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. Although the responsive round gel implants that were FDA approved in 2006  are cohesive to some degree, they are less cohesive than the newest highly cohesive gels approved in 2012 and 2013.

Often referred to as fifth generation implants, the 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 they have become one of the world’s most popular breast implants. The newest generation includes the Allergan style 410 and Sientra’s shaped and round highly cohesive breast implants, both of which are now FDA approved. Mentor’s CPG device remains in clinical trials in the US.

Highly cohesive breast implants manufactured by Allergan and Sientra are now approved by the FDA. Breast augmentation with these devices is more technically demanding. While thes implants may be new to many surgeons, Dr. Glicksman is both highly trained and experienced with the shaped highly cohesive gels.

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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