine how long practitioner A had been administering soft-tissue filler injections or how many patients had received them. Practitioner A initially reported that 50 persons had received these injections at facility A over a 1-year period. However, only five additional recipients were identified through subsequent reviews of facility records and interviews with practitioner A. Investigators were able to contact four of these patients. All were women and had received injections during November 17-December 18, 2007. Three resided outside North Carolina. According to facility records, three had large volumes (540–1,000 mL) of silicone oil and saline injected in the buttocks; the fourth received small-volume facial injections. Practitioner A stated that all four of these women had received silicone oil from the same shipment as the index patients, although she provided no evidence to support this claim. One of the four patients had experienced pink urine transiently after the procedure, which she attributed to menstrual bleeding. None of the other three women reported adverse effects. All four women were encouraged to see their physicians and have their renal function tested; results of these evaluations are not known. Six persons identified from facility records as having received other types of injections during the same period were contacted; three did not report any adverse events associated with these injections, and three reported various symptoms, including nausea, bruising, diarrhea, and weight gain.

On December 28, 2007, notification regarding this cluster was posted on CDC's Epidemic Information Exchange (Epi-X) and distributed to nephrologists and toxicologists throughout the United States. No additional cases have been reported in response to these notifications. On January 16, 2008, NCDPH issued a press release. After reports appeared in the local media, the Guilford County Health Department received calls from five persons reporting adverse events after injections at facility A. Four callers reported injection-site reactions, including knots, inflammation, abscesses, and ulcers. The fifth caller reported being hospitalized for a pulmonary embolism approximately 3 weeks after her last injection. Each of these persons reported receiving small-volume injections of various substances purported to produce weight loss; none reported receiving silicone oil or other soft-tissue fillers.

On December 28, 2007, the Guilford County Health Director issued an abatement order prohibiting any owner or employee at facility A from administering injections

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ticing medicine without a license to third-degree murd: (4). Few data are available regarding the incidence adverse events after administration of silicone oil softfillers by licensed medical providers (1). No adverse even were reported among 77 patients in a recent pilot trial highly purified silicone oil for treatment of human imm. nodeficiency virus-associated facial lipoatrophy (10).

Soft-tissue filler injections should be administered on by licensed providers with appropriate medical training Laws governing medical procedures vary by state. In Nors Carolina, all injections are considered medical procedur and must be performed or supervised by licensed phys. cians. The cases described in this report and the other 23 verse events reported among clients of facility A serve :remind consumers and public health officials of the sun stantial risks associated with cosmetic procedures performa by unlicensed practitioners.

containing silicone oil. On January 3, 2008, this order was expanded to prohibit administration of all injections. The findings of this investigation were presented to the local district attorney; practitioner A subsequently was arrested and charged with practicing medicine without a license. Reported by: M Branton, MD, AD Bivins, MD, District of Columbia. LTR Terrado, MD, Olympia Fields, Illinois. M Green, MPH, Guilford County Health Dept; R Langley, MD, D Campbell

, MD, North Carolina Div of Public Health. M Sutter, MD, J Schier, MD, J Lando, MD, National Center for Environmental Health; PR Patel

, MD, M Jhung, MD, National Center for Preparedness, Detection, and Control of Infectious Diseases; B Goode, MPH, Coordinating Office for Terrorism Preparedness and Emergency Response; ZS Moore, MD, EIS Officer, CDC. Editorial Note: This report describes three cases of acute renal failure that were identified among patients receiving injections of an unknown substance from an unlicensed and unsupervised practitioner. These cases illustrate the dangers of receiving cosmetic injections from unlicensed practitioners.

