New Evaluation Procedure for Multi-Dimensional Mechanical Strains and Tangent Moduli of Breast Implants: IDEAL IMPLANT® Structured Breast Implant Compared to Silicone Gel Implants

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.

Continue reading “New Evaluation Procedure for Multi-Dimensional Mechanical Strains and Tangent Moduli of Breast Implants: IDEAL IMPLANT® Structured Breast Implant Compared to Silicone Gel Implants”

Are Silicone Breast Implants Safe? An Update.

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.

Dr. Larry Nichter

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

References:

Functional Benefits from Tummy Tuck (Abdominoplasty)

Dr. Larry Nichter

A group of plastic surgeons believe that an abdominoplasty — commonly known as a tummy tuck — can now have functional benefits as well as cosmetic ones, particularly in the postpartum population.

A study recently published in Plastic and Reconstructive Surgery, the official medical journal of the American Society of Plastic Surgeons (ASPS), claims that abdominoplasty can help women deal with back pain and urinary incontinence (loss of bladder control) related to pregnancy.

The research group surveyed 214 women in Australia who were undergoing abdominoplasty at nine plastic surgery centers. The patients were looking to repair the muscles in the abdomen and restore its shape and appearance after pregnancy. It was found that a very large majority of women who had the procedure experienced less back pain and incontinence. The study authors suggest that the improvements may be the result of repair of the abdominal muscle separation (rectus diastasis) which is incorporated into the surgery.

Patient satisfaction has been high and chances of long term recurrence low.

References:

Best Cellulite Reduction/Treatment Options

Dr. Larry Nichter
Dr. Larry Nichter

Cellulite is a common term used to describe pockets of bulging superficial fat between fibrous bands that cause skin dimpling and lumpiness. It affects 80–90% of women but does occur rarely in men, even those on a healthy diet and of normal weight. There are many predisposing factors including hormones, genetics, weight changes, and even lifestyle. Cellulite most often appears on the buttocks, thighs, and hips. Its appearance is often called “cottage cheese-like, or “lumpy.” For several decades plastic surgeons and dermatologists have sought a means to predictably treat cellulite which can negatively affect a woman’s self-confidence, beach ware and clothing choices. Finally, and fortunately, there are some good means to minimize Cellulite.

Minimally invasive Options (No stitches required):

Cellfina uses a novel approach to standardizing treatments for more predictable results by stabilizing soft tissue with a vacuum device and guidance application system while the numbing solution is injected and bands are cut with a fine cutting needle-like scalpel that reciprocates dividing the fibrous bands that cause cellulite. In my experience the suction dramatically minimizes the discomfort of the entire procedure. It is a much quicker procedure than Cellulaze, and done under local anesthesia only taking thirty minutes to an hour depending on the amount of cellulite treated. It is the only FDA approved device for two or more years of cellulite reduction. As of this date, Cellfina has a 90% Worth It rating on RealSelf over 24 months. This is the best available treatment option for maximal results in my opinion.

Cellulaze employs a side firing laser to cut the fibrous bands causing skin dimpling from under the skin. As a laser is used, heat is produced which to a degree will cause fat to liquefy. It takes on average 1–2 hours when done under local anesthesia. It is highly dependent on the skill of the user. As of this date its Worth It rating on RealSelf is 54% over 24 months.

After both of these procedures:

  • Some bruising and discomfort are common and varies from person to person. For a few days, small amounts of fluid may leak from incision sites. Your physician may recommend use of a compression garment.
  • Return to normal activities after 1–2 days and resume strenuous exercise after 1–2 weeks.
  • Results will continue to improve for the next 3-12 months.
  • Results can be improved in many cases using additional non-invasive energy source options (Radiofrequency or RF, Laser or Ultrasound) following this procedure such as Velashape 3, ThermiSmooth, Thermage, Ulthera and Endermologie. The most effective of these in my experience is Velashape 3 and ThermiSmooth, and least effective in my opinion is Endermologie. There is no down time for non-invasive procedures.

