Cohesive Gel Implants - What Are They?
http://article.nanolive.com/articles/120615/1/Cohesive-Gel-Implants---What-Are-They/Page1.html
Abigail Aaronson
Many women are unhappy with the size or contour of their breasts and are choosing breast implants. The decisions to be made before surgery are often more difficult than the surgery itself. Visit http://www.envisionimplants.com to see our Envision Breast Implant Sizing System. Our system contains the tools to help you make your choice. By Abigail Aaronson
Published on 07/17/2008
Cohesive gel implants have the nickname of "gummy bear implants". This will explain a bit about their invention and their status in the market.
Currently the only choices in breast implants are silicone and saline, both of which are made of an outer shell (sac) that is made of a silicone rubber material. The silicone and saline refer to the filling of the implant itself.
Silicone implants made their appearance in the early 1960's and continue to evolve according to what women were asking for (softer more life like) until 1992 when the FDA began investigations into health risks associated with it. After long term research and data, the FDA and medical community failed to show any link between silicone and long term health issues. In 2006, the FDA approved its use once again for the general public.
Saline Implants came onto the scene shortly after silicone in the 1960's and was the only one that remained available during the FDA investigations into silicone. They are filled with a sterile saline solution (salt water) that is a liquid.
The cohesive gel implants are different from the others because it's filling is a semi-solid. If one of these is cut in half, the filling stays intact and resembles that of a gummy candy (be it a bear, a worm or a dinosaur), hence the nickname Gummy Bear Implants.
It was invented in the 1990's and has been used in Europe for the last three years and in Brazil for 10 years. Since the FDA considers breast implant as a "medical device" there are stringent requirements for the manufacture, testing and reporting of the clinical trial results. The FDA will consider the usage outside the US in their decision; a large scale study (clinical trials) must be done first.
The three companies approved to conduct clinical trials are Allergan, Mentor and Silimed. Some of the implants are approved only for breast reconstruction; some for breast augmentation. Long term follow-up (10 years) is a critical factor and some of the doctors approved, are requiring women who enroll in the study be available for these follow ups.
At this time the gel implants appear to be meeting the goals set for safety and if you are considering participating in a study, then you need to be prepared for the extensive follow-up requirements. Some women are very comfortable with being on the cutting edge of technology, while some have a more "wait and see" feeling. There is no right or wrong way to go; every woman must decide for herself which way is best for her.
Cohesive gel implants are preferred by many women because they are the firmest due to their semi-solid make up. Silicone are the next firmest followed by saline, the softest. If you are looking for a firm breast, you may want to look for doctors near you who are performing clinical trials on the new cohesive gel implants.
As far as value is concerned, silicone implants cost about $1,000 more than saline but gummy implants cost only a few hundred more than silicone, and if you are part of a study, it is possible you will be reimbursed for the cost over a ten year period. A breast augmentation is a long term investment and commitment you make to yourself.
Not all doctors are part of the clinical trials and not every woman who applies is accepted. When you do research on looking for your surgeon, first make sure that he is board certified by the American Society of Plastic Surgeons (ASPS). Once you find your surgeon, ask if they are participating in any of the clinical trials currently underway for the cohesive gel implants.
There will be much paperwork should you be accepted into a clinical trial. Make sure you understand everything you are signing and agreeing to, before considering surgery. When you are done reading and researching, you have taken some very big steps in the journey to the new you!
Silicone implants made their appearance in the early 1960's and continue to evolve according to what women were asking for (softer more life like) until 1992 when the FDA began investigations into health risks associated with it. After long term research and data, the FDA and medical community failed to show any link between silicone and long term health issues. In 2006, the FDA approved its use once again for the general public.
Saline Implants came onto the scene shortly after silicone in the 1960's and was the only one that remained available during the FDA investigations into silicone. They are filled with a sterile saline solution (salt water) that is a liquid.
The cohesive gel implants are different from the others because it's filling is a semi-solid. If one of these is cut in half, the filling stays intact and resembles that of a gummy candy (be it a bear, a worm or a dinosaur), hence the nickname Gummy Bear Implants.
It was invented in the 1990's and has been used in Europe for the last three years and in Brazil for 10 years. Since the FDA considers breast implant as a "medical device" there are stringent requirements for the manufacture, testing and reporting of the clinical trial results. The FDA will consider the usage outside the US in their decision; a large scale study (clinical trials) must be done first.
The three companies approved to conduct clinical trials are Allergan, Mentor and Silimed. Some of the implants are approved only for breast reconstruction; some for breast augmentation. Long term follow-up (10 years) is a critical factor and some of the doctors approved, are requiring women who enroll in the study be available for these follow ups.
At this time the gel implants appear to be meeting the goals set for safety and if you are considering participating in a study, then you need to be prepared for the extensive follow-up requirements. Some women are very comfortable with being on the cutting edge of technology, while some have a more "wait and see" feeling. There is no right or wrong way to go; every woman must decide for herself which way is best for her.
Cohesive gel implants are preferred by many women because they are the firmest due to their semi-solid make up. Silicone are the next firmest followed by saline, the softest. If you are looking for a firm breast, you may want to look for doctors near you who are performing clinical trials on the new cohesive gel implants.
As far as value is concerned, silicone implants cost about $1,000 more than saline but gummy implants cost only a few hundred more than silicone, and if you are part of a study, it is possible you will be reimbursed for the cost over a ten year period. A breast augmentation is a long term investment and commitment you make to yourself.
Not all doctors are part of the clinical trials and not every woman who applies is accepted. When you do research on looking for your surgeon, first make sure that he is board certified by the American Society of Plastic Surgeons (ASPS). Once you find your surgeon, ask if they are participating in any of the clinical trials currently underway for the cohesive gel implants.
There will be much paperwork should you be accepted into a clinical trial. Make sure you understand everything you are signing and agreeing to, before considering surgery. When you are done reading and researching, you have taken some very big steps in the journey to the new you!