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.
This brief review will bring to light some of the recent information concerning the relationship between silicone gel implants and Breast Implant Associated Illness up to the current date: 2019.
Breast implant surgery has been around for several decades and was the most common plastic surgical procedure in the US in 2017 with more than 300,000 patients having cosmetic breast augmentation. In addition about 100,00 breast reconstructions with implants are performed annually. Whether used for augmentation, replacement, or reconstruction, the majority of breast implants used in the U.S. and worldwide are silicone gel implants. Most women with silicone gel breast implants are satisfied with their result and their decision to have this procedure and do not suffer from associated illness. There is however, an ongoing controversial history regarding Breast silicone gel implant safety and especially more recently, textured implants with regard to implant associated illness . In the 1980s to 1990s, many thousands of women blamed silicone breast implants as a cause for many maladies including autoimmune disease and breast cancer. As a result in January 1992, the FDA issued a moratorium on the sale of silicone gel implants and only allowed saline implants for sale for first time cosmetic augmentation patients for the next 14 years. Soon thereafter Dow Corning, a prominent breast implant manufacturer filed for bankruptcy, in part due to massive legal liability despite prior evidence indicating that breast implants were not linked to any disease processes. In 1999 the Institute of Medicine (renamed National Academies’ Health and Medicine Division) independent experts concluded that though frequent complications from breast implants occur, there was no link to other medical conditions such as cancer, connective tissue disease, autoimmune disease, or other systemic illness. Simply put, these illnesses were “no more common in women with breast implant than in women without implants”. As a result the FDA advisory panel voted in a 5 to 4 decision, to allow silicone implants back on the market in 2006. This was a controversial decision and the Panel’s chairman, Dr. Whalen, in protest, resigned noting “To approve this device poses threats to women that are clearly unknown”. Debate continued and in November 2006 the FDA finally gave approval for silicone implants, made by Allergan and Mentor, to be made available in the U.S. for all appropriate patients over the age of 22 years old. It did so with the proviso that both companies were to conduct prospective large post implant approval studies over a 10 year period that included imaging surveillance, long-term safety issues including device-failure studies, as well as possible systemic harm due to silicone such as autoimmune and other disease processes. The FDA also warned that the risks of silicone gel implant complications are high and “you should assume the you will need to have additional surgeries”. Unfortunately, there was poor follow-up compliance in these study groups and after 2 years only 40% of Allergan subjects and after 3 years only about 20% of Mentor subjects remained in the study. It was on this basis of the available information, that I and other board certified plastic surgeons shared this limited available information with our patients; that though local complications can occur (rupture, capsular contracture, bleeding, numbness, etc) and that all breast implants whether silicone gel or saline would not last forever, most likely would have to be replaced and that they did not cause other disease processes.
Still, I and other plastic surgeons, over the years, would see increasing number of patients with ill defined problems and symptoms often involving connective tissue and autoimmune conditions that my patients and occasionally other medical doctors felt might be related to their silicone implants More recently, there is a growing body of evidence in the scientific literature linking silicone gel but not saline breast implants to autoimmune disease, and a growing number of Breast Implant Related Illnesses and symptoms. A systemic review of the literature was published in 2016 in Annals of Internal Medicine noting possible decreased risk for primary breast and endometrial caners but increase risk for lung cancer, rheumatoid arthritis, Sjogren syndrome, and Raynaud syndrome. However the authors concluded that the “evidence remained inconclusive about any association between silicone gel implants and long-term health outcomes. Better evidence is needed from existing large studies, which can be reanalyzed to clarify the strength of associations between silicone gel implants and health outcomes”. In the interim, after the FDA tightened reporting rules for enforcement in 2017, breast implant related conditions dramatically increased up to 20 fold. For example from less than 200 per year of possible breast implant related illness to greater than 8200 in the first half of 2018.
