Is anyone familiar with this brand of implant or have experience using it? Is this available in the US? Cost of these compared to other brands? Manufacture and specifications of this comparble to others, specifically 16-18 layers, additional membrane to guard against leaching?
Answer: Non-FDA approved Breast Implants
Buyer beware! The FDA, although occasionally criticized, makes recommendations to physicians on the practice of medicine, but does not mandate how we can practice medicine (FDA approves Botox for Glabellar wrinkles, but physicians can treat patient's crow's feet and forehead in an off-label fashion).
However, the FDA scrutinizes medical devices used by physicians in the US for SAFETY...and they do a very good job of researching and critically evaluating devices. If these implants are not FDA approved (yet....they are manufacturer and sold by a French company I believe), then Board Certified Plastic Surgeons, and any licensed MD for that matter, cannot use them.
If a physician has offered to use an non-FDA approved device in your body....Run away fast!
Instead, meet with a Board Certified Plastic Surgeon and he/she will be able to answer all your questions and provide a SAFE plan for you.
Hope this helps!
Dr. C
johnconnorsmd.com
Helpful 2 people found this helpful
Answer: Non-FDA approved Breast Implants
Buyer beware! The FDA, although occasionally criticized, makes recommendations to physicians on the practice of medicine, but does not mandate how we can practice medicine (FDA approves Botox for Glabellar wrinkles, but physicians can treat patient's crow's feet and forehead in an off-label fashion).
However, the FDA scrutinizes medical devices used by physicians in the US for SAFETY...and they do a very good job of researching and critically evaluating devices. If these implants are not FDA approved (yet....they are manufacturer and sold by a French company I believe), then Board Certified Plastic Surgeons, and any licensed MD for that matter, cannot use them.
If a physician has offered to use an non-FDA approved device in your body....Run away fast!
Instead, meet with a Board Certified Plastic Surgeon and he/she will be able to answer all your questions and provide a SAFE plan for you.
Hope this helps!
Dr. C
johnconnorsmd.com
Helpful 2 people found this helpful
September 1, 2015
Answer: These implants are not available here
These implants are not approved for use here. Beware newer implants to the market. Case in point: PIP implants.
Helpful
September 1, 2015
Answer: These implants are not available here
These implants are not approved for use here. Beware newer implants to the market. Case in point: PIP implants.
Helpful
November 14, 2014
Answer: Cereform Breast Implants
There are only two companies allowed to sell implants here in the US and even they can not sell all of the implants they make here. The FDA sets a very rigorous process in place to monitor safety and citizen protection from medical devices. The implants you are asking about are from a French Company that are not available here in the US. I would recommend you be careful about getting something that is not FDA approved. Many times we in the US complain about having to wait for FDA approval of some new product that is available in Europe only to find a bit later that the product had a lot of problems that no one was aware of when it was released.
Helpful
November 14, 2014
Answer: Cereform Breast Implants
There are only two companies allowed to sell implants here in the US and even they can not sell all of the implants they make here. The FDA sets a very rigorous process in place to monitor safety and citizen protection from medical devices. The implants you are asking about are from a French Company that are not available here in the US. I would recommend you be careful about getting something that is not FDA approved. Many times we in the US complain about having to wait for FDA approval of some new product that is available in Europe only to find a bit later that the product had a lot of problems that no one was aware of when it was released.
Helpful
January 7, 2011
Answer: Off-label or unapproved breast implants
Why would you get implants that are not approved in this country?
The risk of using an illegal or grey-market product vs. some theoretical unproven advantage just does not make sense.
Stick with a board certified plastic surgeon with considerable experience and great credentials.
Helpful 1 person found this helpful
January 7, 2011
Answer: Off-label or unapproved breast implants
Why would you get implants that are not approved in this country?
The risk of using an illegal or grey-market product vs. some theoretical unproven advantage just does not make sense.
Stick with a board certified plastic surgeon with considerable experience and great credentials.
Helpful 1 person found this helpful
Answer: Cereform breast implants
Cereform implants are produced by a company located in the North of France. They are not however FDA approved for use here in the U.S. so you need to be very careful should you choose to go that route. If you are U.S. based and a surgeon is offering to use these you should seek another surgeon immediately.
If you are based in Europe, again I caution you to be very careful. The FDA puts medical devices through rigorous testing for safety and if they haven’t been approved yet you are risking your health unnecessarily. Currently only Allergan and Mentor produce implants that have FDA approval and I strongly recommend that only implants that have passed the FDA’s testing should be placed within your body. Consult with a board certified plastic surgeon and remember that safety should always be your biggest priority.
Helpful
Answer: Cereform breast implants
Cereform implants are produced by a company located in the North of France. They are not however FDA approved for use here in the U.S. so you need to be very careful should you choose to go that route. If you are U.S. based and a surgeon is offering to use these you should seek another surgeon immediately.
If you are based in Europe, again I caution you to be very careful. The FDA puts medical devices through rigorous testing for safety and if they haven’t been approved yet you are risking your health unnecessarily. Currently only Allergan and Mentor produce implants that have FDA approval and I strongly recommend that only implants that have passed the FDA’s testing should be placed within your body. Consult with a board certified plastic surgeon and remember that safety should always be your biggest priority.
Helpful