The substance injected was reported to be silicone oil, although this could not be verified. The etiology of renal failure also could not be determined. Renal failure has not previously been associated with silicone injections, increasing the likelihood that another substance might have been involved in these cases. The lack of residual product or documentation and inconsistent information from the practitioner complicated efforts to investigate this possibility. Previous reports have indicated that products misidentified as silicone oil might contain other substances, such as mineral oil, linseed oil, or flax oil (2). No liquid silicone products are currently approved or cleared by the Food and Drug Administration for cosmetic injection. However, such products are licensed for other indications, and off-label use within a legitimate practitioner-patient relationship is not generally prohibited by federal law.*

Various adverse events have been reported in association with cosmetic silicone injections, including granuloma formation, infection, pneumonitis, pulmonary embolism, ulceration, product migration, and death (1-7). Most reported adverse events have occurred after injections by unlicensed practitioners using formulations not intended for medical use (2-7). These formulations often are administered in large volumes and might be intentionally adulterated with tissue irritants to increase swelling or unintentionally adulterated with microorganisms or other contaminants (2,3). Practitioners implicated in similar episodes have been convicted of offenses ranging from prac

Acknowledgments The findings in this report are based, in part, on contributions tes". D Pittman, North Carolina Medical Board; D Weber, MD, UN North Carolina School of Medicine; K Carter, RS, Guilford Coun: Health Dept; D Ragan, RPh, J Reardon, North Carolina Dept Agriculture and Consumer Svcs; D Bergmire-Sweat, MPH, Nur Carolina Div of Public Health; and T Berry, RPh, Food and Dr. Admin.

References 1. Hexsel DM, Hexsel CL, Iyengar V. Liquid injectable silicone: histur

mechanism of action, indications, technique, and complications. Ser?

Cutan Med Surg 2003;22:107–14. 2. Hage JJ, Kanhai RC, Oen AL, van Diest PJ, Karim RB. The devastag

outcome of massive subcutaneous injection of highly viscous fluid

male-to-female transsexuals. Plast Reconstr Surg 2001;107:34 3. Fox LP, Geyer AS, Husain S, Della-Latta P, Grossman ME

Mycobacterium abscessus cellulitis and multifocal abscesses of the bitin a transsexual from illicit intramammary injections of silicone. ! A

Acad Dermatol 2004;50:450-4. 4. Price EA, Schueler H, Perper JA. Massive systemic silicone emboli

a case report and review of the literature. Am J Forensic Med Part

2006;27:97-102. 5. Chastre J, Brun P, Soler P, et al. Acute and latent pneumonitis at

subcutaneous injections of silicone in transsexual men. Am Rev Ress

Dis 1987;135:236–40. 6. Chen YM, Lu CC, Perng RP. Silicone fluid-induced pulmonar

embolism. Am Rev Respir Dis 1993;147:1299–302. 7. Duong T, Schonfeld AJ, Yungbluth M, Slotten R. Acute pneumopat

in a nonsurgical transsexual. Chest 1998;113:1127-9. 8. Toy BR, Frank PJ. Outbreak of Mycobacterium abscessus infection at

soft tissue augmentation. Dermatol Surg 2003;29:971–3. 9. Rollins CE, Reiber G, Guinee DG, Lie JT. Disseminated lipogranul

mas and sudden death from self-administered mineral oil injectiu!

Am J Forensic Med Pathol 1997;18:100–3. 10. Jones DH, Carruthers A, Orentreich D, et al. Highly purified 21.

cSt silicone oil for treatment of human immunodeficiency via associated facial lipoatrophy: an open pilot trial. Dermatol Surg 20 :30:1279-86.

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* Food and Drug Administration Modernization Act (FDAMA) of 1997. Public

law 105-115, section 214. Available at http://www.fda.gov/cder/guidance/105115.htm.

yncope After Vaccination United

States, January 2005-July 2007 Syncope (vasovagal reaction), or fainting, can be triggered

various stimuli, including medical procedures (1–3). ncope has been documented to occur after vaccination, cost commonly among adolescents, and can result in hos-calization for a medical evaluation or because of injury .,4). During 2005 and 2006, the Advisory Committee 5: Immunization Practices (ACIP) recommended use of ree newly licensed vaccines for adolescents*: the quadrivaat human papillomavirus recombinant vaccine (HPV) -ardasil®, Merck & Co., Inc., Whitehouse Station, New :sey) in a 3-dose series, the quadrivalent meningococcal njugate vaccine (MCV4) (Menactra®, Sanofi Pasteur, Inc., riftwater, Pennsylvania) in a single dose, and the tetanus xoid, reduced diphtheria toxoid, and acellular pertussis ccine (Tdap) (Adacel®, Sanofi Pasteur; Boostrix®, axoSmithKline Biologicals, Research Triangle Park, North urolina) in a single dose. To describe trends in occurrence

postvaccination syncope, CDC and the Food and Drug Iministration (FDA) analyzed data from the Vaccine

