IDEAL Structured Breast IMPLANT®: 2-year Follow-up Study Results

Larry S. Nichter, MD; and Robert S. Hamas, MD

“Two-Year Outcomes With a Novel, Double-Lumen, Saline-Filled Breast Implant”
Originally published by the American Society for Aesthetic Plastic Surgery, Inc.

Click on the thumbnail to download this article as a PDF.

Abstract

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.2-5 Continue reading “IDEAL Structured Breast IMPLANT®: 2-year Follow-up Study Results”

IDEAL Structured Breast IMPLANT® Q&A

Dr. Larry Nichter

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?

Yes

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.

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IDEAL Structured Breast IMPLANT® Trials Promising

With the Ideal Implant, women will no longer have to choose between peace of mind and a great result when it comes to breast augmentation. Dr. Larry Nichter explains.

Saline and Silicone, Safety and Performance

Dr. Larry Nichter

Women have so far had essentially just two breast implant fill choices: saline or silicone.

Silicone implants have distinct advantages over saline implants in terms of performance: they wrinkle less and conform to a more natural breast shape, and also have a softer feel that is more breast-like. However, silicone implants have gained a reputation—possibly undeserved—for being less safe than saline implants. Despite the fact that there is no known  toxicity of silicone gel breast implants, the possibility of a “silent rupture,” undetectable except by MRI, has been enough to make many women opt for saline implants or wait for a better product to come along. The time will be here most likely within a year or so with the advent of the Ideal Implant, the name given to a new design saline hybrid implant. It has the natural feel of silicone and safety of saline.

Saline implants, though providing peace of mind by being perceived as safer than silicone, often do not create a result that seems as natural. Wrinkling, scalloping, a globular shape, and water balloon-like feel, and increased risk of capsular contracture have been the trade-off for peace of mind with breast implants. The Ideal Implant solves many if not all of these concerns.

The Ideal Implant has both

The Ideal Implant is one of the major technological advances to come along in the past few decades in implant manufacture. Using a novel design with internal baffles, the saline implant is manufactured to achieve a similar feel and performance comparable to a silicone implant. Approximately 95% of both patients and their surgeons expressed satisfaction at the current two-year data point by the FDA. The Ideal Breast Implant is soon to be released in the US market, hopefully with in the year.

Image: idealimplant.com

As one of the lead FDA study investigators, I have personally followed my Ideal Implant patients for more than two years. The vast majority of my patients are thrilled with the results. My follow up exams indicate that in most cases they have the feel more like silicone than saline.

When placed on a convex surface similar to the curve of the chest wall, the Ideal Implant conforms to a more natural breast shape; its edge lies lower and its outward surface does not collapse. This is because engineers designed the Ideal Implant with three nested baffle shells, which are unattached and perforated. This makes the saline move slowly between the compartments, giving it gel-like characteristics and a feel more like that of a natural breast.

The Ideal breast implant uses no new materials or manufacturing processes—only tried and tested ones—and is made completely in the United States. The manufacturing process is automated to ensure uniform thickness of the membrane shell, unlike the hand-dipped ones that are used for breast implant manufacturers by other companies. Perhaps most important, the President of the Company, Dr. Robert Hamas, indicated that this implant will only be made available to board certified plastic surgeons by the American Board of Plastic Surgery. To date, the other saline breast implant companies in the US, Allergan and Mentor, sell their product essentially to any MD or DO whether they are a plastic surgeon or not, and even to non-surgeons without board certification. This gives an added advantage to the consumer knowing that when they have an Ideal breast implant placed it will be done by someone well trained and competent—by a board certified plastic surgeon.

The Ideal breast implant is currently undergoing FDA trial studies in 502 women, the second-year results were recently released and are very promising. The capsular contracture rate, for example, at the two-year follow up mark of the current FDA study indicates a dramatic decrease of capsular contracture. To date, the Ideal breast implants show significantly lower rates of capsule contracture and wrinkling, as well as high patient satisfaction. Deflations from early manufacturing defects were identified and addressed, and manufacturing processes have been refined.

Though it has yet to be released to the general public, the Ideal Implant is shaping up to be a contender in the open market with traditional saline and silicone implants.

—Dr. Larry Nichter, MD, FACS

Additional Source: The Ideal Implant website

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.

[si-contact-form form=’2′]

New Breast Implant on U.S. Market

Dr. Larry Nichter of the Pacific Center for Plastic Surgery would like to make prospective breast augmentation patients aware that the FDA has approved a new silicone gel-filled breast implant made by Sientra, Inc. for use in the United States.

The implants will be available for women at least 22 years old seeking augmentation surgery, and women of any age seeking breast reconstruction surgery.

Silicone gel-filled breast implants are medical devices implanted under the breast tissue or under the chest muscle for breast augmentation or reconstruction. These implants have a silicone outer shell that is filled with silicone gel. They come in different sizes and have either smooth or textured shells.

This approval introduces a third company into the U.S. breast implant market, which previously consisted only of Allergan and Mentor.

The deputy director for for science at the FDA’s Center for Devices and Radiological Health, Dr. William Maisel, commented that although silicone gel-filled breast implants have demonstrated consistent safety, “It’s important to remember that breast implants are not lifetime devices. Women should fully understand risks associated with breast implants before considering augmentation or reconstruction surgery, and recognize that long-term monitoring is essential.”

