Two-Year Results for New Saline Breast Implant: the IDEAL Implant

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.

Abstract

Click on the thumbnail to download this article in PDF format.

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

New Sientra Breast Implants in Newport Beach

Breast implant manufacturer makes finding a highly qualified plastic surgeon easier by only selling its implants to board certified plastic surgeons.

Dr. HorowitzChoosing a plastic surgeon who is certified by the American Board of Plastic Surgery is an important step in getting the best breast augmentation result you can.

A new silicone gel breast implant by Sientra will making finding a highly qualified surgeon even easier; its new implants will only be distributed to plastic surgeons who are Board Certified.

The release of the new silicone gel breast implant was announced at the last meeting of the American Society of Plastic Surgeons in Vancouver.

Sientra is not a new company, but it is a new competitor with Allergan and Mentor in the breast implant market. Allergan and Mentor continue to sell breast implants to doctors of any specialty, including ear-nose-throat specialists, OB-GYNs, family practitioners, and general surgeons.

By contrast, Sientra will pre-screen the surgeons whom it allows to use their breast implants. By excluding doctors who are not plastic surgeons, and plastic surgeons who are not board certified, Sientra ensures that patients who receive their implants will be in the care of highly skilled and educated plastic surgeons.

This exclusivity has been implemented as part of a commitment to the safety of patients and the quality of aesthetic plastic surgery.

Sientra also offers what is currently the best breast implant warranty available: an automatic lifetime warranty plus $3,600 toward surgery and anesthesia.

Dr. Jed Horowitz, MD, FACS is a board certified plastic surgeon in Newport Beach and Huntington Beach. He looks forward to offering the new Sientra implants to his patients, which are extremely cohesive, similar to “Gummy Bear” implants. Not only are the implants of excellent quality, but the fact that Dr. Horowitz is approved to offer them corroborates his skill, qualifications, and excellence as a plastic surgeon.

LiteLift™ – The New Facelift

The ‘O.C.’ Lifestyle — Better than Beverly Hills

Dr. Horowitz

Dr. Horowitz

The Lite-Lift is a modified facelift that can be performed in our office under local anesthetic in just two hours. Compared with a traditional facelift, the incisions are smaller, procedure less invasive, and best of all, natural with much quicker healing. The older ‘mini facelifts’ only lifted the skin; the Lite-Lift tightens the underlying structures, with better, longer lasting results.

Beverly Hills has long been known for its high profile plastic surgeons as popularized on TV shows such as Doctor 90210, and nip/Tuck, but the OC (Orange County) has more board certified plastic surgeons than any area in the United States. Dr. Jed Horowitz and Dr. Larry Nichter, two of the plastic surgeons of Orange County, have more than 25 years experience in performing cosmetic facial surgery. Their office, their staff and their personal experience with facelifts, body contouring and breast surgery rival the best of the best of Beverly Hills, Hollywood, West Los Angeles and Santa Monica, Like Beverly Hills, patients having facelifts in Orange County want the most sophisticated techniques that look natural and heal quickly. The Lite-Lift is the facelift for celebrities, business people and the housewives of Orange County.

All board certified plastic surgeons are trained to perform traditional facelifts that have provided consistent results. Most doctors are reluctant to change the techniques that have given them satisfactory outcomes. The Lite-Lift requires time to learn and develop the expertise our patients deserve. An ‘expert plastic surgeon’ as defined in a recent article by Dr. Rod Rohrich, editor of Plastic and Reconstructive Surgery Journal, is “a person with special knowledge… the time, ability and dedication to focus on excellence.”

By this definition, Dr. Horowitz and Dr. Nichter are the ultimate experts in the field of Cosmetic Facial Plastic Surgery, having refined their skills for years to offer the best for their patients. They don’t just rely on the title of being a ‘Beverly Hills Plastic Surgeon,.’ But rather they rely on their training, years of experience and passion for innovation and excellence.

The Lite-Lift Facelift is one of the more progressive treatments performed by only a limited number of Board Certified Plastic Surgeons. The best candidate is a man or woman who has early changes in their skin, neck and jowls. That being said, we have performed the Lite-Lift under local on patients even in their 70’s. In the past, I would have only recommended a traditional facelift for mny of these men and women. They have all been very excited with their Lite-Lift results, and I myself have been amazed at what great outcomes these patients have experienced.

