Is the Ideal Breast Implant Really Ideal?
- Asked 4 years ago
i saw a tweet that said the doctors TV show would talk about Ideal Implant, the newest hybrid breast implant on the market. i looked at the Ideal Implant web site and saw they are doing a study with 500 women augmented with the implants. Do any doctors have knowledge about the study and whether women are seeing really good results? Is the implant truly ideal or are their downsides?
FDA approved clinical trial for the Ideal Implant
I am a clinical investigator for the FDA approved Ideal Implant Study. Currently there are 36 investigators located in Florida, Georgia, Texas and California.
The idea behind this implant is create a saline filled implant that has some of the characteristics of a gel filled implant. This implant is very different from the old double lumen implants. There are actually two different and separate saline filled chambers. There is a posterior chamber that is similar to a standard saline filled implant. The anterior chamber has two extra silicone rubber sheets with slits that act as baffles.
These act to reduce the movement of saline as found with a standard saline filled single lumen implant. The idea is to reduce the sloshing of fluid. The implant is made from the same components and materials as standard available implants so its safety is not in question. The trial has been in progress only since April. I have performed two augmentations with this implant, my partner has done 5. Currently approximately 130 have been performed.
The feel and shape of the implant, at this point, seems to be an improvement over the standard saline filled implant and patients have been satisfied. One of my patients was a remove and replace patient who did not like the shape or feel of her current saline filled implant. She feels that, in her situation, the Ideal implant is an improvement.
Patients who desire breast augmentation with saline filled implants but would like more of the feel of a gel would be the likely candidates for the implant. It will take more time, thus the 10 year trial, to see if there are actual benefits to the implant over what is currently available.
Web reference: http://www.idealimplant.com
Call me a skeptic on Ideal Implant
Generally speaking, the more complex the design of an implant the more likely they are to fail/rupture. This has been demonstrated repeatedly over 30 years of dual-chambered or multi-lumen implants. At the price these implants are apparently going to come to market at (more then silicone implants), I have no idea why you'd select this over the latest gummy-bear style devices which have a proven clinical record with lower complication rates observed in FDA clinical trials of the latest Sientra, Mentor, and Allerghan implants
NEW IDEAL IMPLANT PROMISING THUS FAR
Ideal Breast Implant Trials Promising
With the Ideal Implant, women will no longer have to choose between peace of mind and a great result when it comes to breast augmentation. Dr. Larry Nichter explains.
Saline and Silicone, Safety and Performance
Dr. Larry Nichter
Women have so far had essentially just two breast implant fill choices: saline or silicone.
Silicone implants have distinct advantages over saline implants in terms of performance: they wrinkle less and conform to a more natural breast shape, and also have a softer feel that is more breast-like. However, silicone implants have gained a reputation—possibly undeserved—for being less safe than saline implants. Despite the fact that there is no known toxicity of silicone gel breast implants, the possibility of a “silent rupture,” undetectable except by MRI, has been enough to make many women opt for saline implants or wait for a better product to come along. The time will be here most likely within a year or so with the advent of the Ideal Implant, the name given to a new design saline hybrid implant. It has the natural feel of silicone and safety of saline.
Saline implants, though providing peace of mind by being perceived as safer than silicone, often do not create a result that seems as natural. Wrinkling, scalloping, a globular shape, and water balloon-like feel, and increased risk of capsular contracture have been the trade-off for peace of mind with breast implants. The Ideal Implant solves many if not all of these concerns.
The Ideal Implant has both
The Ideal Implant is one of the major technological advances to come along in the past few decades in implant manufacture. Using a novel design with internal baffles, the saline implant is manufactured to achieve a similar feel and performance comparable to a silicone implant. Approximately 95% of both patients and their surgeons expressed satisfaction at the current two-year data point by the FDA. The Ideal Breast Implant is soon to be released in the US market, hopefully with in the year.
As one of the lead FDA study investigators, I have personally followed my Ideal Implant patients for more than two years. The vast majority of my patients are thrilled with the results. My follow up exams indicate that in most cases they have the feel more like silicone than saline.
When placed on a convex surface similar to the curve of the chest wall, the Ideal Implant conforms to a more natural breast shape; its edge lies lower and its outward surface does not collapse. This is because engineers designed the Ideal Implant with three nested baffle shells, which are unattached and perforated. This makes the saline move slowly between the compartments, giving it gel-like characteristics and a feel more like that of a natural breast.
