Cohesive breast implants (aka gummy bear breast implants) Natrelle 410 – Mentor CPG – have been used worldwide for nearly 15 years and have undergone over 6 years of rigorous testing in the United States. Despite international patient enthusiasm for gummy bear breast implants, the opinions of many European plastic surgeons is that cohesive implants are the best breast
Implants in the world, and in spite of the most favorable data on any breast implant, cohesive breast implants are not yet widely available in the United States. For now, they are only available to limited numbers of patients fortunate to find doctors participating in the clinical trials of cohesive gel breast implants.
Q: Why Gummy Bear Breast Implants are a Sweeter Alternative to Saline Breast Implants?
Saline filled breast implants and other liquid-filled implants have enjoyed a long reign as the solitary choice for women who wanted to enhance their breast size. But now, high-strength silicone gel implants, commonly known as “gummy bear” implants are proving to be a much more acceptable option.
Q. What are “gummy bear” breast implants?
Gummy bear breast implants are implants that are made of a high-strength silicone gel. The material is very dense, resulting in a semi-solid form. High-strength gel implants have been nicknamed “gummy bears” because, when cut, they adhere just as gummy bear candy would.
Q. What are the benefits of high-strength silicone gel implants?
High-strength gel implants differ significantly from liquid-filled saline and silicone implants, and they offer unique advantages. Because they are semi-solid, they maintain their shape and remain in an upright position. Unlike liquid-filled implants, they are not likely to wrinkle, fold or ripple. And liquid-filled implants, when overfilled, can be hard. Gummy bear breast implants feel soft and natural.
Q. Will they look and feel natural?
High-strength gel implants are the next dimension in breast implants. Designed to replicate the look and feel of a natural breast, they are soft to the touch and maintain their shape for a natural, upright appearance.
Q. Are they comfortable?
Many of the study participants who had previous breast implants say that, in terms of comfort, they can’t feel the high-strength gel implants underneath the skin, but that they could always feel saline implants. In addition, there is no sloshing sound, which can occur with liquid implants.
Q. Are they safe?
I believe high-strength gel implants will prove to be very safe. Silimed, the manufacturer of the breast implants, holds an ISO 9001certificate for meeting strict industry standards in the manufacturing process, as well as a perfect FDA rating under the FDA Custom Good Manufacturing Process (CGMP).
Q. Where are they available?
Silimed’s high-strength silicone gel implants have been popular in Europe since 1995 and in Canada since 2000. But the FDA has only approved testing them in the U.S. in 2002. Currently, the Silimed brand of high-strength gel implant is being studied for mass use in breast augmentation, breast lift and breast reconstruction surgery.
Q. What is the purpose of the study?
The goal of this study is to ensure that the FDA, along with breast implant manufacturers can provide substantiated data on the safety and effectiveness of the devices. Specifically, they are examining rupture rates, as well as the causes and effects of the ruptures. High-strength gel implants, though much less likely to rupture, are also being studied, but mainly because of the overall safety concerns that have arisen from the use of liquid-filled implants.
Q. How does the study work?
During the study period, a total of 1,000 patients will be selected to participate in the research. All participants must consent to periodic follow-up examinations and to completing routine paperwork. For their participation, patients will be paid $50 per follow-up visit, up to $650 over a ten-year period.
Q. Am I eligible to participate in the study?
You may be eligible to participate in the study if you are a woman, in good health, who meets the following conditions:
You are at least 18 years old and this is your first breast augmentation surgery or a revision of a prior breast augmentation.
You are any age and this is your first breast reconstruction surgery.
It is important to remember, however, that only surgeons who are participating in the FDA study may perform the surgery.
Q. If I have breast implants, but I’m unhappy with the results, can I participate in the study?
You may participate in the study if you are in good health, are at least 18 and you have had a previous breast augmentation with which you are not satisfied.
Q. Will I be able to get the size I want?
There are 9 models of Silimed’s high-strength gel implants and they are available in a variety of sizes. In fact, at my practice, we recently began testing a super-large size that allows us to achieve cup sizes of “D” to “DDD.” This implant size, from 600 to 1,000 cc, was not available when the study was begun. Prior to the procedure, your surgeon will help you determine the appropriate model to achieve the look you desire.
Q. How will I be prepared for the procedure?
Prior to your acceptance to the study, you will be required to undergo and pass a physical exam, diagnostic tests, health screenings and mammograms. You may be referred to other physicians to complete some of these tests. In addition, you will be asked to take photographs and complete medical and other forms related to the procedure. Your surgeon will also meet with you to discuss any precautions, questions you may have about the implants, your desired results and surgery aftercare.