Breast augmentation, a procedure using foreign materials to enhance or reconstruct the breast, spans over a century. While the idea of augmentation is old, the modern, standardized medical device has a specific starting point in the mid-20th century. The evolution from crude, often dangerous injections to today’s highly engineered implants marks a significant journey in medical innovation and patient safety.
Early Attempts at Augmentation
Before the development of a contained implant, surgeons in the late 19th and early 20th centuries experimented with injecting various substances directly into the breast tissue. In 1889, for instance, a surgeon attempted augmentation using injections of paraffin and Vaseline, which quickly led to severe complications. These materials often caused chronic, severe inflammation and hardening of the breast tissue, a condition known as paraffinoma.
Other attempts involved implanting a bizarre array of foreign objects, including ivory, glass balls, ground rubber, ox cartilage, and various sponges. These crude materials were associated with high rates of infection, rejection, and disfiguring results. In the 1890s, surgeons began using a patient’s own tissue, such as a benign fatty tumor (lipoma), for breast reconstruction. Although autologous fat grafting was a safer alternative, the transferred fat was often reabsorbed by the body, limiting its effectiveness for permanent augmentation.
The Introduction of the Silicone Implant
The search for a safer, more predictable method culminated in the invention of the first modern breast implant in the early 1960s. American plastic surgeons Dr. Thomas Cronin and Dr. Frank Gerow, in collaboration with the Dow Corning Corporation, developed the device. The design consisted of a strong, flexible silicone elastomer shell filled with a viscous silicone gel. The first successful augmentation using this new device, known as the Cronin-Gerow implant, was performed in 1962.
The first patient was Timmie Jean Lindsey, who agreed to the surgery in 1962. This new implant was a breakthrough because its encapsulated design prevented the filler material from migrating into surrounding tissue, addressing a major complication of earlier injection methods. The silicone gel was chosen for its inertness and its ability to mimic the soft feel of natural breast tissue.
Evolution of Implant Technology and Safety
Following the 1962 breakthrough, implant technology began a long process of refinement and diversification. French manufacturers introduced the first saline-filled implant in 1964, offering an alternative that used a sterile saltwater solution within a silicone shell. This saline option provided a safety benefit, as the body could harmlessly absorb the solution if the shell ruptured.
The late 20th century brought increased scrutiny and regulatory involvement concerning the safety of silicone gel implants. The U.S. Food and Drug Administration (FDA) initially classified implants as moderate-risk devices in 1976, but concerns about rupture led to a temporary restriction on silicone implants for cosmetic use in 1992. This regulatory review spurred manufacturers to develop improved designs, including thicker shells and different surface textures. The FDA lifted the restriction on silicone implants for cosmetic use in 2006 after extensive clinical studies confirmed their safety and effectiveness.
This period also saw the development of highly cohesive silicone gel implants, often called “gummy bear” implants. This form-stable gel maintains its shape even if the implant shell is compromised, representing a major advancement in device integrity. Today’s implants are the result of decades of innovation, moving from a single design to a variety of highly engineered devices subject to stringent safety standards.