Injectable Silicone and the Foot: A 41-Year Clinical and

Histologic History
SOI. W. BAUGN, DPM
Dep,,rtment of Orthopaedics, Podiatry Section, Los Angeles County, University of Southern California lv!edical Cente1;
Glendale, California

BACKGROUND. Since 1964, the author has lnvestigated injectable gical and postmortem specimens were gathered for histologic
liquid silicone as a soft tissue substitute for the loss of plantar fat. analysis.
This form of fatty tissue depletion over the sole is closely linked RESULTS. There was no evidence of significant adverse response in
to a common painful \Veight~bearing foot disorder, metatarsal- long~term clinical follow-up. Silicone specimens studied by two
gia, and to painless diabetic foot ulcers. departments of pathology found 110 inflanunation,. infection,
ORJEL'TIVES. To present the history of injectable silicoflet corpo- allergy, or granulornas.
rate interest, individuals who helped pursue approval, lts mis- CONCLUSIONS. Medkal Fluid silicone appears to be safe, effective,
uses, and events that have delayed its availability. and stable biomaterial for treating weight-bearing loss of plantar
MATERlAT,S AND METHODS. Dow Corning f'.-0rporation's 360 Med- fat. Trademarked PodiSil (Richard-James Inc., Peabody, MA,
ical Fluid of 350 ccntistoke was injected beneath corns and cal~ USA), a 350-centistoke injectable silicone has been approved for
!uses .in 1,585 patients. Diabetic neuropathic foot ulcers were marketing in Europe for the prevention of diabetic foot ulcers.
injected after healing in an effort to prevent their recurrence. Sur-

SOL W. BALK[N, DPM, HAS INDlCATED NO SIGNIFICANT INTEREST WITH COMMERCIAL SUPPORTERS.

The Clinical Problem A Critical Causation Factor

Human feet traverse 100,000 miles in a 75-year life span, The cumulative effects of excessive weight-bearing forces
so it is understandable that forefoot plantar pain- in both painful and painless feet are linked to a localized
metatarsalgia-is the most common pressure-related foot loss of essential adipose tissue. [n feet with sensory pro-
disorder. When indudh1g lesser digits, about 5% or 15 tection, a lack of planrar fibrofatty padding leaves
million adults in the United States have trouble with corns 1nicroneural and pressure-sensitive pacinian corpuscles
or calluses. unprotected from the gouging effects of bone. Fat pad
Feet that lack the warning sign of pain, as with diabetic depletion results in weight-bearing pain that ranges from
neuropathy, develop painless corns or plantar calluses that moderate to intolerable. A decrease in plantar fat in the
become painless ulcers and are epidemic in scope. Skin neuropathic foot places the patient at risk of wounds that
insensitivity and high peak pressure points are implicated can remain open for months or years. The key to relieving
in 80% of 100,000 diabetic lower extremity amputations pressure-bearing pain or preveming or healing a plantar
yearly in the United States. Early problems go unnoticed ulcer is pressure reduction, Over-the-counter re1nedies,
because people without pain rarely look at the bottoms of professionally made in-shoe supports, and special shoes
tl1eir feet. Calluses and forefoot wounds are further over- are mostly ineffective when dealing wirh forefoot pain or
looked because many physicians also fail to examine ulceration owh1g to fat pad atrophy.
patients' feet. :vl:edical professionals can help reduce the
amputation rate by requiring that diabetic patients remove
Animal Studies
their shoes and stockings. In a l-n1inute examination, the
digital and plantar surfaces of both feet can be tested for The Dow Corning Corporation stated that it would inves-
lack of skin sensation and the presence of painless corns, tigate only 360 Medical :Fluid of 350-centistoke viscosity
calluses, bunions, or hammer toes. Any of these may be as used in their facial study. In 1967, the Medical Research
silent signs of impending ulceration-or worse. Committee at Cedars-Sinai Medical Center, Los Angeles,
California, USA, approved an animal research proposal of
mine. At their vivarium, Charles A. Carton, a clinical pro-
fessor of neurological surgery at the UCLA :vl:edical Cen-
ter, Los Angeles, permitted the injection of silicone into the
Address correspondence and reprint requests to: Sol W. Balkin, pads of 40 dogs under his study. Dr. Carton wa.s investi-
DPM, 229 North Central Avc-nue, Suite 610) G[endale) CA gating end-to-end blood vessel anastomosis for eventL1al
91203-,2587, or e-mail: swbaUdn@sbcglobaJ.nc>t. use in brain aneurysms. Under general anesthesia, the cen-

