Any update on a possible availability of silicone implants over 800 cc?
Any ideas why they are not available yet? Is it because of safety concerns?
They are available; however, they must be made custom. A breast implant of 800 cc's weighs nearly two pounds! Additionally, you are asking your skin to support that weight. With that weight, the breasts can bottom out, stretch and all sorts of unnatural things can happen. You can lose sensation in your nipples because the nerves become stretched. In my opinion, it is extremely rare that I will place an implant over 600 cc's. While they will look great for several years, they look terrible as you age. Good luck, and I hope this answers your question.
Published on Jul 11, 2012
There is a hotline number on the website of Mentor and Allergan, and you can also look at the website to get the answer directly from the company. That said, they currently DO NOT MAKE implants over 800cc.
Published on Jul 11, 2012
I never discussed this with the impalnt makers, but maybe due to demand. Generally speaking, there is not a big demand for implants that size.
Published on Jul 11, 2012
It is because the manufacturers are unwilling to go through the entire FDA process of getting silicone implants over 800cc approved in the US. I am fortunate that I have an exclusivity to obtain custom sizes of over 800 cc's (silicone) for my patients.
Published on Jul 11, 2012
Silicone implants larger than 800 cc are not yet available. They are being studied and are under FDA trials by Mentor. We hope to see them commercially available in 1-2 years.
Published on Jul 11, 2012
Thank you for your question. Mentor makes a moderate plus and high-profile silicone implant that has an 800 cc volume. It is possible to exceed this volume with a tissue expander or saline implant that is overfilled. However, I would not recommend exceeding this large volume because of the potential negative side effects to the breast skin and tissue. We have learned that excessively large breast implants can result in thinning of the skin, increased breast pain, more visible rippling, neck and back pain.
Published on Jul 11, 2012
There are a few reasons they are not available:
-The FDA will not approve them without tests of implants that size. As implants get that big and heavy, they put more stress on the shell and the FDA has required a separate clinical trial if the manufacturers want to sell implants that big.
-There is so little demand for implants that large that they are unlikely to be tested and made available.
-Finally, many of the people who want implants that big are women looking for "novelty" breasts (e.g. niche models, erotic performers, and those looking for a gimmick). No matter how tall a woman is, even 800cc implants look very large. And even if a woman wants breasts that large, the weight of an implant that heavy will invariably stretch the skin, thin the tissue, and go south. No breast of that size, whether natural or augmented, looks good over the long haul.
My practice focuses on creating beautiful, balanced, and elegantly shaped breasts. But I want to emphasize that even those who like the look of gigantic breasts need to be certain that they are willing to permanently damage their tissues.
Published on Jul 11, 2012
Best option: Go online & interact w/ Allergan & Mentor manufacturing corporations for information.
Published on Jul 11, 2012
The reason that we don't have implants over 800 mL in silicone is that they have to be FDA approved. It takes millions of dollars to get approvals from the FDA in doing the studies that they would need to do. They are working on The possibility of having larger implants that are for women doing breast reconstruction that are larger individuals is being talked about. Nobody has any idea how long this will take. And yes there are more complications with larger implants has the larger the implant the thinner the tissue is around the implant.
Published on Jul 11, 2012
I have spoken to an insider to one of the US manufacturers, and he told me that they are looking for FDA approval for many of their available implants in sizes greater than 800 cc. The way I like to look at it is that larger implants require more maintenance. If you are willing to have surgery at twice or three times the rate of your typical breast augmentation patient, then these larger devices are for you.
Published on Jul 11, 2012
Breast implant sizers are limited to 800 cc's for cosmetic purposes. In general, each 200 cc's yields about one bra cup size larger (less for large patients, more for small patients). So 800 cc's generally yields an increase of approximately four bra cup sizes. As the implant gets larger and larger, the complication rates increase such as irreversible stretching of the breast, malposition of the implant, nipple numbness, and ptosis (droopiness) of the breast because of the chronic weight of the implant. So, Beyond 800 cc's, the risk to the patient is too high because of the high likelihood of complications. And beyond 800 cc's, the liability to the physician and to the manufacturer is too high, even if the patient relieves them from liability... because to a jury, the physician "should have known better". I have been in practice over 20 years and I have never encountered a patient who wasn't well endowed and extremely pleased when I implanted 800 cc implants.
Published on Jul 11, 2012
Thank you for asking. These products will be available soon pending final FDA clearance. They are expected to have the same high safety profile as currently used implants. Each patient's candidacy still needs evaluation by a board certified plastic surgeon and many patients will benefit from the new available volumes. Hope this helps.
Published on Jul 11, 2012
Thank you for your question... this is a common question and I don't know the answer what the reason is for not having larger than 800cc silicone gel implants.
Sorry that I cannot answer with more information.
Published on Jul 11, 2012
I am unaware of any updates on silicone implants greater than 800 cc. I do not do 800 cc implants very often so I am not in discussion with the implant manufacturers regarding this issue. Perhaps some of the time that it is taking to get them into the manufacturing process is a business issue of how many patients would want them. Hope this helps.
Published on Jul 11, 2012
Implants larger than 800 cc tend to have more complications and lead to over augmented patients frequently. The manufactureres are creating studies using implants greater than 800cc's for reconstructions on larger patients. They may be available in the market some day again.
Published on Jul 11, 2012
The FDA is a turtle not a hare. The Mentor clinical trials for silicone implants up to 1400cc have not yet been approved in their finalized form. This was anticipated over the summer but just has not happened. There is a lot of back and forth between Mentor and the FDA with the FDA wanting this, and then that, and then no not really we want this, and no not really we meant that...............and on and on.
It will happen, it is only a matter of when. The initial trials, called the Athena trials, will enroll breast cancer reconstruction patients only. At some point in the future they may expand this trial to include aesthetic breast augmentation patients, or they may not. My instinct tells me that they will not, but you never know.
Then once final approval is given we will be able to obtain them and use them!
As slow as they are, ultimately their goal is your protection. This is the same FDA that did not approve PIP implants from France, which turned out to be a wise decision. These implants were use in 65 countries on more than 300,000 patients, and it turns out they were filled with industrial grade silicone not medical grade silicone, making them unsafe and prone to degradation. We are still in the process of replacing these on international patients, and the former CEO of that company is in prison in France.
Published on Jul 11, 2012