Drains vs. Drainless Tummy Tucks

Dr. Larry Nichter
Dr. Larry Nichter

Your board certified plastic surgeon is the best person to ask for a specific recommendation if a drain is needed or recommended after your tummy tuck procedure.

I determine whether or not to use drains on a patient-by-patient basis. Often my decision is to use drains if liposuction is done at the same time as a tummy tuck or if an extensive tummy tuck is required, for example, following massive weight loss. In those situations I have found an increased chance of having a fluid collection called a seroma, or prolonged swelling, delaying the final result by weeks. Use of a temporary drain seems to prevent this from happening.

Those plastic surgeons that do not use drains for these more involved surgeries often rely on extra “quilting stitches” internally which lengthens the procedure and requires external elastic garments that may be uncomfortable. These garments, if too snug, can also apply too much pressure on the lower skin flaps, decreasing blood flow with delayed healing or other problems.

The purpose of drains is to remove excess fluid such as tumescent liposuction fluid, irrigation fluid, local anesthesia, blood/serum, etc., so that the superficial skin flap can touch the underlying deep tissue (muscle) to begin the healing process. With drains, I do not find it helpful to use compression garments or binders while drains are in place and sometimes not at all especially for “mini tummy tucks.” This is more comfortable for my patients.

Typically, drains are removed within 10 days but if you had significant liposuction done at the same time, it may be a bit longer. In general when each drain has less than 30 cc’s of drainage over 24 hours they are removed. Have trust in your surgeon’s recommendations but feel free to ask the rationale of their decision.

MiraDry Sweat Reduction

 

MiraDry Logo

MiraDry Sweat Reduction is a non-invasive, FDA approved technology which reduces underarm sweat through the use of an electromagnetic energy source to target the sweat glands. During the procedure, the doctor uses local anesthesia to numb the area to be treated and then places a temporary tattoo with square diagrams on the skin to mark the area. The doctor places the treatment device on each of the treatment squares so the energy waves move through the skin and dermis to hit the fat and bounce back. The energy waves collide with each other, creating heat at the fat and dermal junction. This destroys the eccrine and apocrine sweat glands as well as the hair follicles within the dermis. The skin itself remains undamaged because it is simultaneously being cooled through the device.

Am I A Candidate for MiraDry Sweat Reduction?

The ideal candidate for MiraDry Sweat Reduction is anyone who suffers from excess sweat or odor in the underarm area that comes from eccrine glands that cause wetness and apocrine glands causes bacteria that creates odors. People who can greatly benefit from this procedure includes firemen, military personnel, and police officers due to the fact that they must wear heavy uniforms in the heat.

Botox has also been used in sweat reduction treatment but it is only effective on eccrine glands and the results will not be as great if both sweat glands are not treated. A patient also needs to be treated twice per year with Botox to maintain the results at $1,000 per treatment, or $2000 total. MiraDry typically requires one treatment in a lifetime and the cost is between $2,000–$2,500.

MiraDry is also good for patients who want to reduce their amount of underarm hair. Although it can benefit patients of various hair colors, it is most useful on patients with light colored hair. For a woman with light hair, it might take two or three treatments to remove all the underarm hair. In general, this procedure is ideal for a woman looking to have less sweat, less odor and less hair.

Recovery and Downtime of MiraDry Sweat Reduction

The procedure is really a minor one so most patients can drive themselves home after their appointment. Although the downtime and recovery is minimal with this procedure, everyone heals in their own way. Some patients may require a little more recovery while others are playing golf two days later. Either way, a patient should expect some swelling and soreness for two or three weeks. Over the counter medications can be used to treat any discomfort. Some patients may experience a little numbness around the treated area that could last up to twelve weeks.

Results of MiraDry Sweat Reduction

Since the body has no way of regenerating the glands that are destroyed during the MiraDry procedure, this procedure is permanent for around 80% of patients. The other 20% will have a significant improvement but will need to have a second procedure to gain their ideal results by taking care of the sweat glands which were left untreated. This 20% of patients will attain lasting results as well with the second procedure.

