The attempt to increase breast size and improve shape using various materials such as ivory, glass, rubber, animal cartilage and sponges dates back to the late 19th century. We’ve come a long way since those days. Todays options for breast enlargement include both saline and silicone implants. Breast augmentation is one of the Top 5 cosmetic surgeries performed in the U.S.

There are multiple decisions to make when considering breast implants, including size, feel and shape, incisions, downtime and recovery, cost, the affect on your social and family relationships. Now there is another thing to consider. Form-stable highly cohesive gel implants, also known as Gummy Bear Breast Implants are available from three breast implant manufacturers in the U.S., Sientra, Allergan, and Mentor. These implants are called Gummy Bear implants because their maintain a stable form. This means that the material that is used inside these new implants retains its shape, just like the real Gummy Bear gelatin candies. Unlike the liquid silicone implants used many years ago that would ooze out of a ruptured implant shell, the current generation of implants can maintain its shape even if cut with a knife.

What is the significance of a form stable implant?

  • These implants hold their shape if ruptured.
  • Gel leakage is minimized because of the integrity of the shape
  • Unlike saline implants they pass the “hug test” because there is less resistance with pressure resulting in a softer breast

FDA Approves Gummy Bears

In March 2012, the FDA approved the “Gummy Bear” implants produced by Sientra. So far, Sientra is the only implant company that has made a pledge to provide implants exclusively to board-certified plastic surgeons, increasing the patient safety and efficacy.

History and Safety of Silicone-Gel Breast Implants

In 1992, the FDA removed silicone implants from the market because of claims that this type of implant was linked to cancer, autoimmune, and connective tissue disorders. Subsequent studies have proven that silicone breast implants do not cause breast cancer or connective tissue disease. Research has shown that these diseases were no more common in women with silicone implants than in women without them.

Breast feeding

Breast implants do not impair the ability to breast feed. In addition, there is no risk in nursing your infant after undergoing breast augmentation using silicone implants.


Concerns about implants and mammograms arose in the 1960s and 1970s when both mammograms and silicone breast implants were in their infancy. Since then, both mammogram and implant technologies have improved. Mammography now achieves more sophisticated imaging, and in 1988, a more advanced technique was introduced for manipulating the implant without compressing it.

FDA Approval

THe FDA ban against silicone breast implants was lifted in 2006. The approval to bring silicone implants back was contingent upon continued monitoring of women who had undergone breast augmentation prior to the approval for a period of 10 years. This represents an active commitment to ensure the safety of silicone implants for use in women.

Age Restrictions

There are age restrictions for both saline and silicone breast implants used for cosmetic breast augmentations. Women under the age of 18 are restricted from using any type of implant for cosmetic augmentation. Silicone implants are restricted to women older than 22. However, both types of implants may be used for reconstructive purposes. The age restrictions are based on the fact that breast tissue may still develop and change for several years after puberty, so there is concern that augmentation will be performed before full growth has occurred. The restricted use of silicone implants in women 22 years and older may have to do with the FDA’s concern about long term follow up.

What to Expect From Silicone-Gel Breast Implants

As with all surgeries, there may be risks or complications. Most women outlive their implants. However, implants are a man made device that may not last for your entire life time. Over your lifetime, gravity, and age, pregnancy or nursing related skin changes may prompt the desire to replace your implants and lift your breasts. In addition, surgery may be required because of implant rupture or deflation, capsular contraction, infections, implant position displacement, etc. The FDA also recommends a periodic MRI scan to screen for the possibility of silicone implant ruptures or leaks.

More About What Makes cohesive Silicone Different

Cohesive gel breast implants seem to hold their shape for a much longer time than standard silicone implants. Gummy Bears or cohesive gel silicone consist of the same material as standard (silicone) gel, but have more cross-linked molecules which bond together better, creating a more stable shape or form. The gel has a thick consistency that does not slosh within the shell of the implant. The folds and rippling that are more likely with saline and silicone implants are less likely to occur with this form stable implant. And, even if a rupture occurs, the silicone gel will not leak or drip out.

Three anatomic implant companies in the U.S.

Until the beginning of 2012, the only available FDA-approved silicone-gel breast implants have been round. With the approval of Sientra‘s form-stable highly cohesive silicone gel implant in 2012, and Mentor and Allergan‘s similar implants in 2013, you now have a choice of a shaped implant. A shaped implant may be recommended, if you prefer a more natural appearing breast. Sientra’s form-stable implants also come in different sizes and shapes (round or anatomic), and have either smooth or textured shells. Currently, Mentor and Allergan form-stable implants are only available in textured, anatomic form.

Do Your Homework for best results

The FDA, ASAPS, and ASPS are confident that breast implants are safe and effective, but a procedure is only as good as the hands that perform it, so follow these rules:
Make sure your surgeon is certified by the American Board of Plastic Surgery
Make sure your surgeon has had adequate experience with the exact procedure you are undergoing
Even if your surgery does not occur in a hospital, make sure your surgeon has operating privileges to perform the surgery you’re undergoing in an accredited hospital
Make sure that the facility in which you undergo your procedure is accredited

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