2005 by the American Society for Dennatologic Surgery, foe, • Published by BC De.:ker Inc
1076...()512 • Dermatol Surg 2005;31 ;1SSS·-1560.
Derma to/ Surg 31: 11 Part 2:November 2005 BALK!N, INJECTABLE SILJC0NE AND THE FOOT 15 5 9

diabetic foot ulcers. Efforts arc under way to seek federally illness arc unable or unwilling to change hody position,
authorized diabetic foot studies in the United States. making them vulnerable to tissue breakdown. Similar to
humans, loss of soft tissue between skin and bone is a risk
factor that places the weakened animal at risk.
Results
i\ckrzowledgments tviy thanks to the patients who consented to
Between April 1964 and January 2005, 1,585 of my receive silicone injections, especially those who agreed to post-
patients with 4,000 to 5,000 cligital or plantar sites mortern specimen removal for histologic study, A special thanks
received 25,0Q0 recorded silicone injections. Long-term is extended to Leo Kapian. Aiso~ my gratitude, to Robert Rylee,
follow-up indicates that 60 to 80% experienced moderate Eldon Frisch, Howard Marshall, Charles Carton, Andrew J. M.
ro complete pain relief and elimination of calluses. Fifty Boulton, Scott Nelson, Diane and Wayne Richard~ and many
percent of plantady injected sites treated for pain required others who provided guidance and assistance. Their help made it
one or multiple booster injections 1 to 20 years following possible for PodiSiJ to come to market in Europe, Although the
the original silicone implants. work of Drs. Sakurai and Kagan ultimately produced serious
problems: they must also be acknowledged because of giving rise
Some local and generally asymptomatic fluid migration
to medically useful injectable silicone. This scientific experience
occurred in a few overinjected feet, rarely reqniring surgi-
has received the close support of my wife of 46 years, Janelle
cal removal. Nu other complications, such as tumors, Balkin. She contributed greatly to clinical application, published
infection, inflam1nation, rejection, or aHergic response, articles, and book chapters and has made this 41-year adventure
have been observed. one of fulfillment.
A lack of significant adverse responses is attributed to
having used only Dow Corning 360 Medical Fluid Sili-
cone after the initial 50 patients received the Sakurai fluid. References
The singular complication observed in a fow was a per-
1. Balkin SW, Plantar keratoses; treatment by injectable liquid silicone:
sistent distinct purplish-brown skin discoloration. In up to report of an 8-year ex:perience.Oin Orthop 1972;87:235-47.
20 years of follow-up in these patients, the skin color light- 2. Sperber PA. Treatment of the aging skin :rnd dermal defects. Spring-
ened but did not return to normal. No skin color changes fidd {IL): Charles C, Thomas; 1965.
were seen with the Dow 360 Medical Fluid. 3, Kagan HD. Sakurai injectable sili.;onc formula. Arch Otolaryngoi
J963;78,663-8.
4. Spanbauer JM. Breast implants as beauty rirual: woman's sceptre
Additional Potentially Valuable Uses and ptison. Yale J Law Feminism 1997;9:157-205.
5. Assembly Bill 36, Chapter 82, Statutes of Nevada1 1975.
Of equal or greater importance than investigating silicone 6. Senate Bill 77, Chapter 111t Statutes of Nevada, 1987.
for diabetic foot ulcers is its use for decubitus ulcers, also 7, Fox LP, Geyer AS, Husain S1 et al. M)1cobacterium abscessus and mul-
tifoca! abscesses of the breasts in a transsexual from illicit intraurnn,-
termed _pressure sores, which have existed since antiquity.
mary injet.'tions of silicone. J Am Acad Deimatul 2004;50:450--4.
Countless devices and topical agents bave been tried, as S. Rae V, Pardo RJ) Blackwelder PL, Falanga V. Leg ulcets following
well as plastic and reconstructive surgery. These debilitat- subcutaneous injection of a liquid silicone pl'ep.:iration. Arch Dct-
ing wounds occur in the bedridden and neurologically matol 1989;125,670-3.
impaired and in hospitalized patients, including children. 9. Masttuserio DN, Pesqueira MJ, Cobb MW, Severe granulomatous
:renction and facial ulceration occurring aftef subcutaneous silicone
It has been suggested that by creating a subdermal soft tis-
inje,ctlon. J Am Acad Dermatol 1996;35(5 Pt):849-Sl.
sue prosthesis, injectable silicone has the unique potential 10. Achauer BM. A serious complication following medical-grade sili-
to prevent pressure sores. 15 Subcutaneous injections would cone injection of the face. Plast Reconstr Surg 1983;71:251-4.
be given at the earliest sign of impending skin breakdown, 11. Balkin SW, Kaplan L Jnjectabic silicone and the diabetic foot: a 25-
blanching erythema. Commonly involved sites are ischial year reporL Foot 1991;2:83-8.
12. Wallace \XTO, Balkin SW, Kaplan L, NL·lson SD, Tile histological host
tuberosities, the sacrum, rhe greater trochante½ and the
response of liquid silicone injections for preveJJtion of pre.~snn:>
back of the calcanens, where prolonged bony pressure related ulcers of the foot: a 38Myear study. J Am Podiatr Med Assoc
induces ischemia and soit tissue necrosis. Histologic find- 2004;94,550-7.
ings in the foot show that microdroplcts of liquid silicone 13, Angdl .M. Science on trial: the dash of medical evidence and rhe law
encircle and cushion small arteries, capillaries, and nerves. in the breast implant case. New York: W.W. NortmJ & Company;
1996.
Tl1eoretically, this encirclement could reduce pressure
14. van Schie CHM, Whaley A, Vi!cikyte L, et al. Efficacy of injected sil-
from these bony pr01ninences. icone in the diabetic foot to reduce risk facrors for llkerntion: a ran-
Beyond the enormous monetary aspect of treating sev- domized double-bhnd placebo-controlled trial. Oiabett'S Care
mill1on patients with these wounds annually, the phys- 2000;23,634-8.
ical and emotional cost to the patient, family, and others 15. Balkin S, Kaplan L Silicone injection management of diabetic foot
ulcers: a possible nwdcl for prevenrion of pressur~ ulcers. Dccubitus
is very great. Authorized investigation is warranted.
199) ;4(4 j,38-40,
Decubitus ulcers are also a major problem of veterinar- 16. Swaim S1'~ Hanson RR Jr, Coates JR. Dccubitus ulcers in animals. In:
ians in both small pets (dogs) and large animals (horses), 16 Parish LC:, Witkowski JA, Crissey JT, editors. The decubitus ulcer in
v,,u,uuucu animals and those convalescing fr0111 injury of clinical practice. New York: Springer; 1997. p. 217-38.
 Oermato/ Surg 31: 7 7 Part 2:November 2005
15 60 BALKIN, INJECTABLE SILICONE AND THE FOOT