MiraDry Sweat Reduction will not make the underarm area look or feel too dry. There will still be some moisture so that the underarm feels normal to the patient. However, the dripping is alleviated and there are no sweat stains to worry about.

Limitations and Risks of MiraDry Sweat Reduction

Even though a person might suffer from sweaty hands or other sweaty areas, MiraDry Sweat Reduction is limited to the armpit area. There are too many risks of nerve damage when using MiraDry in other areas of the body due to the nerves being close to the surface of the skin.

During the earliest MiraDry Sweat Reduction procedures, only small amounts of local anesthesia were injected. This small amount caused incredibly thin patients to experience temporary nerve weakness as well as pain and discomfort. As the procedure developed and improved over time, a tumescent technique similar to the technique used during liposuction was adopted and greatly reduced the risk of pain and nerve weakness

Sweating Elsewhere in the Body

Dr. Larry Nichter
Dr. Larry Nichter

MiraDry Sweat Reduction has been used by doctors on patients in over 55,000 treatments all over the world. It’s important to note that humans are born with almost 2-million sweat glands located throughout the body. The underarm area only contains around 2% of the 2-million sweat glands in the body. Even though this procedure helps patients achieve relief by giving them dry underarms, they will continue to perspire as normally as before elsewhere in the body.

Written by Cosmetic Town Editorial Team -SP
Based in an exclusive interview with Larry Nichter, MD in Newport Beach

The IDEAL Structured Breast IMPLANT®

ideal-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®

IDEAL Structured Breast IMPLANT BafflesAn 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.

IDEAL Breast Implant

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

Dr. Larry Nichter
Dr. Larry Nichter

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

Breast Reduction: Determining Optimal Amount/Weight to Remove

Dr. Larry Nichter
Dr. Larry Nichter

Breast Reduction is a complicated procedure that is best done by those with the most training and experience. It is very difficult to determine the resultant cup size and shape based solely on the number of grams that are removed from your breast 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 reduction and lift surgeries, including different approaches, techniques and even fat transfer and implant choices if you are lacking superior breast fullness.

This is because several measurements—not to mention breast characteristics such as density—are needed to determine how much and where to remove breast tissue to meet your goals. Without knowing your existing breast shape, dimensions, and the density of your breast tissue, it would be difficult to make this determination. For example, the same volume of breast tissue will weigh different amounts (measured in ounces or grams) in different people depending on its density. The existing base width of your breast and what you will ultimately want to look like will determine, in many cases, the maximal volume and weight that will need to be removed for the best result.

To illustrate: removing 300 grams of breast tissue may make a significant difference in cup sizes (e.g. 2–3 cup sizes) with a narrow base width breast, but much less of a difference (e.g. Perhaps 0.5–1 cup size less) if you have a wide chest wall and wide breast “foot print”. Your friend may have a great result from removing 500 grams of breast tissue to make her go from a “DDD” cup to a “C” cup size, but this does not mean that you will have the same result with the same weight of breast tissue removed.

To make matters even more complicated, different bra manufacturers have different cup size labels for the same breast size. Computer software morphing programs that automatically determine what you may look like after a breast reduction can be helpful in some but not all cases (e.g. doesn’t work well in my experience with sagging or asymmetric breasts). Using “want to be” photos however are useful if simply provided to your surgeon in advance for preoperative discussion.

Personally, 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 quantitative (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, your “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 and will try our best to match your goals. For assistance in finding the best Breast Reduction plastic surgeon see this article:

Picking the Best Plastic Surgeon: Finding Dr. Right

Breast Implant Rippling and Strategies for Correction

Dr. Larry Nichter
Dr. Larry Nichter

Breast Implant Rippling most often occurs when there is insufficient soft tissue coverage due to little overlying body fat and breast tissue. Implants placed beneath the muscle help to minimize this phenomena but the lower and outside breast (as pectoralis muscle is no longer present), towards the cleavage where the muscle thins out or on top of the breast where breast tissue is often lacking are the most common places to see rippling. It is often accentuated with certain positions (e.g. bending over,or leaning). Most of the time, rippling is felt along the outer side of the breast and the inner side of the breast next to the cleavage. Breast implant waviness (rippling) that is felt but not noticeable to the eye is very common and should not be a concern. However, when rippling is visible, patients are often self-conscious about their appearance.

