Highly cohesive gel breast implants finally received FDA approval in 2013 after more than 12 years of clinical study in the United States. These implants are used in breast augmentation, breast reconstruction, and breast implant revision procedures. Highly cohesive gel implants are sometimes nicknamed, “Gummy Bear” implants and they differ in several ways from the round silicone gel breast implants that were FDA approved in 2006. Developed in the early 1990’s, the Natrelle® style 410 highly cohesive breast implant, manufactured by Allergan, has become one of the most widely used breast implants around the world. Mentor and Sientra, two other manufacturers in the United States, also manufacture shaped, silicone gel breast implants. Although each of these manufacturers has developed a shaped breast implant, they differ from each other with respect to the consistency of their silicone gel fill (cohesivity), their shape, their shells, and the percentage of gel that are each filled with.
Although shaped highly cohesive gel breast implants may be new to many US plastic surgeons, they are not new to Dr. Glicksman. As a Principle investigator for Allergan, Dr. Glicksman underwent extensive training in Sweden before being given the opportunity to enroll her patients in clinical trials in 2004. Since then she has placed thousands of shaped highly cohesive gel implants for primary breast augmentation, revision augmentation, and breast reconstruction after mastectomy.
How do highly cohesive breast implants differ from the standard round gel implants or the new round Natrelle® Inspira implant?
Cohesivity: The more cohesive silicone gel is, the thicker and firmer it becomes. This explains why silicone can come in a liquid form, like what is found in hair gel, as well as a solid form similar to a kitchen cutting board. There is a wide 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. Each of the different manufacturers, Allergan, Mentor, and Sientra, has designed highly cohesive breast implants with different degrees of cohesivity. The benefits of this increased cohesivity or form stability include reduced implant visibility and palpability through the overlying breast tissue and skin.
Shape: The newer highly cohesive gel implants offer plastic surgeons and their patients the ability to select shaped breast implants that have a variable width, height, and projection. The possible advantage to a shaped device is that it offers more implant options that may fit an individual body shape and size. The variable projections available are especially useful for patients with breast or chest wall asymmetries, or patients with tuberous or constricted base breasts. While there is not one breast implant is the right for all women, the availability of shaped highly cohesive allows a more customized approach to modern breast implant surgery.
Rupture Rates and Capsular Contracture: The 10 year data collected from over 17,000 American women enrolled in the Style 410 studies in the United States, as well as the long-term studies completed in Europe and Canada, show rupture rates of approximately 10% at 10 years. The rupture rates are similar to those of the round gel implants.
Incision location and size: Because highly cohesive gel breast implants cannot be folded on themselves, they require an incision length adequate to allow them to be inserted without force or damage to the implant or shell. In some patients this incision may be 4-5 cm in length. Incision sites may vary, but it is generally recommended to use an inframmary fold incision to insert highly cohesive gel implants.
Mammography and annual screening techniques for patients over 40: Because a patient’s future breast health is Dr. Glicksman’s primary concern, all women over the age of 35 are required to obtain a pre-operative mammogram. After breast augmentation, mammography will require the addition of specialized views, called “Push-Back Views”. These additional views help the radiologist see more of the breast tissue after implant surgery. Presently, an MRI is the best technique routinely available for evaluating the shell of an implant and to look for ruptures, but much information can be obtained by a combination of ultrasound and mammography. Newer high-resolution ultrasound techniques are on the horizon.
Are highly cohesive breast implants ideal for all patients? There are advantages and disadvantages to all breast implants. A careful breast exam and lengthy consultation are necessary to determine which is the best implant for each patient. During the consultation an additional assessment of the breasts will be performed using the latest technology from Canfield Imaging: the Vectra 3D simulation. This imaging tool gives women the opportunity to visualize several different breast implant options in their own body, and most importantly, helps to create a better-educated patient. Dr. Glicksman has been using highly cohesive breast implants since 2004 and round gel implants since1992. This makes her well qualified to help guide you towards the safest, long-lasting breast implants possible.
For more information on the Allergan or Sientra highly cohesive cohesive gel implants: