FDA Consumer March 1979 Question 9 Tab 3 Dg 2 New Face Lift Not All Smiles FDA has approved limited testing of liquid silicone by its manufacturer, Dow Corning Corporation, as a medical device for correcting severe facial disfigurement. Up to 300 people may participate in the tests each year and a specially trained group of doctors will carry out the testing. by Paula Klevan Napolean III's mistress, the Countess of Castiglione, physical beauty mattered above all else. At the age of 39, she shattered every mirror in her Paris apartment, then locked herself inside-vowing never to show her aging face in public again. Today, a century later, American men and women value youthful good looks just as the Countess did. But instead of hiding, many choose the route of facial cosmetic surgery. It is not only widely available, but is also attaining a new acceptance, even status, in parts of our society-witness the highly publicized operations of former First Lady Betty Ford and comedienne Phyllis Diller. The countless other people who undergo similar surgery have fairly routine variations on face-lifts, ear, eyelid, and nose operations. Results generally range from fair to excellent improvement of facial contours. A relatively new type of facial surgery is becoming increasingly popular throughout the United States. The procedure is liquid silicone injection. Thousands of people have received injections, hoping to smooth out wrinkles, crow's-feet, laugh lines, and acne scars. A national magazine reported recently that a prominent fashion designer sees his dermatologist twice weekly for the injections. Similar stories give the treatment an aura of faddish respectability. What the articles rarely tell are the possible consequences of forcing this clear, colorless, odorless substance into human flesh. These side effects first became evident in the 1960's, when liquid silicone injections became popular among women who wanted their breasts enlarged. The initial enthusiasm for the operation cooled rapidly as more and more women experienced serious and sometimes fatal complications. These included swelling, discoloration, cyst formation, and migration of silicone particles to the brain, lungs, or heart. Injection of liquid silicone into facial tissue can result in the formation of cysts, tumors, and granular masses. Even small amounts of the liquid silicone have the potential to clump and travel, blocking circulation, discoloing the skin, and eventually stretching the treated area so that it hangs in grotesque folds. The surgical procedures that are used to remove these complications are neither simple nor foolproof. Cutting occurs perilously near such vital structures as the facial nerve. Why should so dangerous a practice be considered medically sound? In fact, it is not. Despite its popularity, most liquid silicone surgery practices are condemned both by FDA and the American Medical Association. While surgery per se is outside FDA's jurisdiction, the drugs and devices used in such procedures are subject to FDA's regulatory author. ity. Sterile injectable liquid silicone is considered a medical device, and is subject to regulation by FDA under the Medical Device Amendments of 1976. This law gave FDA authority to set standards and require premar. ket clearance for medical devices. The major manufacturer of liquid silicone, Dow Corning Corporation of Midland, Michigan, has been conducting research during the past decade on the uses of this material for facial cosmetic surgery. In the spring of 1978, FDA approved a Dow Corning test program in which liquid silicone would be administered on a limited, nonprofit basis by a small group of physicians. The study will cover 3 years, followed by a 7-year followup on each patient. Some 250 to 300 people will receive treatment each year. Twenty-four doctors have been specifically trained in the administration of liquid silicone and in specialized postoperative care. Because of the great risk associated with injectable liquid silicone, only the most severe types of facial disfigurement will be considered for treatment under the Dow Corning experiments. These vary from a condition called facial lipodystrophy, in which the fat beneath the facial skin progressively shrinks away, to the branchial arch syndrome, characterized by the retention of gill-like ridges on the neck of the human fetus-a growth which normally disappears before birth. These conditions are rare; they are usually congenital and other methods of treatment are inadequate to correct them. The study guidelines specifically forbid the use of this device for minor imperfections such as frown lines. acne scarring, and other common facial aberrations. Distribution of liq. uid silicone beyond the auspices of the testing program across State lines is prohibited by FDA. Paula Klevan is on FDA's public af fairs' staff. Question 9 Tab 3 P3 3 FACT SHEET Liquid Injectable Silicone FDA regulates liquid injectable silicone as a medical device. FDA has not approved the marketing of liquid injectable silicone for use in treating minor facial defects such as wrinkles or breast augmentation because of questions concerning its safety and effectiveness. We know there are adverse effects associated with the injection of liquid silicone including material migration, inflammation and discoloration of surrounding tissue, and the formation of granulomas (nodules of _granulated inflamed tissue). Because injectable silicone has not been approved for marketing, any use of the device is legally confined to FDA approved investigational studies conducted according to guidelines prescribed by FDA regulations for significant risk devices. This means the device can be used only by health professionals and patients participating in clinical investigations that receive prior approval from FDA. If promoted and sold for unapproved medical purposes, liquid silicone may be seized and legal action taken against the supplier. Presently, FDA cannot assure the quality of liquid silicone used outside of an approved study. Inferior substances may greatly increase the risk of adverse reactions. Until data demonstrate that liquid silicone can be used safely and effectively, FDA's investigational device regulations are essential for the protection of human subjects. 