nice article on augmentation and changes in silicone implants.....fyi

Breast augmentation was the most commonly performed cosmetic surgical procedure among women in 2008 with 355,671 undergoing the operation in that year (Source: American Society for Aesthetic Plastic Surgery).  Physicians of all specialties have a general knowledge of the storied history of breast implants in America, and this posting is to give those in the healthcare field an update on this very popular surgical procedure and medical device.

Problems with the earlier generation silicone gel implants were that they had a thick, unnaturally stiff shell, a high rate of gel bleed, and an unacceptably high incidence of capsular contracture (up to 70%). Third generation implants, from the mid-1980s forward until today, utilize a multi-layer barrier shell to decrease gel bleed and are filled with a thicker, more cohesive gel to reduce potential leakage. These implants, termed “responsive gels," have proven high rates of safety and efficacy, and were re-approved for general use with conditions by the United States FDA in November 2006. Currently, third generation silicone gel-filled breast implants are approved for: (1) reconstruction in women of any age and (2) augmentation in women 22 years or older. In contrast, saline-filled breast implants are approved for women 18 years or older. The two main implant manufacturers which provide plastic surgeons and patients with well-studied, safe FDA-approved breast implants for their patients in the United States are Mentor (Santa Barbara, CA) and Allergan Corporation (Irvine, CA).

As a female plastic surgeon, breast augmentation is my most requested and performed procedure. In Manhattan, my average patient is in her 20s or 30s, wants to do it for herself to improve the appearance of her breasts, may have one or two children, and has arrived at the decision to have it done independently and privately after conducting her own research.  I am using silicone breast implants about 85% of the time and saline implants about 15% of the time. I find that silicone implants more closely resemble the consistency and texture of normal breast tissue, and that the tactile and visual aesthetics are more pleasing. That being said, saline implants are still a nice option in women under 22 years of age for primary breast augmentation or when dealing with an asymmetry where it will be helpful to fill the implants different volumes intraoperatively. One of the benefits of saline-filled implants is that they can be adjusted in the operating room, as opposed to pre-filled silicone implants which often require the use of sizers intraoperatively for cases of different sized breasts. Patients should be aware that even a saline filled breast implant has a silicone polymer shell, and that the medical grade silicone used in breast implants is safe, chemically inert, and not linked to autoimmune disease or cancer.

In the following preop and postop example, the patient is 5′4″ and 115 pounds. I used 300cc smooth round moderate plus profile under the muscle saline filled implants.

(Left: Before, Right: After)

The breast pocket may be created in either the subglandular (under the gland) or subpectoral (under the pectoralis major muscle) space. The subglandular technique is usually reserved for patients who have substantial breast tissue or a mild degree of ptosis, or breast droop, since greater projection may be obtained. Also, women who are avid bodybuilders may prefer subglandular implants for the reason that placing them under the muscle in some instances may produce breast animation and distortions when the pectoral muscles are flexed. Increased risks of capsular contracture, rippling and implant palpability are typically issues discouraging the routine use of subglandular placement.

In the vast majority of patients, I believe the under the muscle technique produces optimum results. The pectoralis major drapes the top 3/4 of the implant, softening the transition, and therefore creating a more anatomically shaped breast mound. This method also achieves a natural feel, which is especially desirable when using saline implants. In addition to improved aesthetic outcomes, there are advantages in regard to breast-feeding as well as cancer screening.

The proper selection if breast implant size is extremely important for minimizing complications and optimizing patient satisfaction. I consider the base diameter of the chest, along with tissue laxity and the amount ofbreast tissue a patient is starting with, as the most important factors in choosing implant size. Implants come in three types of profiles: moderate, moderate plus or midrange depending upon the implant manufacturer, or high profile. For a given width, or base diameter, of an implant the implant project lower or higher on the chest.Implants that are too big for a woman’s individual chest dimensions lead to a higher likelihood of irreparable tissue stretch, bottoming out, and complications that may lead to reoperation.  Decreasing reoperation rates with breast augmentation is of national interest for many plastic surgeons.

In the following preop and postop example, the patient is 5′4″ and 115 pounds. I used 350cc smooth round high profile under the muscle silicone gel implants. This is a patient who has had children and breast-fed, leading to post-partum skin laxity and parenchymal involution.

(Left: Before, Right: After)

What’s New? Evaluation of the highly-cohesive, form-stable fourth generation implants is well underway by the FDA in the United States, but these implants have been widely used since the mid-1990s in many other countries and are very popular in Europe. These teardrop-shaped (often called anatomic or “gummy bear") implants are textured and contain a highly cross-linked form of silicone gel to minimize the possibility of silicone migration, as well as upper pole collapse and folds in the implant shell. Studies of these devices have shown significant promise in clinical trials with low rates of capsular contracture and rupture, and high rates of patient satisfaction. Both Mentor and Allergan Corporation have shaped anatomic gel implants that are being reviewed by the FDA but are available in Europe and other countries around the world. There are a matrix of different implants to chose from in these lines, with varying width, height, and projection for different body and breast types.