Still, an associated link to disease for silicone gel implants could not be made. This is because there was not enough cumulative data statistically analyzed to support the notion of “Breast implant Illness” until 2018. The post approval ten year FDA study of Silicone Gel and Saline implants was completed in 2016. This was the largest study of breast implant outcomes to date. MD Anderson Medical Center in 2018 reviewed the FDA study data of nearly 100,000 women with breast implants and published their findings in Annals of Surgery in the fall of 2018. They came to the following conclusions: Silicone gel implants but not Saline Implants are associated with Sjogren syndrome, Scleroderma, Rheumatoid Arthritis and Melanoma greater than double the general population risk. This supported the association in the literature review article in 2016. mentioned above. It should however be noted that despite this relationship, all are relatively uncommon processes. At about the same time, in October 2018, an article in the International Journal of Epidemiology was published titled “Silicone breast implants and the risk of autoimmune/rheumatic disorders: a real-world analysis”. This was a cross-sectional retrospective study in Israel analyzing computerized data, up to 20 years, and included nearly 25,000 silicone breast implant patients which they compared to nearly 99,000 matched women without implants. Their study demonstrated an association between silicone gel implants and the presence of autoimmune/rheumatic disorders. Of these, Sjogren’s syndrome, systemic sclerosis and sarcoidosis were most strongly associated with silicone gel implants. Other diagnoses such as fibromyalgia/chronic fatigue syndrome, hypo and hyperthyroidism, psoriasis, and being diagnosed with at least one autoimmune/rheumatic disorder was also noted to be more common in silicone gel implant patients regardless of reconstructive or cosmetic reasons for their silicone gel implants. Again, there was only a link to silicone gel implants and not saline implants. An important point of clarification needs to be made: these studies noted an association or correlation rather than causation. This means researchers found a relationship between different variables they were studying but and did not definitively conclude that the silicone gel implant was the definitive cause of these maladies, though this may be the case in the future pending and subsequent research studies. The American Society of Plastic Surgery (ASPS) and American Society for Aesthetic Plastic Surgery (ASAPS) have been closely monitoring adverse events associated with all types of breast implants. An ASAPS committee investigating this problem is finding a similar number of both saline and silicone implant patients have reported similar illness diagnosis and symptoms.* In interpreting this data one must take account of the moratorium on the use of silicone implants for 14 years (1992-2006) for aesthetic patients up until 2006. This means that approximately 4 million or more saline implant patients than silicone gel patients took place during this long time period. It is also likely that a time delay is present before symptoms or illnesses may be manifested. Therefore, if there was an equal likelihood for an illness to occur with both types of implants, theoretically there should be far greater saline associated illnesses than silicone. This is not the case. If in fact the number of these problems is similar, this infers there is a much greater likelihood that silicone gel implants have a higher associated incidence for these problems.
Perhaps the large scale study that may be most important and still needs to be done is to focus on those women with ruptured gel implants to answer the question if the risks of rare diseases would be even higher and prove causality. Unfortunately, this is a difficult study to do as few women follow the FDA guidelines to monitor their silicone implants with a MRI scan at 3 years then every two years (estimated at less than 10%) to make sure their implant is not ruptured. As a ruptured implant often does not cause symptoms (silent rupture) there maybe more than 150,000 women in the U.S. with ruptured implants and don’t know it. (assumes 2017 ASPS & ASAP statistics with 1% rupture rate per year and that most do not have MRI exams).
Recently, textured implants, both silicone and saline textured devices, have been found to be associated with late seroma, double capsule formation, and more importantly, a rare form of cancer called Breast Implant Associated Anaplastic Large Cell Lymphoma, BIA-ALCL. BIA-ALCL is a rare cancer, different from breast cancer, and usually curable with surgery. It is exclusively related to textured implants. Textured silicone gel implants are the most common round implant used in Europe, Central and South America and other regions and thought to have lower capsular contracture rates especially in subglandular position (above the muscle). All shaped silicone gel implants, for example, are textured. Reports of BIA-ALCL are from all companies in the USA though most cases to date are those made by Allergan and maybe related to their unique aggressive textured surface characteristics. As of this date there have been 615 identifies cases worldwide. Recently France banned Allergan’s Microcell and Biocell textured breast implants due to safety concerns and shortly afterwards in December 2018 Allergan stopped sale of their textured implants in the European Union. The exact incidence of BIA-ALCL is unknown until larger studies over a longer time line occur as there is a median of about 8 years post implant placement for ALCL to occur. In Australia for example, the incidence is somewhere between 1 in 1,000 to 1 in 10,000 but has been reported at a much lower rate than other countries. In the U.S. currently estimate at about 1:3800-1:30:000 but the incidence may increase with increased reporting and time. Note these only occur with textured primarily silicone gel implants and have not smooth silicone or saline implants. BIA-ALCL Symptoms may include breast enlargement, asymmetry, lump in breast or armpit, pain, overlying rash, breast hardening, or late larger fluid collection typically more than one year after implant placement. Diagnosis is made by analyzing the seroma fluid or by biopsy with specific CD30 immune staining tests. If positive a PET/CT scan is recommended to determine the extent of disease which will guide treatment. An oncologist will most likely be involved at this point. Fortunately, simply removing the implant and surrounding capsule (capsulectomy) is curative in most, but if BIA-ALCL is spread to lymph nodes or other body areas than chemotherapy is required. Post operatively, regular follow-up imaging studies for a few years to make sure there is no recurrence is typical but varies from case to case.
