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 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.

Capsular Contracture: Prevention and Treatment

Dr. Larry Nichter
Dr. Larry Nichter

Although capsular contractures following breast augmentation can occur just about any time, most women start having symptoms around three months after their breast implant surgery. This is because it takes some time for a capsule to form and then to scar down (contracture).

Capsular Contracture is a condition in which the capsule surrounding the implant thickens and contracts, squeezing the implant making it overly firm or hard and often changing the shape and position of the implant. As the capsule contracts it moves the implant further up your chest wall making upper portion of your breast too large and unshapely. It is more far more common in nicotine users (e.g. smoking, vaping or nicotine gum or patches).

Treatment for capsular contracture often involves en bloc capsulectomy, complete removal of the capsule, or making the pocket larger by capsular incisions (capsulotomy) with implant replacement. Recent studies suggest that using the same implant may increase the chance of recurrence. Placement of the implant in an new pocket is also often done as well as using textured implants. In the past, closed capsulotomy, in which the breast is squeezed until the capsule breaks, was used but has been associated with implant rupture and other complications and few surgeons use this technique any more not to mention that your warranty will be void. On occasion, the use of a biological fabric like Strattice or Acellular Dermal Matrix (ADM) may be required to prevent continued problems. Although the published risk of capsular contracture is approximately 9–11%, in my practice it is significantly lower after the primary implant placement. Once capsular contracture occurs, the risk of problems with secondary surgery rises to between 25% and 40%. Capsular contractures are lower with non-smokers, and with use of textured silicone implants placed below the muscle. The location of the incision also plays a role. Inframammary incision also has the lowest and periareolar and axillary (arm pit) incisions have the highest capsular contracture rate. Smoking/nicotine use greatly increases your risk for capsular contracture greater than 10 times the incidence of a non nicotine user.

Non-surgical management includes prophylactic massage to prevent it and if it occurs, the use of certain anti-asthma medications: Singulair and sometimes Acculate as off-label FDA usage to treat Capsular Contracture and in some cases of recurrence of capsular contracture in a preventative fashion. In my experience this works best for early diagnosed early contractures and used as a prophylactic, perioperatively when doing a capsular contracture surgery. The price for capsular contracture surgery varies greatly by geographical location, experience of the surgeon, whether in an outpatient surgery center vs hospital (hospital more expensive), type of breast implant, whether it is ruptured or not, estimated length of operating room time, and other factors.

‘Bottoming Out’ and Lateral Displacement of Breast Implants Explained

Dr. Larry Nichter
Dr. Larry Nichter

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:

  1. Larger/Heavier Implants
  2. Implants placed above the pectoralis muscle
  3. Chronically not wearing a bra when upright
  4. Over dissection of the Implant Pocket
  5. Smooth Implants
  6. Large swings of weight including pregnancy
  7. 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:

  1. Textured implants (“Velcro effect”)
  2. Use of Smaller Implants
  3. Maximum Submuscular Position (not just the pectoralis major but abdominis rectus below and serratus anterior on the side)
  4. Capsulorrhaphy (tightening the pocket by sewing in-folded capsular tissue together)
  5. 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.
  6. Change of position of implant to a new pocket location “neo pectoral pocket”
  7. Internal Ryan Procedure (sutures binding the inferior mammary fold to stronger underlying tissues (e.g. fascial, periosteal)
  8. 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.

Breast Augmentation (Mammoplasty)

Overview

Dr. Larry Nichter
Dr. Larry Nichter

Many women who would like to restore or enhance the size and shape of their breasts may benefit from breast augmentation, also known as mammoplasty. It is one of the most common procedures performed annually by members of the American Society for Aesthetic Plastic Surgery. Breast augmentation is performed to enhance the breast size and shape due to lack of development, congenital abnormalities, changes or asymmetries following aging, weight loss, and/or pregnancy. In addition, there may be personal reasons for augmentation mammoplasty. For example, some women may perceive their breasts to be underdeveloped and not proportional to their body size and image they wish to project. Women may also decide on breast augmentation, though they may be happy with their breasts, just because they would like them to be fuller. A positive impression of their body image is important to most women, and breast augmentation may aid in offering a more proportional breast size and shape as well as in improving self-confidence.

