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.
Dr. Nichter’s patient, Meredith, was featured on The Doctors to talk about her breast augmentation using the new IDEAL® Implant. The newest FDA-approved saline breast implant offers the safety of saline with the look and feel of silicone.
This is a very controversial topic with no clear answer. To my knowledge there is not a definitive study or consensus on this topic. Here is the background information: Breast implants (and other implantable medical devices) are widely believed to increase a patient’s risk of infection or capsular contracture from bacteria entering the blood stream (oral bacteremia) and settling on the implant causing an infection or capsular contracture. As dental treatment bacteremia is a rare cause of metastatic infections it makes it difficult to attribute causality.
Some surgeons treat their patients with prophylactic oral antibiotics in the period directly after breast augmentation with breast implants as well as for any procedure that causes transient bacteria, such as dental surgery, colonoscopy, urological procedures (e.g. cystoscopy), and gynecological procedures. Probably a single dose, one hour prior to the treatment followed by single dose after the treatment should be sufficient, as long as the patient is not immunocompromised.
Whether this should be done for the first 6 months to 1 year after the breast implant placement is unclear at best. To my knowledge, there isn’t any compelling data to support this. Intuitively many surgeons treat breast implants like other implantable medical devices like pacemakers and total joint replacements.
Even vaguer is dental cleaning. One could argue that we cause a bacteremia when we simply brush our teeth and so dental cleaning is only a more aggressive cleaning. Some surgeon’s recommendations may differentiate between superficial dental cleaning (no antibiotics) and deep cleaning and periodontal treatment (antibiotics therapy). There have been anecdotal reports of infection and capsular contracture following dental treatment. Therefore some plastic surgeons and patients after considering the risk of 1–2 doses of antibiotics vs the unlikely but potentially irreparable problems with your implant is worth the risk. As there is no great answer to this controversy, my recommendation is to follow the advice of your plastic surgeon and or other members of your health care team.
Cause: Large Implants due to their weight, gravity, thinning of tissues, chronically not wearing a bra, loss of elasticity and other factors may cause continued stretching so that your breast implant is no longer supported in its ideal position. This results in the progressive lowering of the inferior breast crease (inframammary fold). When the implant moves South to an undesired inferior position it results in the loss of volume and flattening of the upper pole of the breast, too much volume at the lower pole, increasing the distance from the fold to the nipple and finally the nipple position being abnormally high ( pointing up) and not centered. Similarly, the pocket can also stretch to the side (lateral) so that when lying down your implants fall towards your arm pits or sides, causing the “Side Boobs” appearance.
Bottoming out and Side Boobs Contributing Factors:
Implants placed above the pectoralis muscle
Chronically not wearing a bra when upright
Over dissection of the Implant Pocket
Large swings of weight including pregnancy
Skin and soft tissue laxity, loss of elasticity
Repair: Surgery is the only effective remedy. Revision surgery is almost always more complex than breast augmentation. Correction techniques vary based on your plastic surgeon’s experience and skill sets. Always choose a board certified plastic surgeon with expensive revision experience as even in the best of hands recurrence is frequent especially if larger implants are used. Repair techniques include some of the following techniques and recommendations:
Textured implants (“Velcro effect”)
Use of Smaller Implants
Maximum Submuscular Position (not just the pectoralis major but abdominis rectus below and serratus anterior on the side)
Capsulorrhaphy (tightening the pocket by sewing in-folded capsular tissue together)
Use of Biologic fabrics and other materials such as Acellular Dermal Matrix, “ADM” Alloderm, Strattice, “Silk” and others that can be used to reinforce the bottom of the pocket.
Change of position of implant to a new pocket location “neo pectoral pocket”
Internal Ryan Procedure (sutures binding the inferior mammary fold to stronger underlying tissues (e.g. fascial, periosteal)
Removal of Implants and replacement of volume using your own fat (Fat Transfer).
The procedure is performed under general anesthesia on an outpatient basis most often using an existing scar or making an incision beneath the breast. Recovery is similar to your original breast augmentation procedure. Use of taping after surgery and prolonged use of a support bra is often recommended. It is far more important to pick the best plastic surgeon rather than trying to pick the best procedure as they are in the best position to guide you to the right decision. See this article for help in selecting the best breast revision specialist.
