Harold J. Brandon, Larry S. Nichter, Dwight D. Back
Abstract: The IDEAL IMPLANT® structured breast implant is a dual lumen saline-filled implant with capsular contracture and deflation/rupture rates much lower than single-lumen silicone gel-filled implants. To better understand the implant’s mechanical properties and to provide a potential explanation for these eight-year clinical results, a novel approach to compressive load testing was employed. Multi-dimensional strains and tangent moduli, metrics describing the shape stability of the total implant, were derived from the experimental load and platen spacing data. The IDEAL IMPLANT® was found to have projection, diametric, and areal strain that were generally less than silicone gel implants, and tangent moduli that were generally greater than silicone gel implants. Despite having a relatively inviscid saline fill, the IDEAL IMPLANT® was found to be more shape stable compared to gel implants, which implies potentially less interaction with the capsule wall when the implant is subjected to compressive loads. Under compressive loads, the shape stability of a higher cross-link density, cohesive gel implant was unexpectedly found to be similar to or the same as a gel implant. In localized diametric compression testing, the IDEAL IMPLANT® was found to have a palpability similar to a gel implant, but softer than a cohesive gel implant.
The IDEAL Structured Breast IMPLANT® is essentially a structured double-lumen saline implant similar to a balloon within a balloon, complete with an inner and outer shell that not only supports the shape but also gives the implant a more natural feel. Depending on the size of the implants, in the outer lumens are one to three baffle shells, which float within the saline of the outer lumen to make the saline feel more viscous similar to silicone. The internal structure of IDEAL Structured Breast IMPLANT also controls the sloshing movement of the saline solution, making it feel less like water and behave more like natural breasts would.
Am I A Candidate for IDEAL Structured Breast IMPLANT®
An IDEAL Structured Breast IMPLANT® candidate is someone who likes the natural feel of silicone implants but also wants the benefits and peace of mind of a saline implant. The candidate should be over the age of 18 but not currently pregnant, breastfeeding, or with an active infection anywhere within the body. Patients with existing cancer or pre-cancer who have not received adequate treatment, as well as patients with bleeding disorders or poor overall health, may not be good candidates for the implants. Candidates for breast implants have a choice of 3 main incision sites which are underneath the fold of the breast, through the areola, or the armpit. The insertion site for the IDEAL Structured Breast IMPLANT® can be made in any of these places.
Recovery and Downtime of the IDEAL Structured Breast IMPLANT®
The recovery after having an IDEAL Structured Breast IMPLANT® breast augmentation is comparable to traditional breast implant surgeries. The patient will be sore but is expected to be ambulatory and maintain some arm movement throughout the day to help reduce complications. There will also be a potential for bruising and some swelling after the implant procedure. The downtime really depends on the work and other related activities of the patient. A patient who has a physically demanding job may need four to six weeks off after the procedure but a patient who sits at a desk might only need less than a week off from work. Patients should not do any heavy lifting or physical exercise until they are cleared to do so by their doctor.
Results of IDEAL Structured Breast IMPLANT®
The IDEAL Structured Breast IMPLANT® has a 5.7% five year capsular contracture rate which is lower than traditional saline or silicone implants. A 5-year clinical test was conducted to determine the effectiveness of IDEAL Structured Breast IMPLANT. The test results showed that Ideal had a lower rate of infection, deflation and wrinkling compared to traditional saline or silicone implants. In general, a woman with breast implants will likely have an improved look over a person without breast implants. When breast tissue is stretched or sagging due to aging or pregnancy, the breast loses some volume on top. An implant maintains the volume on top which can be a plus for a woman after pregnancy.
Limitations and Risks of IDEAL Structured Breast IMPLANT®
Because traditional saline implants have only one lumen, it can be rolled up like a cigar and then placed through a tunnel starting from an incision in the belly button and filled with saline once inside the breast. The IDEAL Structured Breast IMPLANT® procedure is limited in that respect because it has two lumens and small baffle shells. However; The incision is slightly smaller and hence less scarring than the silicone gel implant since it can be filled inside of the body rather than outside like silicone implants. As the IDEAL Structured Breast IMPLANT® has only been recently released for general use by the FDA, they are limited in some of the very small and very large size selections for the moment, but the most common sizes are readily available. The manufacturer is currently working on producing a wider array of implant sizes once the demand is sufficient.