Would I be a good candidate for breast implants?

A variety of factors may indicate that you are a good candidate for breast augmentation. Some of these feelings and/or conditions include:

  • You feel bothered and/or have low self-esteem that your breasts are too small.
  • After giving birth, your breasts have become smaller and have lost their firmness.
  • You notice that clothes that fit well around your hips are too big at the bust line.
  • You feel self-conscious when wearing a bathing suit or other form-fitting apparel.
  • A weight loss/fluctuation or pregnancy has changed the shape and size of your breasts.
  • There is an asymmetry where one of your breasts is noticeable smaller than the other.

How does the procedure work?

Breast implant surgery is accomplished by surgically inserting either a silicone or saline implant (prostheses) behind each breast. The breast implants are placed either in front or behind the pectoralis major muscle and breast tissue. General guidelines suggest that women with larger drooping (ptosis) breasts that do not want a breast lift should have the implant placed above the muscle to prevent contour problems (double contour deformity). Those patients with minimal breast tissue usually have the implants placed beneath the pectoralis muscle for more soft tissue padding. In any case, your plastic surgeon will determine which placement is best for you and explain why. When you come in for a consultation, the different options will be explained in further detail as well as the three choices of implements currently available: silicone, standard saline, and IDEAL® double lumen saline implants (a new double lumen saline implant made to feel like silicone).

Is the procedure safe?

For the vast majority of patients undergoing breast augmentation, the procedure is extremely safe and involves minimal side effects. In my practice using board-certified anesthesiologists and FDA approved prostheses are always employed to ensure a successful surgery. A general anesthetic is used but a local anesthetic is also placed prior to awakening for postoperative pain relief. The implants, breast prostheses, are made of safe, non-reactive silicone material which have been studied by the FDA and worldwide, and used since the 1970’s. So much so, in fact, that they are the most studied medical device in the world. There is no link to date between silicone prostheses to other diseases like auto-immune disease, arthritis, cancer, or other connective tissue diseases. These problems occur to the same extent and at the same rate in women with breast augmentation as those who have not had the procedure. For instance, cancer occurs just as frequently in women with augmented breasts as it does in those with natural breasts.

What choices do I have with my breast augmentation?

Breast implants come in a variety of shapes, sizes, firmness and profiles in order to offer a custom-fit and natural-looking physique. It is also important to consider the substance and texture of an implant. The surface of round implants can be smooth or textured whereas shape implants are all textured to maintain their alignment. In particular, those implants approved by the U.S. Food and Drug Administration (FDA) are filled with silicone or saline. All implants at this time use cohesive silicone gel meaning that the gel maintains its shape like “gummy bear” candy or jello with more anti-leak properties unlike the gel prior to 2006 which was more like honey or molasses in consistency. These materials impact the feel and look of a breast implant, and thus are an important consideration in determining the desired appearance of your breasts.

For example, silicone is most popular world-wide as their feel and appearance most closely mimics the desired breast feel with less rippling. Standard saline implants have a higher rate of becoming hard (capsular contracture) and tend to exhibit more waviness or rippling if there is less breast or fat covering the implant. A newer breast FDA approved saline implant, IDEAL Implant^®^, is a double lumen “hybrid” implant that has the feel close to silicone, less risk of capsular contracture, and the peace of mind of saline; that is, if there is a leak, you can tell, just by looking in the mirror rather than requiring a MRI.

What results can I expect form breast augmentation?

According to studies, more than 90% of women are satisfied with the results of a breast augmentation. This is largely because the procedure often improves a woman’s self-esteem, not to mention quality of life. We aim to custom-tailor your breast augmentation based on your preferences for perkiness, firmness, shape, and size. Our goal is to match the appropriate implant type with the right procedure so that patients with realistic expectations are completely satisfied.

Breast augmentation will enhance the shape of your breasts as well as make them fuller. You may find yourself more comfortable wearing different types of clothing and may enjoy a boost in self-confidence, as is the case with most of my patients.