—Jed Horowitz, MD, FACS

The Importance of Compression Garments after Liposuction

Dr. Larry Nichter

A compression garment is required and beneficial after liposuction because:

  1. It restricts the amount of edema that forms and hastens its resolution by mechanical pressure.
  2. It decreases the amount of bruising.
  3. It assists the loose skin in retracting or shrinking.

It is common to have weight gain due to edema, serum that collects in the area, and the tumescent fluid that was injected. This will resolve over time. The more you wear the garment initially, the quicker this fluid resolves.

Edema: a condition characterized by an excess of watery fluid collecting in the cavities or tissues of the body.

The length of time that the garment should be worn varies depending on the amount of fat removed, the elastic nature of your skin, how much loose skin remains, and other factors. Your surgeon would give you the best advice, however this is the general routine for my patients.

The first garment should be fitted for you in the office prior to surgery and applied in the operating room. Often it will become loose as the edema is mobilized, and then it will need to be replaced. Spanx is a reasonable compression garment if it gives enough support and is the right size. I have my patents bring them in so I can confirm that it fits well.

Most important advice is to listen to your surgeon, as he or she knows how much fat was removed, the elasticity that remains in your skin, and amount of skin redundancy.

I recommend that my patients wear their garments for a minimum of three weeks full time then for twelve hours at a time (day or night). If there is not a lot of redundant skin, this continues to a maximum of six weeks.

To be effective, the garment needs to fit snugly—but not too tight as that can make it difficult to sleep or cause pressure problems (inspect your skin when it is exposed if you are uncomfortable). As the edema resolves it is common for patients to switch to a smaller garment that fits. A Spanx-type garment would work fine, rather than ordering one or paying more at your doctor’s office.

—Dr. Larry Nichter, MD, FACS

Information About Post Operative Nausea and Vomiting (PONV)

Post operative nausea and vomiting (PONV) is a serious problem for patients who are undergoing elective surgery. For facial aesthetic surgery PONV can lead to hematoma, delayed healing times, and other complications not the least of which is patient suffering.

Our focused interest in this problem was motivated by the progressive increase of PONV despite liberal use of antiemetics such as Odansetron (Zofran). At the same time we noted the increasing prevalence of antidepressant medications taken by our patients.

Based on our experience and extensive review of the literature we have established a perioperative treatment protocol that is beneficial to your patients and their well being.

Dr. Nichter

Dr. Nichter

Dr. Horowitz

Dr. Horowitz

Serotonin Syndrome is a poorly recognized but potentially dangerous condition which in its early stages may include nausea and vomiting (PONV) , hypertension, fever, tachycardia, agitation, restlessness, insomnia, mental status changes, diarrhea, etc. All of these are dangerous in the post operative healing period.

Serotonin Syndrome occurs when two or more drugs are taken together and cause too much available serotonin. Antidepressants (including selective serotonin reuptake inhibitors (SSRI), selective serotonin/norepinephrine reuptake inhibitors (SSNRI), and monamine oxidase inhibitors (MAOI); Migriane Triptan medications including Imitrex, Relpax and others. Pain medications: (especially Tramadol), opioids; antiemetics such as odansetron (Zofran); and even cough medicines with dextromethorphan have been implicated in Serotonin Syndrome.

When your patients, who have been appropriately prescribed these medications, are then given certain pain medications or antiemetics they may develop serotonin syndrome and PONV.

We are attaching a table listing some of the multiple drug classes that have been implicated in this syndrome. In order to keep Serotonin Syndrome from occurring in our patients, we use the protocol attached. This includes the use of Cyproheptadine (periactin) as prophylactic when serotonin medications are used.

We your taking note of these guidelines during the postoperative period and contact us directly if you have any concerns or suggestions.

Thank you for reading.

Best wishes,

Larry S. Nichter, MD, MS, FACS — Jed H. Horowitz, MD, FACS

The California Breast Lift®

Dr. NichterWant 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 and Dr. Horowitz have 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 and Dr. Horowitz use their 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 and Dr. Horowitz call our office number: (714) 902-1100 or go to our web site: PacificCenterForPlasticSurgery.com.