There are many myths being circulated in part by uninformed consumers, non-plastic surgeons and even plastic surgeons and medical societies that are misleading. Perhaps the most pervasive ones are that since the shell around saline implants are made of silicone, there is no additional risk or difference between a silicone gel or saline filled implant from your body’s standpoint. Further, a similar myth that since implants after 2006 are now cohesive and in particular highly “cohesive,” or “gummy bear” implants do not leak or rupture due to its semisolid nature, will last a lifetime and never need to be replaced. In reality, silicone gel even if cohesive is a mixture of silicone molecules of different lengths. The gel itself is sticky and adheres to the capsule. Short chain molecules (oils) can then migrate out of the gel with a broken shell. There is about 1-2% rupture rate per year of silicone gel implants including highly cohesive, “gummy bear” type in the first decade depending on the manufacturer then presumably a higher incidence after a decade.
Even without symptoms of breast implant related illnesses about 20% of women with silicone gel breast implants have them removed within a decade due to deflation, capsular contracture (distortion and hardening often with pain), fear, or other reasons. Silicone gel implant Deflation/Rupture at 8 years occurs between 7%-14% and Significant Capsular Contracture (Grade 3-4) ranges between 11-16% (FDA Core Trial Data) are most common reasons for removal.
So what are the safest and best options available?
These vary from person to person and it is best to discuss your goals and concerns with a board certified plastic surgeon by the American Society for Plastic Surgery experienced in both primary and revision breast cosmetic and reconstructive surgery. I will focus on some of the more common pragmatic choices that I provide to my patients which I feel is a combination of safety and overall minimizing the number of surgeries required during their lifespan. These are my personal biases and rationale for my recommendations from more than 30 years of practice. There is no singular right answer for everyone and I respect and acknowledge that other plastic surgeons will give alternative meaningful advice they feel are in their patients’ best interest with solid rationale based on their experience and individual research and reflection.
Implant Choice: If you wish to have an implant whether it is your first time, replacement, revision or coupled with other procedures such as a lift, reduction or augmentation I recommend the IDEAL Structured Implant® which is an engineered structured saline implant to feel like silicone but with safety profile of saline. As a FDA investigator for this implant, I have followed my patients for more than 9 years and have published and reported nationally on the comparison of this implant to silicone gel implants. To begin with IDEAL® implants have 3-6 times less deflation rate than silicone gel implants (2% at 8 years) and significantly lower capsular contracture rate than gel implants ( 6.5% vs 11-16%) while at the same time having the feel of silicone. It is not to be compared with, nor the same, as traditional saline implants which I do not prefer due to increased rippling and unnatural feel. IDEAL Implants® look and feel like silicone in my experience. IDEAL implant® monitoring is simple; just look in the mirror to see if your implant is intact rather than worry about silent rupture and the need, expense and hassle for repeated MRI scans. As the contents are only saline, it is absorbed. Since the shell is smooth, presently there is no risk for ALCL, nor are there any know associated risks with breast implant related illnesses which are to date only associated with silicone gel implants. Although I recommend to my patients with silicone gel implants that they should consider replacing their implants after 10-12 years (as rupture rates are relatively high) or whenever they are told they have a rupture, with IDEAL® implants there is no need to monitor or replace them unless there is a problem which will result in significantly less surgeries in their lifetime. When a silicone gel implant rupture occurs a longer and more expensive capsulectomy procedure is required, vs when simply replacement if an IDEAL implant® ruptures.
