Articles Provided by Dr. Glicksman of Monmouth County

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Form stable highly cohesive gel implants differ from the recently FDA approved standard round gel breast implants that are currently available in the United States. These implants, given the nickname “Gummy Bear” implants, are the newest generation of silicone gel implants and differ with respect to both the consistency of their fill and shape. Developed in 1993, and used widely throughout Europe and Canada, they remain in clinical trials in the United States. Three corporations are currently enrolling patients in their trials: Allergan, formerly Inamed, Mentor, and Silimed, now called Sientra. Although each of these manufacturers has developed a highly cohesive gel implant, they each differ considerably. I presently am enrolling patients in the Allergan style 410 study and the Allergan style 410 CARE study. Because the value of these studies is so significant, each manufacturer has selected a small number of surgeons to receive specialized training in the use of these devices, before allowing the surgeons to enroll patients for study. In the United States there are presently two groups of patients who may enroll in a clinical trial with the highly cohesive breast implants. The first group are women who request a revision breast augmentation or breast reconstruction after mastectomy (CARE study), and second, are those women who desire a primary breast augmentation (410 implant study). All patients must agree to return for follow–up exams for a period of 10 years from the date of their surgery.

Frequently Asked Questions (FAQ)

How are form stable highly cohesive breast implants different from standard round gel implants?

Cohesively: The more cohesive silicone gel is, the thicker and firmer it becomes. This explains why silicone can come in a liquid form in your hair gel as well as the solid form in your kitchen cutting board or pot holder. There is a range of firmness within silicone products, and the highly cohesive gel implants are believed to be just firm enough to resist forming creases and folds, yet soft enough to feel like a natural breast. This increased form stability also reduces implant visibility and palpability through the overlying breast tissue and skin.

Shape: The form stable highly cohesive gels that are presently available in the United States are shaped devices. This means that they have a variable width, height, and projection. The main advantage to a shaped device is that it offers the surgeon more options in selecting an implant that can fit your individual body shape and size, as well as the quality of your breast tissue. No one breast implant is the right one for all women. Some may still prefer the fuller look of a round implant while others may prefer the more natural teardrop shape that the form stable highly cohesive gel implant can offer.

Rupture Rates and Capsular Contracture: The most recent data collected from the United States and Canada shows extremely low rupture rates with the form stable highly cohesive gel devices. The long-term European data demonstrates very low capsular contracture rates. More data will continue to be collected over the next 10 years, but to date, no other device has demonstrated such low rupture rates.

Will I need a larger incision if I choose form stable highly cohesive gel implants?

Because these implants cannot be folded on themselves, the surgeon must use a slightly larger incision to place these implants into the body without damaging them. I usually use an inframammary incision which is well concealed under the breast.

Do I need to have an up-to-date mammogram prior to undergoing this procedure and what screening techniques are used after?

Mammography and MRI: Your breast health has been, and will always be my number one concern. Pre-operative mammography is required on all patients over 35 and as directed by the American Cancer Society guidelines thereafter. After breast augmentation, specialized views may be necessary for women with breast implants. Presently, an MRI is the best technique routinely available for evaluating the integrity of breast implants, but newer ultrasound techniques are on the horizon.

How can I enroll in a form stable highly cohesive gel breast implant study?

Until their approval in the United States, patients must enroll in a FDA approved long-term study. As a requirement of these studies, all patients must return for annual office visits. It is suggested that you live in the tri-state area, New York, New Jersey, or Pennsylvania, if you wish to participate. For patients who move out of the area, every effort is made to find a 410 cohesive implant study physician to ensure your long-term follow-up. You can contact us for more information or to schedule an appointment.

Revision Surgery for Problem Breast Implants

Revision Saline to Gel Breast Implants

Revision Surgery for Old Silicone Gel 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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