The IDEAL Structured Breast IMPLANT is subject to the same risks as standard saline implants. The implant could rupture but since it is saline, the body will safely absorb it just like drinking a glass of water. If a silicone implant ruptures, the patient usually cannot see or feel a difference. With the IDEAL Structured Breast IMPLANT®, there are no expensive tests to check for leaks since a patient can see the deflation immediately in a mirror. With any ruptured implant, the patient will need a follow-up procedure in order to replace the damaged implant. There is a warranty against rupture by the manufacturer that covers this problem.
Although the rate of capsular contracture is lower with this type of implant, it is still a risk. The scar tissue can build up and press against the implant causing it to become firm, too high, and even cause discomfort while the capsule pushes the implant upwards on the chest wall.
Available to Trained Professionals Only
At a safeguard to patients, the IDEAL Structured Breast IMPLANT® is only sold to board-certified or board-eligible plastic surgeons certified by the American Board of Plastic Surgery. A patient looking to have this procedure done can be assured that their surgeon has been properly trained to perform the procedure. Limiting the distribution of IDEAL Structured Breast IMPLANT® to knowledgeable and well trained surgeons is an effort to minimize the risk of botched implants and complications.
The IDEAL Structured Breast IMPLANT® is subject to the same risks as standard saline implants. The implant could rupture but since it is saline, the body can safely absorb it just like drinking a glass of water. If a silicone implant ruptures, the patient usually cannot see or feel a difference. With the IDEAL Structured Breast IMPLANT®, there are no expensive tests to check for leaks since a patient can see the deflation immediately in a mirror. With any ruptured implant, the patient will need a follow-up procedure in order to replace the damaged implant. There is a warranty against rupture by the manufacturer that covers this problem.
Although the rate of capsular contracture is lower with this type of implant, it is still a risk. The scar tissue can build up and press against the implant causing discomfort while pushing the implant upwards on the chest wall.
Available to Trained Professionals Only
At a safeguard to patients, the IDEAL Structured Breast IMPLANT® is only sold to board-certified or board-eligible plastic surgeons. A patient looking to have this procedure done can be assured that their surgeon has been properly trained to perform the procedure. Limiting the distribution of IDEAL Structured Breast IMPLANT® to knowledgeable surgeons is an effort to minimize the risk of botched implants and complications.
Written by Cosmetic Town Editorial Team – SP
Based on an exclusive interview with Larry Nichter, MD in Newport Beach, CA
Natural feel is not the only thing women care about. The FDA approved intact silicone gel implants as safe. However, if a gel implant ruptures the implant and any gel should be removed including the surrounding capsule (capsulectomy). IDEAL® IMPLANT offers women natural feel without the risk of silent rupture. Women value the advantages of IDEAL® IMPLANT over silicone gel:
“Two-Year Outcomes With a Novel, Double-Lumen, Saline-Filled Breast Implant”
Originally published by the American Society for Aesthetic Plastic Surgery, Inc.
Background: A double-lumen, saline-filled breast implant with a baffle structure (IDEAL IMPLANT Saline-Filled Breast Implant; Ideal Implant Incorporated, Irving, Texas) was developed to overcome the limitations of single-lumen saline implants by controlling saline movement and providing internal support to the implant edge and upper pole.
Objective: The authors report 2-year data from a 10-year US clinical trial evaluating the safety and effectiveness of this investigational implant.
Methods: Women seeking primary breast augmentation or replacement of existing augmentation implants were enrolled between February 2009 and February 2010 at 35 private practice sites, where the women underwent surgery to receive the new technology implant. Data collection included incidence and grade of capsular contracture (CC) and wrinkling as well as patient- and surgeon-reported satisfaction measures. All clinical data were reported as Kaplan-Meier risk rates of first occurrence, per patient, in each cohort.
Results: Two-year follow-up visits were completed by 472 of 502 enrolled women (94.0%), 378 of whom had undergone primary breast augmentation and 94 of whom had received replacement augmentation. Patient-reported satisfaction with the outcome was 94.3% for primary augmentations and 92.3% for replacement augmentations; surgeon-reported satisfaction was also high (96.5% and 93.4%, respectively). Baker Grade III and IV CC rates were 3.8% (primary) and 8.2% (replacement), whereas moderate-to-severe wrinkling was 3.8% (primary) and 12.0% (replacement). Deflations occurred in
4.8% of primary augmentations and 3.3% of replacement augmentations. No deflations were caused by a shell fold flaw.