No Implant Choice: If you do not want to use an implant, wish to have yours removed but still wish to have increased breast volume, consider using your own fat to do the job. If you have sufficient fat in unwanted places, a fat transfer to the breast using your own tissue may be a good option for you. This has become so popular in my practice that we coined the term “California Breast Lift®” Patients are thrilled with removing unwanted fat, the perk of a smaller waist line & pants/shorts fitting slimmer and not having to worry about implant issues in the future. If you believe you are suffering from a breast implant related problem or illness and/or want your implants removed this may be a good option for you.
If your silicone gel implant is ruptured, an en bloc capsulectomy is customarily performed to remove as much of the silicone gel traces as possible. If you do not wish to use your own fat or have insufficient fat then simple removal, explantation with or without a capsulectomy, or lift (mastopexy), can be performed if desired. Your board certified plastic surgeon will guide you through this decision making process.
In summary, for the majority of women with or considering breast implant surgery whether it is for augmentation, replacement or removal, be aware of all of your options, potential risks and benefits of the procedure and search for the best and most experienced board certified plastic surgeon in your area. Let him or her know your concerns and be prepared to ask questions about risks, complications, and options to be fully informed. Although silicone gel implants seem to be associated with a number of illnesses and many complications, most women are spared and satisfied with their choice. Fortunately there are other options such as the IDEAL Structured Implant® and using your own fat (“natural breast augmentation,” California Breast Lift®) or simple removal (explanation) with or without a lift which can reduce or eliminate these concerns.
Larry S. Nichter, MD, MS, FACS
Balk EM, Earley A, Avendano EA, et al. Long-term health outcomes in women with silicone gel breast implants: a systematic review. Ann Intern Med. 2016;164:164–175.
Coroneos CJ1, Selber JC, Offodile AC 2nd, Butler CE, Clemens MW. US FDA Breast Implant Postapproval Studies: Long-term Outcomes in 99,993 Patients. Ann Surg. 2019 Jan;269(1):30-36
A. Watad, V. Rosenberg, S. Tiosano, J.W. Cohen Tervaert, Y. Yavne, Y. Shoenfeld, V. Shalev, G. Chodick, H. Amital. Silicone breast implants and the risk of autoimmune diseases: real world analysis. Int J Epidemiol. 2018 Dec 1;47(6):1846-1854
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
Women wanting breast augmentation have until now faced a dilemma: a choice between safer but less natural-feeling saline implants, and more natural-feeling silicone implants which are perceived to come with health risks.
The Ideal Implant®, a new breast implant soon to be made available to the public, promises to change all of this. The Ideal Breast Implant is a saline implant with the natural feel of a silicone implant made possible by its innovative double-lumen design. This design consists of a series of nested shells which control the flow of liquid inside the implants, giving them a more realistic feel than standard saline implants.
The Ideal Implant has completed its two-year trials with stunning results. Of the 472 women who came in for two-year follow-up examinations, patient satisfaction for those who received the Ideal Implant as their first implants was 94.3%. Satisfaction among women who received Ideal Implants as replacements for their previous ones was 92.3%. Surgeon satisfaction with the results was also high (96.5% for primary implants and 93.4% for replacements).
Dr. Larry Nichter, one of the surgeons assessing the new implants for the FDA, comments very favorably on the new breast implants in a press release by the American Society for Aesthetic Plastic Surgery:
“The two-year clinical data from this study show that the Ideal Implant may provide a good alternative to current saline- or even silicone gel-filled implants. One of our most significant and unexpected findings was the low rate of capsular contracture for the investigational, double-lumen implant compared to current single-lumen saline implants.”
The Ideal Implant’s two-year statistics for capsular contracture were better than those for regular saline implants at one year, and none of the small number of deflations were caused by shell fold flaws.
As a further guarantee of quality and safety, the Ideal Implant will only be available through plastic surgeons who are certified by the American Board of Plastic Surgery, which is the only plastic surgery board recognized by the American Board of Medical Specialties. This means that women who choose the Ideal Implant will automatically be choosing from among the best plastic surgeons in the United States.
To receive updates about the ideal implant or to be placed on Dr. Nichter’s waiting list for the procedure, please contact our office using the form below.
“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.