Factors that are associated with increased rippling include:

  • Traditional Saline implants (IDEAL® Saline implants less likely)
  • Textured implants
  • Large implants
  • Thin patients with low BMI
  • Implants placed above the muscle
  • Prior history of rippling

Factors which are less likely to have rippling include:

  • Heavier and larger breasted women
  • Using a highly cohesive form-stabile silicone implants (gummy bear)
  • Smooth implants
  • Smaller implants
  • Submuscular placement

Once rippling occurs it is very difficult to correct. Rippling can be minimized by placing a biologic fabrics (e.g. AlloDerm®, Strattice™, SERI®), submuscular conversion if implants are above the muscle, fat transfer, use of adjacent tissue (muscle or fascia) if available, and in persistent cases implant removal and fat transfer. Seek the care of the best board certified plastic surgeon possible with experience in breast revision surgery.

Best Mommy Makeover Options

Dr. Larry Nichter
Dr. Larry Nichter

For women, having a child life-changing event. The capability to create, foster, and give birth to a child of your own distinguishes women in the human species. The nine-month transformation from a tiny embryo to a human being in itself is a magical event, but it transforms the mother’s body as well, often in a non-favorable direction. A mother goes through many different changes during pregnancy and the birth process. In many cases, areas of a woman’s body may not return to the same shape prior to pregnancy.

Thanks to current medical procedures, mothers are often able to restore their bodies back to their pre-birth shape or even better. After breast feeding is complete and you have fully recovered from pregnancy, there are various steps that can be taken to get your body back into shape. In what is commonly known as the Mommy Makeover — various procedures such as breast augmentation, breast lifts, liposuction, tummy tucks, fat transfer, and other procedures — can be done to get your body back into top condition. Most of these procedures can be done in combination to complete your makeover or can be done in separate steps.

Breasts

In most cases after childbirth, women often find that their breasts become out of shape due to breast-feeding or growth then shrinkage after pregnancy. The breast often loses volume on the top and sags and becomes less firm and out of shape (post-partum involution). This can produce visual changes that women want to fix and improve. With straightforward procedures, breasts can be transformed to the desired state with a variety of techniques including breast augmentation using fat transfer (called California Breast Lift in my practice) or implants with or without a lift. These procedures can give your breasts a natural look and maintain volume that was present prior to pregnancy. Some surveys have stated that up to 90% of patients have found success with these procedures, with remarkable results and happiness.

After breastfeeding and childbirth, mothers often find that excess skin results or the skin around the breasts is loose resulting in sagging. In these cases, a breast lift can also be done to reshape the skin envelope and uplift the areola/nipple position. By itself, this procedure isn’t done to change the size of the breasts, but is done more to affect the contour and firm up the breast skin and underlying breast tissue. Newer, minimal scar breast lift techniques, can affect the breast size if combined with a breast augmentation or reduction procedure to enhance the shape, size, and position of the breasts.

Tummy and Hips

Following pregnancy, women often find that the tummy and hip areas are the main concerns for improvement following delivery. After giving birth, women often try to return to their pre-baby weight and find that even if they lose those pregnancy pounds, that they cannot get their tummies back into the desired shape. A tummy tuck with or without liposuction can be performed in this case to remove excess skin, fat, and tone up your tummy muscles. This tried-and-true procedure in the hands of an experienced plastic surgeon will result in a firmer and smoother stomach. Weakened, stretched, and separated muscles (Diastasis Recti) are reshaped during this procedure and will transform your abdominal wall into a well-toned tummy. Giving birth can result in your abdominal skin and muscles being stretched out of shape. A tummy tuck will reshape it back into its toned natural shape, sometimes even better than before you were pregnant. Liposuction is often done at the same time and the fat removed can be used by transferring it to areas that may have lose volume such as your buttocks (Brazilian Butt Lift) or breasts.