1982 Question 9 Tab 3 PG In 1978, FDA approved one clinical study sponsored by the Dow Corning Company to investigate the use of liquid injectable silicone for treating severe facial deformaties such as hemifacial atrophy (a wasting away of one-half of the face), Lipodistrophy (facial emaciation), and branchial arch syndrome (a congenital underdevelopment of the cheek and jaw area). Dow has completed the study and is compiling clinical data for analysis and submission to FDA. FDA. approval for marketing injectable silicone as a medical device for correcting severe facial defects will be contingent upon the clinical data substantiating the device's safety and effectiveness. Although FDA has never approved the use of liquid.silicone for breast enlargement, even for clinical investigation, some physicians in the *even 1950's and 1960's did use liquid injectable silicone for breast enlargement. Serious injury and several deaths have been attributed to these injections. Reported reactions included severe pain, swelling, lumpiness (formation of nodules in the breast), discoloration, and infection. Surgical removal of the breasts has been necessary in some cases to prevent gangrene or potentially fatal migration of silicone particles from the breasts to the brain, heart or lungs. Overwhelming evidence of these dangers finally stopped the widespread use of liquid silicone for breast enlargement, although cases are occasionally still reported including resultant side effects. Question 9 Tab 3 P3 9 Standard paragraphs used to respond to consumer inquiries. SILICONE INJECTIONS 1. At present, medical grade liquid injectable silicone is not approved for the purpose of treating minor facial contour problems, or for any other plastic surgical purpose. The Food and Drug Administration (FDA) has not seen any scientific evidence that provides reasonable assurance that the product is safe and effective for this intended purpose. 2. Because injectable silicone has not been approved for market, any use of the device is legally confined to FDA-approved investigational studies, conducted according to guidelines prescribed by FDA regulations for significant risk devices. Under an approved Investigational Device Exemption (IDE), FDA allows a firm to conduct controlled studies using human subjects to collect the scientific evidence needed to assure reasonable safety and effectiveness for a medical device. If promoted and sold for unapproved medical purposes, liquid silicone may be seized and legal action taken against the supplier. Presently, FDA cannot assure the quality of liquid silicone used outside of an approved study. Inferior substances may greatly increase the risk of adverse reactions. 3. Until data demonstrates that liquid silicone can be used safely and effectively, FDA's investigational device regulations are essential for the protection of human subjects. 4. In 1978, FDA approved one clinical study sponsored by the Dow Corning Company to investigate the use of liquid injectable silicone for treating severe facial deformaties such as hemifacial atrophy (a wasting away of one-half of the face), lipodistrophy (facial emaciation), and branchial arch syndrome (a congenital underdevelopment of the cheek and jaw area). Dow has completed the study and is compiling clinical data for analysis and submission to FDA. FDA approval for marketing injectable silicone as a medical device for correcting severe facial defects will be contingent upon the clinical data substantiating the safety and effectiveness of the device for that purpose. 5. There is a collagen product, Zyplast, that has been recently approved for the purpose of treating minor facial contour problems. You may wish to inquire about the availability of this product by writing to Collagen Corporation, 2455 Faber Place, Palo Alto, California 93403. 6. We are aware that some medical practitioners continue to use medical grade liquid silicone in their dermatology practice. FDA does not regulate the practice of medicine, leaving that up to State licensing boards. However, you should know that if you submit to a treatment with full knowledge that it involves an unapproved device and that the treatment is not associated with an approved investigational device exemption, you are doing so at your own risk. Question 9 Tab 3 pg 10 7. If you should need more information, contact the Division of Surgical and Rehabilitation Devices (HFZ-410), Office of Device Evaluation, Center for Devices and Radiological Health, 8757 Georgia Avenue, Silver Spring, Maryland 20910, (301) 427-7156. Revised: 08/15/86 Resources FDA Consumer, "New Face Lift Not All Smiles" (March 1979) |