Treatment of facial atrophy with liquid silicone

Treatment

of Facial Atrophy

with

Liquid Silicone I

THOXIAS D. KEES, M.D.,New York, New York, AND FRANKLIN Los .I ngeles California

musculature and sometimes the cartilage and bone. Congenital hemiatrophy which is very uncommon is thought to be a separate entity from true progressive facial hemiatrophy. The deformity from Romberg’s disease can “burn out,” that is, become arrested at any time during its course. The deformities resulting from the condition have various degrees of severity, and the final deformity depends upon the stage at which progression halts. The familiar term “coup de sabre” refers to the sometimes sharp line of demarcation between normal and abnormal tissues, very similar to a sabre cut. Rogers [I] has collected about 1,035 cases reported since the middle of the nineteenth century. Of these only 670 were suitably documented to be included in his review as true cases of unilateral progressive atrophy. Other causes of unilateral or bilateral atrophy of the face are muscle wasting secondary to paralysis, congenital deformities such as the first and second branchial arch syndrome, and true lipodystrophy which is second only to Rornberg’s disease in frequency. Lipodystrophia progressiva (Barrayuer-Simmons disease) is characterized by a progressive loss of fat and subcutaneous substance which is symmetrical and bilateral. This distressing condition usually affects young girls and commences in the first decade of life. The head and neck regions are involved first; if the disease progresses, the advancement of subcutaneous atrophy is in a caudal direction. The upper part of the arms and torso are frequently involved. The cause of true lipodystrophy remains obscure; however, the same factors are present that have been implicated in Romberg’s disease, such as trauma, infection, and dysfunction of the sympathetic nervous system.

From the Department of S’urgery, Nezj York University School of Jledicine, New York, New 1~ork, and the Department of Surgery, Division of Plastic Surgery, C’niversity of California, School of Medicine, Los Angeles, California. This work was supported in part by a grant (GN-114%) .fronr the l=r2ited States Public Health Service. and by the Canrer Research Coordinating Conzmittee. Universit? of California, Los Angeles, California. Editor‘s iVote: The authors of this paper wish to point out that the silicone material (Dow Corning pure medical grade dinzethylp~~lgsilo.~(~ne 360 jluid. viscosity 3X centistokes) was obtained and used for the purposes stated herein under the FDd regulations for investigation of a new drug. It is beltersed that the noncontroversial nature of the treatment of Romberg’s disease as described in this article and the e.~cellent results obtained after the injection of the liquid stlic.one would make this report a worthwhile contribution to the .sl.tenti;fic literature. They wish to emphasize further, hoper, that even though preliminary experimental results in animals by university laboratory centers hazle been favorable and in the future this material may he a valuable addition to the @astir surgeon’s armamemzrium, puhliratinn of this paper in no way advorates the use of injectable silicone in human subjects until the laboratory and cllnic-al investigations by qualified investigators have heen completed and approved by the Federal Drug .-lrElnilzistratio?t.

ATROPHY iS an uncommon condition which is usually unilateral but can be bilateral. The most common form of facial atrophy is “progressive facial hemiatrophy,” which according to Rogers [1] was first reported by Parry in 182.5. This disease is commonly referred to as Romberg’s disease. In the great majority of reported cases it is unilateral although thirty-nine progressive bilateral cases have been reported in a total of 772 cases [I]. True facial hemiatrophy is not congenital and usually begins in the first or second decade of life. It is characterized by progressive wasting primarily of the skin and subcutaneous tissue of the face, but can also involve the underlying

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DIOPATHIC FACIhL

VOW. 111,

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L. ASHLEY, M.D.,

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B

FIG. 1. A, a moderate degree of facial herniatrophy in a fifteen year old Puerto Rican girl with severe emotional problems. B, the result after a total injection of 54 ml. of silicone given in divided doses of 6 to 10 ml. in a two month period. The injected right side of the face is normal to palpation after one year. Note that there is no interference with facial expression on smiling.

It is frequently difficult, if not impossible, to distinguish between bilateral Romberg’s disease and true lipodystrophy involving only the facial region. Indeed, this differentiation is academic since the management of these two related conditions is the same. Because of the severity of the cosmetic deformity and its psychosocial effects on the afflicted patient, plastic surgeons have frequently been called upon to correct these Established modalities of surgical conditions. treatment have been diappointing for the most part. Bone grafts to the maxilla and mandible are helpful in some cases but have a distinct tendency to be absorbed, very likely because of the tightness of the overlying atrophic soft tissues and skin. Free grafts of dermis fat have been the most widely accepted surgical technic- for filling out the soft tissue. These grafts also undergo marked shrinkage and absorption, particularly in patients with true Romberg’s disease. Early attempts to increase soft tissue bulk with various foreign substances including paraffin, petrolatum, vegetable oils, lanolin, and bees’ wax have resulted in foreign body reactions and severe scarring often with a more pronounced secondary deformity. These technics have been abandoned by most surgeons. In very severe