Conclusions: Two-year data from 472 women indicate that this double-lumen saline implant containing a baffle structure has a low rate of wrinkling and a lower rate of CC at 2 years than was reported for current single-lumen saline implants at 1 year.
Although saline-filled implants are a safe, effective alternative to silicone gel-filled implants,1 the currently available saline-filled implants are essentially balloons filled with freely-moving fluid, which may result in an unnatural feel or suboptimal aesthetic result.2-5 These implants, which have only a single lumen, tend to be less forgiving than silicone gel implants in terms of palpability, visibility, and rippling.5,6 Scalloping or wrinkling, for example, is a well known problem.5-7 This may be a significant part of the reason that 31% of women in the United States chose saline-filled implants for breast augmentation in 2011.8 For a more natural result, the only currently available alternatives to saline-filled implants are silicone gel-filled implants, which some women will not accept. Clearly, there is a need for a saline-filled implant that offers a more natural result, without the wrinkling, bouncing, or globular shape commonly attributed to current saline implants.2-5Continue reading “IDEAL Structured Breast IMPLANT®: 2-year Follow-up Study Results”→
Breast implant patients are eager to know more about the new Ideal Breast Implant, which is soon to be made available to the public. Dr. Larry Nichter, one of the lead FDA investigators into the safety and performance of the new implant, discusses the advantages offered by the latest breast implant in an interview with the American Society of Plastic Surgeons:
How is this implant superior to current saline or silicone breast implants?
The IDEAL IMPLANT was developed to combine the most desirable features of both current implants: the natural result of silicone gel with the safety of saline for “Peace of Mind.” It is what many women have been asking for – an improved saline implant, with the natural appearance and tissue-like feel of a silicone gel implant, but without the wrinkling, bouncing and globular look of the current single-lumen saline implant.
Why would a woman prefer this implant over current saline or silicone implants, or even future implants like the gummy bear silicone implants?
Many women considering breast augmentation would like to have only saline in their implants because of their feelings about health and safety. Scalloping or wrinkling is a well-known problem with current single-lumen saline implants. The only alternative women have for a more natural result is silicone gel-filled implants, which some will not accept, regardless of its “cohesivity.” This may be a significant part of the reason that 31% of US women chose saline-filled implants for breast augmentation in 2011. The IDEAL IMPLANT was designed to meet women’s need for an implant that gives a natural result, yet is filled with only saline.
Does the implant produce a more natural looking breast, as compared to current saline or silicone implants?
This new double-lumen saline implant was designed so the implant edge lies lower and closer to the convex chest wall, for a better contour to the chest wall than current single-lumen saline implants.
What are they made out of, i.e., do they still contain saline?
The IDEAL IMPLANT uses the same materials and manufacturing processes as current single-lumen saline implants. They are filled with only saline.
What is a double-lumen? What is an internal baffle structure and what is made out of?
Double-lumen means that the implant has two separate saline-filled lumens or spaces. An inner implant shell defines the inner lumen and the outer implant shell defines the outer lumen, which is between these two shells.
In the outer lumen, there are one to three implant shells, perforated and free-floating, that act as a baffle structure. This baffle structure is designed to control movement of the saline filler so there is no bouncing, to support the upper pole of the implant so it does not collapse when the patient is upright, and to support the edge of the implant so scalloping and wrinkling are minimized.
Does this implant look any different than current saline or silicone implants?
On the outside, it looks like any breast implant. On the inside, the IDEAL IMPLANT contains a series of implant shells of increasing size nested together (inner shell, outer shell and baffle shells in between).
Who is the manufacturer? Is this the first study done on this implant?
The manufacturer is Ideal Implant Incorporated, a company majority owned by plastic surgeons. The IDEAL IMPLANT is manufactured in the United States.
Is this the first study done on this implant?
Currently, where is this implants at in the FDA clinical trial process?
The PMA has been submitted to FDA in modules over the last year, including US clinical trial results, pre-clinical testing data and manufacturing information.
Approximately, how long until the implant will be available to patients?
FDA approval could be granted by year-end.
Will the cost of augmentation surgery with these new implants be comparable to current prices?
The IDEAL IMPLANT will be priced the same as current silicone gel implants and will be marketed directly to women. It will only be sold to ABPS certified plastic surgeons.
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
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.