A Brief History of Silicone and Saline Breast Implants
Implant Generations
Silicone gel breast implants are the most commonly used breast prosthesis worldwide. They have been available since 1963, and have evolved dramatically
over the last 40 years. Understanding the history of the development of these devices is important when you are considering any type of breast implant.
The age, and the generation or type of breast implant is important, because more complications are associated with earlier generation devices. The organization
of silicone implants into generations aids in understanding the evolution of these devices and the improvements in complication rates over time.
First Generation breast Implants
The first generation of silicone gel implants corresponds to devices developed in the 1960's. These include the original silicone implant manufactured by
Dow Corning from 1964 to 1968. These earliest devices were characterized by Dacron patches, which were placed on the posterior wall. They were produced until
the early 1970's and the most common complications were capsular contracture (hardening and distortion of the breast implant caused by scar tissue) and rupture.
Explanted 1st Generation Implant-1969
Second Generation Breast Implants
The second generation of implants was also produced by Dow Corning, from about 1972 until 1986. These devices were modified with a thinner shell and less viscous
or thinner, more liquid gel. In addition, the patches were removed. These changes did not, however, reduce capsular contracture rates.
2nd Generation Device 1973
Third Generation Breast Implants
In the early 1980s, third generation devices were introduced and were characterized by thicker, reinforced barrier shells.
These properties are still found in fourth and fifth generation devices today.
3rd Generation Device 1984
Fourth and Fifth Generation Breast Implants
The modifications found in fourth and fifth generation implants are primarily changes in the silicone gel technology. The cross-linking of the gel molecules
produces the cohesiveness that gives an implant its characteristic feel. The round gel implants that are now FDA not the same as the approved in the United States
are cohesive gel devices; however, these are newer form stable highly cohesive gel implants.
Often referred to as fifth generation implants, the form stable highly cohesive gel implants differ from the round gel implants in that the gel has been further
cross-linked to provide more firmness. This helps the implant maintain its shape and prevent the upper pole of the implant from collapsing. The first of these shaped
devices were introduced in 1993 and have become one of the world’s most popular breast implants. The newest generation includes the Inamed style 410, and Mentor's CPG
device, both of which are currently undergoing clinical trials in the United States.
Saline Breast Implants
Saline breast implants were first manufactured in 1964. The earliest devices had high deflation rates but modifications in the design of the shell allowed the
development of the modern saline implant. Although all saline implants will eventually deflate, the deflation rate varies by style, manufacturer, and surgical technique.
Very low deflation rates were reported by Inamed Corporation and Mentor Corporation in their respective large, simple trials. The failure rate may be affected by the
overfilling or underfilling of saline implants at the time of the surgery. Because of the eventual deflation of saline implants and the clinical effectiveness and safety
of fourth and fifth generation silicone implants, silicone is now preferred over saline by most patients and physicians worldwide.
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