forms of the disease with marked thinning and shrinkage of the skin, it is sometimes necessary to provide extra soft tissue bulk with a pedicle flap. The disadvantages of this technic are obvious in that pedicle tissue from a distance can never re-establish a normal contour or color match of the surrounding facial tissues. The ideal subcutaneous tissue substitute for use in these patients should be soft, should not interfere with the muscles of facial expression, should not absorb or diminish with time, should restore normal or near normal contour, and should provoke minimal foreign body response in the local tissues (or preferably none at all), and should be systemically nontoxic. In the past five years we have used a simple, atraumatic, and flexible treatment which has fulfilled most of the aforementioned criteria. Outstanding results have been achieved without complication to date. This treatment consists of a series of subcutaneous injections of the involved area of the face with dimethylpolysiloxane (liquid silicone). Dimethylpolysiloxane is reported to have a high degree of thermal stability, is inert in the presence of many chemicals, and does not appear to change with time [2]. There is no substantiated evidence to date that it is or that granulomas can be carcinogenic Anwican

Joumal

oj Surgevy

Facial Atrophy

and Liquid

n

.\

523

Silicone

D

C

FIG 2. .1 and T3. a twenty-three year old woman (M. L.) with severe lipodystrophy of the face also involving the trunk. I’reviou5 dermis fat grafts to the face resulted in absorption. C and D. the result one year after multiple injvctions of silicone totaling 35 ml. The face is normal to palpation

produced by local injection of unadulterated silicone fluid, either in animals or human subjects. Dimethylpolysiloxane fluid is a liquid polymer whose molecular structure may be diagrammatically represented as : CH,

CHa I CHR---Si-----0 I CHI

~

(Sip0) [ CH,

CHa -Si

---CH,

1~x CH3

The medical grade of this fluid is known as Dow Corning 360 Medical Fluid and is prepared in many different viscosities measured in centistokes, the centistoke viscosity of water being 1. Silicone fluid has been the subject of study by several investigators. Rowan and Howley [3] have utilized it as a protective coating to the mucosa of the bladder for the relief of burning and frequency in chronic cystitis. They reported marked relief of symptoms after instilling it into the bladder. Armaly [P] replaced the aqueous and vitreous humor in the eyes of forty-five cats with this fluid. Control eyes were injected with saline solution. No inflammatory response or tissue reaction was noted in any of the eyes injected. Injected eyes could not be differentiated from the saline controls. After these animal experiments Armaly [4], after displacing the vitreous humor, injected silicone fluid into the eyes of five patients with refractory detachments of the retina. These injections were Vol. 111, April

1966

all successful. Almost identical results in thirtyeight rabbits’ eyes and in thirty-three human patients with retinal detachments were achieved by Cibis et al. [5]. These authors established that dimethylpolysiloxane fluid is tolerated in the vitreous cavity for as long as seven months. They were enthusiastic about its use in retinal detachment. Prachvabmoh and Eiseman [fi] used this material intrathoracically after thoracotomy to prevent pleural adhesions with good results. LABORATORY

STUDIES

Laboratory studies of tissue reactions to the injection of dimethylpolysiloxane fluid have been carried out in rats, mice, guinea pigs, rabbits, Rhesus monkeys, and Japanese apes [7-g]. The gross and microscopic findings in all of these animals are strikingly similar after the injection of both small and massive doses in single and multiple injections. Even after massive injections of as much as ten times the body weight of the animal, no evidence of adverse systemic toxicity has been found [8]. Biopsy specimens of the vital organs are still under study. After subcutaneous injection, the dimethylpolysiloxane fluid was found dispersed throughout the tissue planes. When massive doses were injected, the material was found to be encapsulated in delicate, thin-walled, spherical, or ellipsoid sacs. The silicone material itself appeared unaltered. The subcutaneous tissue surrounding these cysts was gray and semitransparent. Microscopic examinations of the skin and

Rees and Ashley

534

subcutaneous tissue at the site of injection carried out at intervals up to twelve months after injection have consistently shown an early mild inflammatory reaction with round cell infiltration which cleared within six weeks, leaving a mild fibrous cellular response containing a moderate number of histiocytes and a few lymphocytes. Six months after injection, the picture was very similar, showing the presence of a moderate degree of fibrosis and an occasional giant cell. The administration of massive doses of silicone has produced considerable alteration of the tissue structure of the subcutis. Fat cells surrounding these silicone cysts showed various degrees of atrophy, and the intracellular fat demonstrated small regular vacuoles in some areas, giving the tissue a “ground glass” appearance. These findings can be observed also in the omental fat and mesenteric fat in small animals receiving massive doses [S]. No local tumor or granuloma had occurred in the dermis and subcutis of these animals. No refractile bodies have been demonstrated with polarized light when the pure silicone was used. TECHNIC