perspective to the use of silicone while exorcising media-

Commentary
fueled demonology, which has made silicone the target of
This timely and extraordinarily important article documents the unfounded bias and millions of dollars worth of litigation.
efficacy of liquid silicone injections for weight-bearing abnor- This is a rare article that illuminates the forces (profit, effi-
malities that Untreated in diabetics are a contributory factor in cacy, and legal liabilities) that impart momentum or inertia to
80,000 lower extremity amputations yearly in the United States the integration of promising therapies.
alone. In addition, Dr. Balkin offers persuasive arguments that 3. To give credit where it is due, at the end of this one man's 40-
suggest that this therapy is clearly superior to any currently avail- year odyssey there was no pot of gold. There were no speak-
able techniques. If employed worldwide, this modality may spare ing engagements or any type of financial considerations in his
thousands of individuals from mutilative surgery or lifelong dis- development of this therapy. All of his work was done
ability. Several other issues are particularly noteworthy: because Dr. Balkin believed that it was the right thing to do.
1. The evidence is impressive from the standpoint of study size, Aside from being a milestone in the reevaluation and inte-
duration, and histologic verification. To my knowledge, there gration of a particularly humane therapy, this article is ates-
has never been an article regarding silicone for soft tissue tament to the man who did it to relieve human suffering. I am
augmentation with the scientific validity or therapeutic impli- honored to be asked to review his work.
cations presented here.
DAVID DUFFY, MD
2. Dr. Balkin's chronologic outline of the highs and lows in his
attempt to promote this therapy confer an orderly historical
Torrance, CA