The Ideal breast implant uses no new materials or manufacturing processes—only tried and tested ones—and is made completely in the United States. The manufacturing process is automated to ensure uniform thickness of the membrane shell, unlike the hand-dipped ones that are used for breast implant manufacturers by other companies. Perhaps most important, the President of the Company, Dr. Robert Hamas, indicated that this implant will only be made available to board certified plastic surgeons by the American Board of Plastic Surgery. To date, the other saline breast implant companies in the US, Allergan and Mentor, sell their product essentially to any MD or DO whether they are a plastic surgeon or not, and even to non-surgeons without board certification. This gives an added advantage to the consumer knowing that when they have an Ideal breast implant placed it will be done by someone well trained and competent—by a board certified plastic surgeon.
The Ideal breast implant is currently undergoing FDA trial studies in 502 women, the second-year results were recently released and are very promising. The capsular contracture rate, for example, at the two-year follow up mark of the current FDA study indicates a dramatic decrease of capsular contracture. To date, the Ideal breast implants show significantly lower rates of capsule contracture and wrinkling, as well as high patient satisfaction. Deflations from early manufacturing defects were identified and addressed, and manufacturing processes have been refined.
Though it has yet to be released to the general public, the Ideal Implant is shaping up to be a contender in the open market with traditional saline and silicone implants.
To receive updates about the ideal implant or to be placed on Dr. Nichter’s waiting list for the procedure, please contact our office - see below link
Web reference: http://drnichter.com/ideal-breast-implant/
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The ideal breast implant
I "felt" the "ideal breast implant" for the first time at the ASAPS meeting in Boston 2011. I was quite impressed by the overall softness of the implant and resistance to rippling. I am excited to see how this new option behaves under the breast, assuming it gets FDA approval.
The market for this implant will likely be patients who want a lot of the advantages of silicone implants with the safety of a saline implant.
What a great name! This is a company that is making a variation of the saline implant but it is still experimental and no studies are available to review.
Ideal implant is still under clinical investigation
The ideal implant is a proprietary name for a breast implant that is still under clinical investigation. The final results of the clinical investigation is still not published. Patients can sign up to be in the clinical trial but most plastic surgeons would prefer to implant a breast implant that has stood the test of time for safety since there may be longterm risks with any breast implant.
Information about Ideal breast implant
Ideal Implant is not a description, but rather is the name of the company that produces a new hybrid saline breast implant that is undergoing an FDA trail. I am one of the few investigators across the country, and am also the surgeon who presented this implant on "The Doctors" television show. I have had great success with this implant.
The new "ideal implant": advantages and disadvantages. Is it the "perfect" implant?
You most likely read a press release from the company or from another interested party that touts the advantages of the implant without a critical analysis of the product.
In my experience the "supposed advantages" also work out to be disadvantages. For example, for a brief time, we had implants that were combination saline and silicone; composed of an inner and outer balloon type structure. Some had silicone in the outer chamber while others had saline in the outer chamber. These werer claimed to have the advantages of both implants. But they also had the disadvantages of both (higher saline rupture rates plus the "mess" of a silicone rupture) in addition to difficulty in interpreting the mammogram or MRI signs of rupture.
My guess is that the ideal implant may have a slighlty better shape then the standard saline but I would predict potentially higher rupture rates of the individual chambers necessitating removal of the entire implant. In any case, we don't know at this time and we will have to "wait and see".
Ideal breast implant?
The "ideal breast implant" is a saline filled implant with different types of chambers than the "traditional" saline implant. I have never used this implant and have no knowledge of it. Once I see the results of the studies, I can make some assessments.
What's in a name? Ideal Implant may or may not be
Simply put, different implants will be "ideal" for different women. For example, the "gummy bear" implants generated a lot of excitement when they were in early stage trials, but now the doctors who participated in the trials estimate that they will be the best choice for only 15-20% of augmentation patients. As Dr. Stratis pointed out, the "Ideal Implant" is in clinical trials now and it will be years before we know whether it really has advantages. Fortunately there are very good options available now.
These answers are for educational purposes and should not be relied upon as a substitute for medical advice you may receive from your physician. If you have a medical emergency, please call 911. These answers do not constitute or initiate a patient/doctor relationship.