Skin

Most women following pregnancy will get stretch marks but this doesn’t mean you can’t do anything about them. Stretch marks, also called striae, can also occur as a result of pregnancy. The tummy tuck not only reshapes the stomach muscles and skin, but also removes these a large number of stretch marks below the belly button. Certain lasers are also available that can get rid of the redness and shrink the width of stretch marks while improving the texture of your skin. Spider veins or red spots (angiomas) following childbirth can vanish seemingly instantly with special lasers and without downtime afterwards. Prominent superficial veins in the legs and other areas also can occur after having a baby. These can be treated in the office with lasers and injections (sclerotherapy).

Skin tone and texture can also be improved. For example, Cellulite and skin wrinkling can be tightened noninvasively. Likewise, circumferential reduction of the waist and thighs with a series of non painful, non-invasive treatments combining the energy sources of RF (radiofrequency), IR (infrared) aimed at improving the skin and superficial fat (e.g. Velashape III).

Fat

After pregnancy and with age, fat can accumulate in different areas that are resistant to diet and exercise. In concert with the Velashape® treatments, Liposuction or other non-invasive non-surgical fat reduction procedures are often helpful. Whether it’s the tummy, hips, thighs, back, or upper arms, liposuction can get rid of the excess fat collection that occurs after pregnancy. By getting rid of these excess bulges along with a sensible diet and exercise plan, you can get your body back into top shape. Other non-invasive techniques such as CoolSculpt® and newer techniques such as Ultrashape®, and Vanquish® are all possibilities for non-surgical fat reduction. As all techniques work differently make sure you go to an expert plastic surgeon to decide which is best for you. These techniques reshape your skin and body towards to your desired shape and best of all there is no down time and minimal if any discomfort. With regular core exercises, you are well on your way to an “abs of steel six-pack”. Exercise maintenance and a stable weight should give you a life-long result.

Belly Button

Another part of the body that might be affected post pregnancy is the belly button, also called umbilicus. The pregnancy cycle can stretch or distort the belly button area. The tummy tuck can assist with making your belly button smaller, however if this is your only concern, improving your belly button’s appearance via a procedure known as umbilicoplasty is possible. An umbilical hernia usually recognized by an “outie belly button” can also be repaired at the same time and often performed under local anesthesia as an office procedure.

Vaginal and Labial Rejuvenation

Especially following vaginal delivery, and important to femininity and intimacy, sometimes the vaginal area is stretched out and loses optimal tone. This can be corrected with a vaginoplasty to firm up and increase tone to the vaginal canal, giving increased intimate sexual satisfaction to the woman and her mate. Likewise, the labia minora (inner lips) might be overly large as a result of pregnancy or genetics. Labia reduction is corrected with a procedure called labiaplasty. The mons pubis, hair bearing area, often becomes bulky, sags, and shows through clothes following pregnancy. This can be corrected with a “monsplasty” procedure. These procedures are often performed as an outpatient procedure, often at the same time as other mommy-makeover procedures.

Skin Pigmentation

Lastly, persistent darkened skin pigment changes may occur on your face, also called Chloasma or Melasma (“mask of pregnancy”). Tailored medical grade lightening creams, peels, and lasers can be done to help with the discoloration that can occur following pregnancy in the facial and other areas.

Conclusion

All of these mommy makeover procedures and others are done in an effort to regain your ideal image, shape and composure following pregnancy. Just because you’ve had a baby, this doesn’t mean your body should be neglected. You can choose from a combination of procedures to get your body back into shape, firmer, and smoother following pregnancy. As always, consult an experienced board certified plastic surgeon before any procedure, discuss treatment options, as well as recovery time, risks, and possible non-surgical alternatives to surgery. Where the gift of lift is a wonderful thing, a mommy makeover can be the best gift you give yourself after pregnancy.