Usually, you can expect your breast augmentation surgery to have long-lasting effects, unless implant deflation requires surgical replacement with a new implant. Nonetheless, the effects of aging and gravity will eventually alter the shape and size of a woman’s breasts over time. As a result, you may later elect to undergo a breast “lifting” to restore the more youthful shape, size, and firmness. A breast lift of course can be performed at the same time as a breast augmentation or implant exchange.

Prospective patients should know that the final texture, shape, and appearance are not exactly the same as natural breasts. Many patients in fact prefer the firmness and slightly different contours than natural breasts. However, these differences may be more noticeable in some patients than others. The intended result of the procedure is to enhance the size and shape of the breasts to achieve the body image desired by the patient.

What are some considerations I should take into account when selecting a plastic surgeon?

The most popular way to improve breast size and shape is breast augmentation performed by experienced plastic surgeons. Generally speaking, seek out board-certified plastic surgeons by the American Board of Plastic Surgery with a great deal of experience and good reviews for best results. Those plastic surgeons that have specialized in breast and reconstructive surgery including breast revision surgery, such as the surgeons at Pacific Center for Plastic Surgery, are a great fit for your breast augmentation needs.

Larry S. Nichter, MD, MS, FACS

Breast Enhancement Options Following Pregnancy

Dr. Larry Nichter discusses the options available to women wanting to restore their breasts following pregnancy. In most cases, women experience a loss of volume in the upper portion of the breast along with some level of sagging. The severity of these issues will determine the recommended procedure. Options range from breast augmentation, breast lift with augmentation or a California breast lift, which is a lift in conjunction with fat transfer to the breasts.

New FDA Approved Silicone Natrelle 410 Breast Implants

The U.S. Food and Drug Administration has approved a new “gummy bear” silicone breast implant. The implants, whose official title is Natrelle 410 Highly Cohesive Anatomically Shaped Silicone-Gel Filled Breast Implants, are made by Allergan.

Image: FDA

The implants underwent seven years of research involving 941 women. The FDA’s conclusion from all this data is that the new silicone breast implants are safe and effective. The implants are now available for increasing breast size in women at least 22 years old, and for rebuilding breast tissue (reconstruction) in women of any age.

The approval comes with the condition that Allergan must continue post-approval research for five more years to ensure the safety and efficacy of the Natrelle 410 silicone breast implants. This does not mean that the safety of these implants is particularly in question, but rather reflects the high standards that medical devices of all kinds must meet to be approved in the United States.

The introduction of the Natrelle 410 silicone breast implant to the market is the most significant new approval since Sientra’s highly cohesive silicone gel implants last year. In the pipeline and hopefully soon to be FDA approved and released will be the innovative double-lumen saline Ideal Implant® with the feel of silicone but the safety of a saline implant. This alternative to traditional silicone breast implants is and will be available at the Pacific Center for Plastic Surgery.

Despite three decades of safety testing and monitoring of silicone breast implants, there is still a public perception that silicone breast implants are more toxic or dangerous than saline implants. The truth is that there has no known toxicity from silicone gel breast implants. In fact, silicone is one of the most common materials used in medical devices and implants. Read this article on the safety of silicone gel breast implants by Dr. Nichter for more information.

Dr. Larry Nichter is proud to offer the new Natrelle 410 silicone gel breast implant at the Pacific Center for Plastic Surgery. As board certified plastic surgeons with the highest qualifications, Dr. Nichter offers his patients the most advanced breast implants with confidence in their safety and performance.

Additional source: US FDA

Women’s Rights for Breast Reconstruction Following Mastectomy

The Federal Women’s Health and Cancer Rights Act of 1998 is still the law today.
Under the federal Women’s Health and Cancer Rights Act of 1998, a yearly notification
of your benefits pertaining to breast reconstruction must be sent to you by your insurance company.
The Women’s Health Care Act states that benefits must be provided for:
  • Reconstruction of a surgically removed breast
  • Surgery and reconstrcution of the other breast to produce a symmetrical appearance
  • Prostheses and treatment for physical complications from all stages of a mastectomy, including lymphedema
These benefits are subject to the conditions and terms of your plan, including maximum benefit amounts, deductibles, copayments, and coinsurance provisions. The benefits are subject to your plan’s exclusions and limitations.

IDEAL Structured Breast IMPLANT® feels more natural, new study finds

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.

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