Highly cohesive gel breast implants finally received FDA approval on February 20, 2013 after more than 12 years of clinical study in the US. Highly cohesive gel breast implants differ from the round breast implants that were FDA approved in 2006. These implants, which have been given the nickname “Gummy Bear” implants over the years, are the newest generation of silicone gel breast implants. In March of 2012, Sientra became the first US manufacturer to obtain FDA approval for the sale of their version of the shaped highly cohesive breast implant, followed by Allergan for their style 410 breast implants. Developed in the early 90’s, and used widely throughout the rest of the world, the Style 410 manufactured by Allergan has become one of the most widely used highly cohesive gels used in the world. The Mentor CPG remains in clinical trials until it is approved by the FDA. Although all of these manufacturers have developed a highly cohesive gel implant, they differ from each other with respect to the consistency of their fill (cohesivity), their shape, and the percentage of gel that they are each filled with.
Although the shaped highly cohesive gels will be new to many US plastic surgeons, they are not new to Dr. Glicksman. Allergan encouraged specialized training in the use of their devices, and Dr. Glicksman underwent extensive training in Sweden before being given the opportunity to enroll patients in clinical trials. She has enrolled hundreds patients since 2005 and has extensive experience with the highly cohesive breast implants. Dr. Glicksman uses shaped highly cohesive gel breast implants for both primary breast augmentation or revision breast augmentation, and breast reconstruction after mastectomy.
Frequently Asked Questions
How are highly cohesive breast implants different from standard round gel implants approved in 2006?
Cohesivity: The more cohesive silicone gel is, the thicker and firmer it becomes. This explains why silicone can come in a liquid form, like in your hair gel, as well as the solid form like your kitchen cutting board. 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. Each of the different manufacturers, Allergan, Mentor, and Sientra, have designed highly cohesive breast implants with different degrees of cohesivity. The increased form stability of these breast implants leads to reduced implant visibility and palpability through the overlying breast tissue and skin.
Shape: The highly cohesive gels offer plastic surgeons and their patients the opportunity to select shaped breast implants. This means that the breast implants have a variable width, height, and projection. The possible advantage to a shaped device is that it offers plastic surgeons more options in selecting an implant that can fit your individual body shape and size, as well as the quality of your breast tissue. Shaped highly cohesive breast implants are especially useful for patients with breast or chest wall asymmetries, or patients with tuberous or constricted base breasts. 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 a more proportionate breast augmentation.
Rupture Rates and Capsular Contracture: The 7 year data collected from the United States, as well as the data collected from Europe and Canada, shows very low rupture rates with the highly cohesive gel implants. More data will continue to be collected over the next 10 years.
Will I need a larger incision if I choose form stable 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 high resolution ultrasound techniques are on the horizon.
Approval of Highly Cohesive Breast Implants-More choices for American Women
Allergan received FDA approval in the United States on February 20, 2013 almost a year following the approval of the Sientra shaped and round highly cohesive gel implants. Dr. Glicksman was an active investigator in the clinical trials that led to the FDA approvals. American women finally have more choices for augmentation, reconstruction and revision procedures. Safety concious women, who are looking for a proportionate breast augmentation, may prefer these breast implants.
Patients interested in highly cohesive breast implants can visit www.drglicksman.com or www.cohesivebreastimplants.com and click on “find a cohesive breast implant surgeon” to locate a highly experienced board certified plastic surgeon in your region of the country.
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 the best breast implant for you. Additional assessment of your breasts can also be performed with the Vectra 3D simulation. This gives women the opportunity to visualize several different breast implant options and creates a better educated patient. Dr. Glicksman has over 8 years of experience with highly cohesive gel implants, making her well qualified to help guide you towards the safest, long lasting breast implants for you.
For more information on the Allergan or Sientra highly cohesive cohesive gel implants:
- Contact office @ 732-974-2424 or email@example.com
- American Society of Plastic Surgeons breast augmentation information
- Read: “The Best Breast Book II” by Dr. John Tebbetts, CosmetXpertise, Dallas, Texas
- The Safety of Silicone