Form Stable Highly Cohesive Gel Implants
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. The form stable breast implants are currently considered investigational devices in the US and are not yet FDA approved. 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, some of the manufacturers encouraged 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 form stable 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 scheduled follow-up exams for a period of 10 years from the date of their surgery.
Frequently Asked Questions
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 is being studied to determine if it will also reduce 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 possible advantage to a shaped device is that it may offer 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 very 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.
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 the implant shell or the cohesive gel. Incision sites should be discussed with the surgeon.
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 should be your primary concern. Pre-operative mammography is strongly suggested on all patients over 35 and as indicated 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 4-D ultrasound techniques are on the horizon.
How can I enroll in a form stable highly cohesive gel breast implant study?
Until their FDA 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 scheduled visits over a ten year period. Patients interested in enrollment can visit www.drglicksman.com or www.cohesiveimplants.com and click on "find a cohesive breast implant surgeon" to locate a principle investigator in your region of the country.
Are form stable breast implants ideal for all patients?
There are advantages and disadvantages to all breast implants. A thorough breast exam and lengthy consultation are necessary to determine the best breast implant for you. Patients also must meet the criteria for enrollment in the 410 study until the devices are FDA approved.
Caroline Glicksman, MD
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