The approval of these new implants follows a 3-year study involving clinical trials of the implants on 1,788 women.

As a condition of the approval, Sientra will carry out five- and ten-year studies into the long-term health effects of their implants.

Source: FDA – FDA approves new silicone gel-filled breast implant

The California Breast Lift®

Dr. Larry Nichter

Want to enlarge or improve your breasts with your own fat?

For years, Plastic Surgeons and their patients have desired to transfer unwanted fat from their tummy or thighs to their breasts. We are now are able to do this safely.

If you have been considering a Breast Lift or improving your appearance after breast augmentation or Breast Reconstruction but are not comfortable with introducing artificial material into your body, you may want to look into the benefits of breast augmentation with fat transfer. An alternative to breast implants is fat transfer also known as fat grafting or lipoinjection. This technique allows women the option of enhancing the appearance of their breasts without the potential problems of saline or silicone implants such as hardness, rippling or rupture.

Who is a candidate?

  • Any woman who is healthy
  • Women with sufficient body fat for the procedure
  • Women considering breast augmentation who wish to be one cup size larger or less
  • Women who have had breast augmentation or reconstruction but who lack fullness or have contour concerns. Fat transfer can further enhance and reshape your breasts while smoothing out visible or palpable edges of breast implants. This will disguise implant rippling and wrinkling.
  • Women with normal mammography

Dr. Nichter has successfully transplanted fat into the face, buttocks and other body areas for decades and are now using this same technology to enhance breast shape and size. Plastic surgeons have been transplanting fat to the breast since 1995 but caution and study were necessary to make sure there were not harmful effects. Furthermore, results in the past were variable, dependent on surgical equipment, technique, surgeon’s skill, and individual patients healing abilities.

Since 1995, recent advances have led to the development of special instruments made just for fat grafting. Dr Nichter uses his decades of experience and advanced knowledge of this technique to transfer body fat from other unwanted areas to the breasts. Though this procedure is still considered investigational to a degree, more and more qualified plastic surgeons are using this technique successfully.   The advantage of this technique is its ability to create a natural augmentation without an implant. Fat grafting (also called lipoinjection or fat transfer) to the breasts is indicated for different reasons: as an alternative to implants for mild to moderate breast augmentations, to provide fullness to the upper part of the breast during a breast lift, after pregnancy, age, or weight loss, following breast reconstruction, or to minimize the visibility or rippling of existing breast implants. Typically up to one breast size enlargement is possible in most patients. Fat transfer to the breast is usually done as a single procedure resulting in approximately half a cup volume increase. In women desiring additional breast enhancement a subsequent procedure can be performed. Each surgery consists of two components:

  1. Harvesting the fat: Fat is removed from your abdomen, hips, “love handles” or other areas using a fine cannula similar to the one used for liposuction but skinnier. This fat is rinsed with sterile saline solution and then packaged into syringes and prepared for transfer. Approximately 20% of fat removed is suitable and available for fat grafting.
  2. Fat transfer into the breasts: The prepared fat is injected in small amounts at a time and widely distributed within the layers of the breast so that these living fat cells can pick up a healthy new blood supply.

Advantages of Fat Transfer to the breasts:

  • Fat cells are natural and you are using your own tissue without any foreign body or implant.
  • Harvesting of the fat by liposuction has the added benefit to enhance your shape by removing unwanted fatty deposits
  • The breast can be shaped or sculpted in more detail than is possible using implants alone.
  • Minimal incisions reduce the possibility and degree of scarring
  • No implant is used, therefore there is never a need for replacement, or any potential for capsular contracture (hardening of the implant).
  • Fast Recovery Time: Recovery time is about 1 week and usually less uncomfortable from implants that are placed beneath the muscle.

Although, breast augmentation performed with the lipoinjection technique takes longer than traditional breast augmentation (with implants) the benefits are substantial including no need for implant replacement in the future.

In the past, significant questions were raised about the ability of Mammograms or MRI to detect breast cancer after injecting fat into the breast. However, there is no evidence that fat transfer to the breast is less safe than any breast surgery. Large studies have begun over the last several years to study fat grafting to the breast. With or without breast surgery, calcifications and lumps can occur. Breast diagnostic studies including physical examination and mammograms should be used to monitor every patient diligently using standard guidelines.

As a general rule, surgeons with extensive experience in grafting large volumes of fat to the body are most likely to obtain the best results. We believe fat transfer should only be performed by surgeons certified by the American Board of Plastic Surgery that have experience in  fat grafting. Few plastic surgeons have this experience. This ensures that your surgeon has advanced knowledge and technical familiarity, but also the subtle anatomy and aesthetics of breast augmentation.

Our patients remain the biggest source of our referrals. Over time they continue to remain thrilled with their results from these and similar procedures. I continue to share their enthusiasm and appreciate their long lasting rejuvenation which seems to affect them inside and out.

—Larry S. Nichter, MD, MS, FACS

For more information about the No Implant Breast Augmentation by fat grafting or other cosmetic procedures performed by Dr.  Nichter call our office number: (949) 720-3888.