It is very difficult to determine the exact size and shape implant you will require to best match your ideal breast image without an examination by a board certified plastic surgeon. Not just any board certified plastic surgeon, but one with many years of frequently performing breast augmentation surgery including different approaches, techniques and implant choices. This is because several measurements not to mention your breast characteristics are needed to determine the optimal implant size to obtain your goals. Without knowing these dimensions it would be difficult to make this determination. For example, the existing base width of your breast will determine, in many cases, the maximal volume per implant profile that you can accommodate. To illustrate; a 100 cc difference may make a significant difference with a narrow base width breast, but much less of a difference if you have a wide chest wall and wide breast “foot print”. Therefore, just because your friend may have a great result with let’s say a 350 cc implant to make her go from a “A” cup to a “C” cup size does not mean that you will have the same result with the same size implant. . Further simply placing implants in a bra to determine the size best for you is not always accurate as the bra often distorts the size, is dependent on the pressure the bra places plus the implant is outside your breast and not under it among other variables. Computer software morphing programs that automatically determine the best implant size can be helpful in some but not all cases (e.g. doesn’t work well in my experience with existing implants, sagging or asymmetric breasts). Using “want to be” photos however are useful if simply provided to the surgeon as I will further explain in a bit.
Additional critical decisions will also be made by your plastic surgeon such as: whether your implants will be above or below your pectoralis muscle. These choices are recommended to you based on the look you desire, the amount of sagging you may have, and other deciding factors. For more than 25 years, I have tried just about every method to best understand and achieve the patient’s optimal goal. The following is what I have found to be most accurate: To start with, I have found it most helpful for patients to bring in photos from my or other plastic surgeons’ websites to illustrate what they would like to look like. This gives me detailed standardized views and information both qualitative (shape, perkiness) and qualitative (size) and allows me to discuss with my patients how I can best achieve their objectives as well as realistic expectations. For example, though I always tell my patients that I cannot make them exactly the same as a photo because everyone has different anatomical constraints. However, these ”ideal” breast photos are brought to the operating room for reference during surgery so that I have the advantage of “seeing through my patient’s eyes” to best achieve their wishes. Even if the photo does not match their height or weight, I and most plastic surgeons are very good at translating the proportionality of the photo to your features.
I personally order more than one set of implant sizes and use sterile implant “sizers” (temporary implants) placed in the created implant pocket during surgery to know in advance exactly which implant would work best for you in both a sitting and lying down position. This also allows me the opportunity to modify the pocket to meet some of the more subtle shape features desired. This enables me to use my full artistic potential to achieve your desired goals.
Breast implant maker Sientra has announced their Capsular Contracture Care Program, the first of its kind in the industry. The C3 Program provdes breast implant patients with a guarantee beyond the standard manufacturer’s warranty. From Sientra:
Under the C3 program, a primary augmentation patient will qualify for a free replacement implant if she requires revision surgery to correct Baker Grade III or IV capsular contracture within the first two years after implantation.
Capsular contracture is an unusual response of the body to medical implants, including all types of breast implants. It involves tightening of the tissues around the implant, which makes the breast feel firm to the touch and possibly alter its aesthetics.
Sientra’s TRUE Texture™ implants were found to carry a significantly reduced risk of capsular contracture compared to its smooth implants, according to a study published this month in Plastic and Reconstructive Surgery. The analysis looked at more than five thousand implants over a five-year follow up process, providing a very robust set of data as a foundation for this finding. It is with this statistical confidence in the resilience of their textured implants against capsular contracture that Sientra introduces the C3 Program.
As with the implants themselves, Sientra’s C3 Program is only available through plastic surgeons certified by the American Board of Plastic Surgery. This is done to improve patient confidence even further — it ensures that surgical procedures using Sientra implants are only done by the most qualified doctors.
Dr. Larry Nichter is proud to offer Sientra’s implants at the Pacific Center for Plastic Surgery, as well as the C3 Program and the warranty that comes with all Sientra implants.
“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”→
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.
Dr. Larry Nichter of the Pacific Center for Plastic Surgery would like to make prospective breast augmentation patients aware that the FDA has approved a new silicone gel-filled breast implant made by Sientra, Inc. for use in the United States.
The implants will be available for women at least 22 years old seeking augmentation surgery, and women of any age seeking breast reconstruction surgery.
Silicone gel-filled breast implants are medical devices implanted under the breast tissue or under the chest muscle for breast augmentation or reconstruction. These implants have a silicone outer shell that is filled with silicone gel. They come in different sizes and have either smooth or textured shells.
This approval introduces a third company into the U.S. breast implant market, which previously consisted only of Allergan and Mentor.
The deputy director for for science at the FDA’s Center for Devices and Radiological Health, Dr. William Maisel, commented that although silicone gel-filled breast implants have demonstrated consistent safety, “It’s important to remember that breast implants are not lifetime devices. Women should fully understand risks associated with breast implants before considering augmentation or reconstruction surgery, and recognize that long-term monitoring is essential.”
The approval of these new implants follows a 3-year study involving clinical trials of the implants on 1,788 women.
As a condition of the approval, Sientra will carry out five- and ten-year studies into the long-term health effects of their implants.
Source: FDA – FDA approves new silicone gel-filled breast implant