Related pages:

Advances in Minimal Scar Facelift Surgery: The Lite Lift™

Dr. NichterMinimally invasive procedures are the focus of all surgical fields and plastic surgery is no exception. The trend for looking your best has moved towards procedures that have rapid healing times, reduced risk and leave significantly less scarring than traditional methods. More importantly, most patients want a natural, refreshed look without the appearance of having had surgery. The Lite-Lift™, modified facelift procedure, exemplifies these principles by having 40% less scarring, and nearly half the surgical down time. Rather than being performed with general anesthesia, most are performed in our office with oral sedation and local anesthesia without an IV. Dr. Nichter and Dr. Horowitz are experts in this technique and are able to tailor your rejuvenation to better achieve the patient’s desired results.

It seems rational that the more extensive a procedure is, the more dramatic and long lasting the outcome will be but this is not always true. Though there is still a place for the traditional facelift, with it there is also increased recovery time and potential for problems. By using advanced techniques deep to the skin, we are able to minimize external skin incisions and scarring. For example, placing the scar within portions of the ear and ending the incision behind the earlobe crease eliminates the usual telltale scar of a full facelift. Similarly, repositioning the incisions to hide them is also used. For example, beveling the incisions just behind the hairline allows the sideburn not to be displaced too high while allowing hair to grow through the scar to conceal it. In contrast to the traditional facelift, the Lite-Lift™ re-draping of skin is upward, a more natural, antigravity, direction eliminating the “swept away” unnatural pull too often seen in Hollywood stars with older facelift techniques. These and other advanced techniques along with modifications and innovations by Dr. Nichter and Dr Horowitz are what make up the essence of the Lite Lift™.

The techniques of the Lite Lift are advanced and predictable in the most skilled hands of Plastic Surgeons Board Certified by the American Board of Plastic Surgery of which Dr. Nichter and Dr. Horowitz are members. The best candidates are those patients with some remaining skin elasticity but this technique is also applicable to most patients including those in good health but advanced age. Best of all, this technique can incorporate synergistic procedures such as blepharoplasty (eyelid lift), temple/brow lift, cheek lift, and liposuction of the neck and jaw line, chemical peels and more. These added procedures heal simultaneously so a speedy recovery is expected.

Our patients remain our biggest source of our referrals. Over time they remain thrilled with their Lite-Lift™ results. I share their enthusiasm and appreciate their long lasting rejuvenation which affects them inside and out.

—Larry S. Nichter, MD, MS, FACS

For more information about the Lite-Lift™ or other cosmetic procedures performed by Dr Nichter and Dr. Horowitz call our office number: (714) 902 1100 or visit our dedicated website: LiteLiftDr.com.

Child scarred in fire at home, recovers use of hand after surgery

Larry S. Nichter, M.D., F.A.C.S. and Jed H. Horowitz, M.D., F.A.C.S.

Homero Tseremp is 3 years old. He lives in the jungle with his family.

When he was 4 months old, Homero was alone when a fire broke out. Homero’s right hand and wrist are contracted due to burn scars. Homero underwent surgery on Nov. 19 and had his burn contracture corrected by Dr. Nichter.

Homero’s burn injury resulted in the loss of his little finger, and his hand was bent at a 45-degree angle. His ring finger and the remaining small pieces of bone from his little finger had fused into his forearm. He was unable to bend his wrist or use his hand.

DR. NICHTER was able to straighten Homero’s arm and save his fingers during corrective surgery. Homero will have the use of his arm and hand.

BEWARE of Unsafe Standards for Liposculpture or Liposuction!

Larry S. Nichter, M.D., F.A.C.S. and Jed H. Horowitz, M.D., F.A.C.S.

Recent advertisements in the Los Angeles and Orange County area have promoted a doctor who clearly states that he is not a “Board Certified Plastic Surgeon” and then goes on trying to convince his audience that he only does minimally invasive procedures to remove fat, not invasive “surgery” like real plastic surgeons. He states that you can even “drive home” yourself after your procedure.

It is unfortunate that the public still does not understand what is safe when it comes to Plastic Surgery!!!!

Any procedure that removes 1-10 lbs of fat IS INVASIVE by definition. The video on this doctor’s website should create a field day for our plaintiff attorney friends as several standards of practice in the performance of liposuction are severely questionable. Sterile technique, the location of surgery, and post operative care are all in question.

Who is liable for the patient who passes out in their car on the way home and crashes after having 5 liters of fat, fluid and blood removed. Is driving home after what is truly an invasive procedure in anyones best interest? Is this something that a reasonable surgeon in California should advocate?