Iverse Event Reporting System (VAERS) for January 1, : 05-July 31, 2007, and compared the results with VAERS ports received during January 1, 2002-December 31, 04. The findings indicated that, since 2005, reports to WERS regarding postvaccination syncope have increased, imarily among females aged 11-18 years, and rarely, subquent serious injuries have occurred. To prevent syncopeated injuries, vaccine providers should follow the ACIP commendation to strongly consider observing patients [ 15 minutes after vaccination (4). VAERS, a passive surveillance system operated jointly by DA and CDC, receives reports of vaccine adverse events AEs) and is designed to generate, not test, vaccine-safety potheses (5). Detecting new or rare VAEs, monitoring inds in known adverse events, and identifying risk factors t particular types of VAEs are the primary objectives of AERS (5). Reports included in this analysis were those ceived by VAERS during January 1, 2005-July 31, 2007,

that had VAEs coded as “syncope” or “syncope vasovagal,” on the basis of coding terms from the Medical Dictionary for Regulatory Activities (MedDRA®). S Reports to VAERS typically involve multiple coding terms. Because vasovagal reactions have a relatively rapid onset and syncope is less likely to occur in young children, only reports of

persons who had syncope onset after vaccination on the same date and were aged 25 years at the time of vaccination were included in the analysis. Persons with either unknown age or unknown date of syncope onset were excluded.

The rate of reports for postvaccination syncope was calculated by dividing the total number of reports by the net number of doses of vaccine distributed in the United States each year (CDC, unpublished data, 1991–2006). Patient characteristics, including age, sex, and vaccines received, were compiled. To assess trends, these variables were compared with VAERS reports of syncope during January 1, 2002-December 31, 2004. Adverse events were defined as serious if one or more of the following patient outcomes were indicated in the report: death, life-threatening illness, hospitalization, prolonged hospitalization, or permanent disability. For each serious event, the narrative descriptions of VAEs and medical records were reviewed by CDC medical officers to validate the diagnosis of syncope, determine the interval between vaccination and onset in minutes, and identify any syncope-related injuries.

Following are selected case reports of postvaccination syncope in adolescents.

Case 1. A girl aged 13 years fainted within 10 minutes of receiving HPV and MCV4 vaccinations. She fell backward and hit her head on the carpeted floor of the clinic. The girl was admitted to the pediatric intensive-care unit because of skull fractures and subarachnoid hemorrhage. When VAERS contacted her approximately 6 months after the injury, she had recovered completely.

Case 2. A girl aged 16 years felt dizzy and had pallor within 5 minutes of receiving an HPV vaccination. While being escorted back to an examination room, she fainted, but the physician caught her as she fell. She was observed for 30 minutes in the clinic and recovered completely.

A total of 463 reports of postvaccination syncope during January 1, 2005-July 31, 2007 (Figure), were identified among persons aged >5 years, compared with 203 reports during 2002–2004. The rate of reports for postvaccination syncope among persons aged 25 years were as follows: 0.30 reports per million doses distributed in 2002, 0.35 per million doses distributed in 2003, 0.28 per million

:dditional information available at http://www.cdc.gov/vaccines/recs/acip!

eetings.htm#min. eports to VAERS can be made by anyone, including health-care providers, zalth departments, vaccine manufacturers, and members of the public. Any inically significant adverse events after vaccination can be reported; no confirmed usal relationship to vaccination is required. Limited mandated reporting exists r health-care providers; however, vaccine manufacturers are required to report | adverse events that have been reported to them. Typically, such reports to anufacturers originate from health-care providers. Published studies indicate at underreporting to VAERS varies but that events judged by the reporter to be rious are more likely to be reported (6).

Available at http://www.meddramsso.com/mssoweb/index.htm. Narrative descriptions of VAEs are coded using MedDRA coding terms.

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