The evolution of breast implants: from Houston’s origins to cutting-edge innovations
Breast implants have come a long way since their inception, evolving in both cosmetic and reconstructive surgery. Few people realize that the history of breast implants is deeply tied to Houston, where the first silicone implant was developed in the 1970s. With advancements in technology, materials and safety, breast implants have transformed over the decades, improving outcomes for patients seeking cosmetic enhancement and those undergoing breast reconstruction after cancer.
The Houston connection and the first breast implant
The modern breast implant originated in Houston in the 1970s when a local silicone manufacturer developed the first silicone breast implant. The very first patient to receive a breast implant was followed up 40 years later by Dr. Larry Hollier, professor of surgery, orthopedic surgery and pediatrics, who published a study detailing the long-term effects. Early implants were made with industrial-grade silicone, but as medical technology advanced, manufacturers introduced safer, medical-grade materials designed for long-term use in the body.
“Houston has played a pivotal role in the history of breast implants,” said Dr. Sebastian Winocour, professor and associate chief of the Division of Plastic Surgery. “From the very first silicone implant to today’s cutting-edge innovations, our city has been at the forefront of this field.”
FDA regulation and the evolution of implant safety
When the U.S. Congress passed the 1976 Medical Device Amendments to the Federal Food, Drug and Cosmetic Act, breast implants were classified as moderate-risk (class II) devices. However, concerns about implant safety arose in the 1980s, particularly regarding silicone gel-filled implants. Reports of local complications, cancer and connective tissue diseases led the FDA to reclassify breast implants as high-risk (class III) devices, requiring manufacturers to provide data demonstrating their safety and effectiveness.
In 1992, the FDA determined that manufacturers had not adequately addressed concerns about complications such as implant rupture and silicone leakage. Following the advice of an outside expert advisory panel, the FDA removed silicone gel-filled implants from the market, allowing their use only for reconstruction after mastectomy, congenital deformities or replacement of existing implants under controlled studies. During this time, saline-filled implants remained available as an alternative.
A turning point came in 1999 when the Institute of Medicine released a comprehensive report concluding that while local complications were a primary safety issue, there was no evidence that silicone breast implants caused systemic health effects such as cancer or autoimmune disease.
Generations of breast implants: From liquid to cohesive gel
Over the years, breast implants have gone through multiple iterations to improve strength, quality and feel. The most significant breakthrough came about 15 years ago with the transition from liquid silicone gel to cohesive gel implants, often referred to as “gummy bear” implants. Unlike their predecessors, which could rupture and allow liquid silicone to migrate to the lymph nodes, cohesive gel implants hold their shape even if ruptured. The recommendation for ruptured implants also has evolved – previously, removal was standard, but now, if a patient is asymptomatic, removal may not be necessary.
The latest innovations: The rise of 6th generation implants
Until recently, only two manufacturers dominated the breast implant market. However, in September 2024, the FDA approved a third manufacturer, introducing what is being marketed as the “sixth generation” implant. This implant features a new type of silicone and a microtextured surface, which may reduce rupture rates and minimize scar tissue formation around the implant. While these implants have been used in Europe for 15 years, their introduction to the United States is expected to push other manufacturers to innovate further.
“The approval of a new implant manufacturer is exciting because it drives competition and encourages advancements in technology,” Winocour said. “Patients will continue to benefit as implants improve and become more durable, natural-looking and safe.”
Breast implants remain one of the most extensively studied medical devices, with decades of research supporting their safety and effectiveness. The arrival of new manufacturers and evolving technologies continues to drive innovation, improving both aesthetics and safety to enhance outcomes for patients.
By Tiffany Harston, senior communications associate in the Michael E. DeBakey Department of Surgery
