Silicone Injections
Silicone injections have a long history, dating back to the 1940s when they were first used for breast augmentations in countries like Japan, Switzerland, and Germany. Initially, these injections gained popularity due to their non-surgical nature, appealing particularly to performers such as topless waitresses and showgirls. Despite being approved by the FDA for specific medical conditions, such as hemifacial atrophy, complications began to arise from illegal breast injections in the 1960s. Women reported severe side effects including painful nodules and inflammation, leading to conditions like silicone mastitis, which often required surgical intervention.
By 1967, heightened awareness of adverse reactions prompted the FDA to take action against manufacturers like Dow-Corning, resulting in increased regulation of silicone as a medical device. Despite this, reports continued to surface regarding complications from both medical and industrial-grade silicone. The FDA's growing concern led to warnings against silicone injections, particularly for cosmetic purposes, emphasizing the need for skilled practitioners and limiting usage to extreme medical cases. This complex history reflects a broader conversation about the safety of cosmetic procedures and the ongoing quest for effective and safe augmentation methods.
Silicone Injections
An injection of silicone into the face or breasts for corrective or cosmetic purposes. Though human use was restricted, many illegal injections were performed. Complications including silicone migration and painful cysts surfaced, often years later.
Origins and History
Silicone fluid with additives had been injected for breast augmentations since the 1940’s in Japan, Switzerland, and Germany. Additives were thought to lock the inert silicone into the injected area by inducing the formation of fibrous capsules. Most injections were performed by physicians or cosmetologists. Injections gained popularity, particularly among topless waitresses and showgirls, because they did not involve the cutting, hospital stay, and expense of surgical augmentation.
In 1965, Dow-Corning received Food and Drug Administration (FDA) permission to investigate injections of silicone fluid for soft-tissue augmentation. Breast augmentation was forbidden, but the substance was deemed promising for rare, disfiguring conditions that affected the face and body such as hemifacial atrophy and lipodistropy. Dow’s seven investigators followed a closely supervised protocol in working with more than thirteen hundred patients and tracked their progress into the 1970’s. They reported few side effects and both cosmetic and psychological benefits.
In the 1960’s, women began to report complications from illegal breast injections. The breasts developed solid, painful silicone nodules; occasionally the silicone would migrate along the needle track of the injection. The inflammation and incapacitating pain, called silicone mastitis, could be relieved temporarily by antibiotics and anti-inflammatory agents, but it often returned. For lasting relief, the silicone gel had to be removed using a stab incision. In two reported cases, the patients’ swelling and pain were so severe that physicians removed part or all of the breasts. Complications sometimes arose five to nine years after the injections. Patients were told that their reactions were to the silicone; however, the Dow-Corning investigators maintained that the additives were responsible.
Impact
In August, 1967, after examining several cases of adverse reactions to silicone injections, the FDA initiated criminal proceedings against Dow-Corning for illegal shipments of silicone fluid. Company officials maintained that medical-grade silicone was shipped only to the seven authorized investigators and to people who signed an affidavit promising it would not be used on humans. They believed the problems probably arose from use of industrial-grade silicone fluid shipped by Dow and three other companies which could contain lint, dust, and metal fragments. The FDA suspended its approval for human experimentation by Dow-Corning in November, 1967.
Subsequent Events
The FDA began regulating silicone as a device rather than as a drug in 1976. Also that year, Las Vegas physicians published an account of their experiences with local women who had received silicone injections. They estimated that twelve thousand Las Vegas women had been injected, and 1 percent reported problems each year, some traceable to medical-grade silicone. They urged that silicone be avoided except by skilled practitioners in extreme cases such as hemifacial atrophy. In 1992, the FDA obtained consent decrees from three New York physicians stating that they would no longer inject patients with silicone fluid as treatment for acne scars and wrinkles. These injections were causing the same side effects that breast injections had.
Additional Information
A detailed discussion of the side effects seen by Las Vegas physicians appears in “Complications of Silicone Injections,” by Edward H. Kopf, Rocky Mountain Medical Journal 73, no. 2 (March-April, 1976).