OF INJECTION

It has been found preferable to inject the atrophic areas of the face with multiple small doses at weekly or biweekly intervals. The amounts injected rarely exceed 4 ml. at one time. The use of smaller volumes of this fluid rather than massive injections at a single sitting appears to be preferable both in avoiding overcorrection of the contour as well as in preventing the formation of silicone cysts. The skin of the face is thoroughly washed with pHisoHex@ and prepared with aqueous Zephiran@ solution. The injections are facilitated by the use of small amounts of local anesthesia such as 1 per cent Xylocaine.@ The local anesthetic can be used to raise a skin wheal at the site of penetration of the silicone needle, and small amounts of the local anesthetic can be infiltrated into the surrounding subcutaneous tissue. Care should be taken, however, to avoid the infiltration of large amounts of anesthetic which may distort the surrounding tissues. The dimethylpolysiloxane fluid is introduced into the anesthetized area by insertion of a No. 20 or 22 gauge needle. It is important that a lock type of syringe be used to assure firm fastening of the needle so that it cannot be dislodged with pressure. Two to 4 ml. are then infiltrated into an area

of the face while the needle is constantly moved to insure an even spread of the material beneath the skin, the so-called “fanning” technic. We have found it advantageous after injection to use a small. vibrator machine which disperses the fluid subcutaneously and prevents loculation. The total volume of fluid injected varies from patient to patient; however, in our series of fifteen patients the total amount injected did not exceed 40 ml. in any patient. After injection the patients are instructed to apply warm compresses to the face, particularly if any pain or discomfort is experienced in the ensuing hours. No specific analgesics or narcotics are required as the patient usually experiences little discomfort. COMMENTS

Although the immediate results of this treatment of facial atrophy seem most encouraging, it should be remembered that this technic is still investigative in nature and that much clinical and laboratory experience must accumulate before it can be accepted into the armamentarium of physicians. There is no doubt that the results so far achieved in the treatment of these distressing and difficult facial problems are far superior to those achieved by any other previous method. The patientsso treated have been unanimously enthusiastic about its use. This is particularly true of patients who have undergone previous surgery, such as dermis-fat-fascia grafts, only to have these grafts shrink or absorb into irregular nodular or cystic masses. Unquestionably, a technically easy procedure such as this one will be abused by some before the guidelines of therapy are clearly established. However, this should not result in premature condemnation of the technic as a whole. The long-term answer will be found in scrupulous documentation of all patients so treated and in long-term evaluation of the results, A possibility of the formation of secondary granulomas or tumors in patients who have been injected with small or large amounts of dimethylpolysiloxane fluid has arisen. A conservative attitude in this regard must be maintained. As far as is known there has been no documented case to date of either granuloma or tumor in a patient who has received injections of pure medical grade dimethylpolysiloxane fluid. * * Dow Coming MDx 4-4011.

series

#360-New

American

Terminology-

Journal of Surgevy

Facial

Atrophy

Cystlike nodularity and migration may occur if excessive amounts of the liquid are injected Experience has shown that at the same time. when the material is injected into the face it is preferable not to exceed a total dosage of 5 to (i ml. at any one time and that an interval of one to two weeks between injections is preferable. It is also important immediately after injection to massage the material carefully into the surrounding tissue in such a way as to disperse it, thus preventing the formation of isolated cysts. SUMMARY

series of fifteen patients with unilateral and bilateral atrophy of the face resulting from Romberg’s disease and lipodystrophy have been successful treated with multiple injections of dimethylpolysiloxane (silicone) fluid. The earliest patient in this group of fifteen has been followed up for five years. No single instance of untoward reaction to the silicone fluid has been noted either locally or systemically. This form of treatment has achieved results far superior to those of any previous known method of therapy for these unfortunate patients. Cntil further experience is gained with this modality of treatment, it must necessarily be considered of an investigative nature and should be undertaken only under carefully controlled conditions.

and Liquid

REFERENCES

3. ROI~AN, Ii. L. and HOWLEY, T. F. Observations on 4.

5.

A

Vol. 111, April 1966

.J;35

Silicone

6.

7.

8.

9.

the effects of dimrthylpolysiloxane in the human Nrw I-ork M. J., 63: 1357, 1963. bladder. of aqueous and AR~AI.Y, M. F. Replacement vitreous by silicone fluids. .4rrh. 0jAth., 68: 390, 196”. CI~IS, 1’. .I.. BECKER,M. I?., 0~~11, E., and CANAAN, S. The use of liquid silicone in retinal detachment surgery. Hull. Dow Corning Center for .-lid to Med. lies., 41: 13, 1962. PRACIIVABMOH,K. and EISEMAN, B. Silicone fluid in prevention of pleural adhesions. J.d .:\I. Thuilnnd, 47: 1, 1964. REES, T. D.. PLATT, J., and BALLANTYNE, D. L. An investigation of cutaneous response to dimcthylpolysiloxane (silicone) fluid in animals and humans 3 preliminary report. Plast. & IZeconslrzfrt. S~rc.. 35: 131. 1965. BALLANTYNE, D. L., REES, ‘I?. D., and SEIDMAN, I. Silicone fluid: response to massive subcutaneous injections of dimethylpolysiloxane fluid in animals. Plast. 3 Reconstruct. Swg., 36: 330, 1965. ASHLEY, F. L.. REES, T. D., BALLANTYNE. D. L., GALLO~VAY, D., MACHIDA, R., GRAZER, F., MCCONNELL, D. \‘., EDGINGTON,T., and KISKADDEN, W. An injection technique for the treatment of facial hemiatrophy. Plast. & Reconstruct. .Cztrg., 35: 640. 1965.