Allergan’s highly cohesive, shaped implant is called the Style 410, and the company is currently in discussions with the FDA and look forward to a decision regarding its approval, but cannot speculate on timing. A very similar situation exists with Mentor Corporation as well for their form stable shaped implant called Contour Profile Gel (CPG). The shaped cohesive gel implant represents a new option in the United States for women considering breast surgery for reconstruction and augmentation. In my opinion, the potential drawbacks are that they do feel a little firmer than the smooth round responsive gels, and the possibility exists that they could shift or turn in the pocket and not look or feel right if that were to happen (called malrotation). For this reason, very precise breast pocket dissection is needed for this type of implant. These implants do cost significantly more than saline, and likely will cost several hundred dollars more per pair than responsive silicone gel implants if and when they are approved by the FDA.

Since highly cohesive gel implants are not deformable, they cannot be squeezed through little incisions. Depending upon the size of the implant, incision length must be between 4.5-5.5 cm. It also can make insertion from around the areola difficult. Armpit, or transaxillary incision is possible, but exceedingly difficult. The reason at this point in time that I actually prefer smooth round gels is that they act and feel very much like normal breast tissue — when you lay down, normal breast tissue flattens and lateralizes, and so do the smooth round responsive gels. When you stand up, gravity takes effect and the gel situates within the implant at the base of the breast to give fullness in the lower pole and a smooth slope at the top. This can be illustrated in Figure 1a (Style 410) and Figure 1b (Smooth round responsive gel) with my nurse and the two types of implants in the photos. In addition, I also am able to fit smooth round silicone gel implants through relatively small incisions at the inframammery crease, areolar border (periareolar), or armpit.

(Left: Figure 1a, Right: Figure 1b)

In summary, pending FDA approval Mentor’s Contour Profile Gel and Allergan’s Style 410 will be the latest additions to the already wide selection of available implants; there are hundreds of breast implant combinations from type of filler, volume, base width and profile—all to help women and their surgeon find the fit that is appropriate for them.

The Future. Breast enhancement using fat grafts (lipoaugmentation) rather than silicone or saline implants employs fat suctioned from the patient’s buttocks, thighs or other fatty areas. This type of breast surgery can be used to increase the size of the breast or to fill in defects or abnormalities in existing breasts, including enhancing the appearance after breast reconstruction and softening the look of existing implants. Fat injections of the breasts may offer patients augmentation with a natural look and feel and the benefit of body contouring through liposuction—without the requirement for incisions or implants.

However, long-term safety and efficacy data as well as the effect of the procedure on breast cancer screening using mammography is still being evaluated in clinical studies. Concerns about fat grafting for breast enhancement include unpredictable or low survival rates of the transferred cells (which are frequently absorbed by the body), development of cysts, calcification and tissue scarring. Another major concern is long-term problems with breast cancer detection due to difficulties in telling the difference on mammograms between calcifications associated with breast cancer and calcifications associated with fat transfer.

This procedure does offer a modest opportunity for enhancement— specifically, about one cup size increase and the degree of enlargement will depend on the amount of spare fat that the patient has. But, numerous questions remain about this new technique: How much of the fat survives? Does the procedure have to be repeated? Are the breasts hard and uncomfortable for long periods after the procedure? And most importantly, what are the cancer implications of this technique? Research projects, funded by the Aesthetic Surgery Education and Research Foundation (ASERF) of the American Society for Aesthetic Plastic Surgery are being conducted to determine the safety and efficacy of breast enhancement with fat.

In the meantime, plastic surgeons will continue to study the intricate details of the procedure for the safety of our patients– namely, the techniques of harvesting, preparation, and placement of the fat tissue, who should receive fat transfer, when it is appropriate, and whether it is safe for the long term.  This procedure istechnique dependant and to avoid complications it must to be done correctly by a properly trained, board-certified plastic surgeon.

Let the Buyer Beware. Have you heard of dermal fillers? These materials are gel-like compounds that can be injected into the body and have been traditionally used in facial rejuvenation. They increase the volume of the area injected, and are either classified as permanent or semi-permanent. Restylane, Hylaform, and Juvederm are types of hyaluronic acid dermal fillers that are currently FDA approved for injection into the nasolabial folds, or laugh lines, of the face.

Swedish scientists have developed a dermal filler called Macrolane (made by Q-Med in Sweden) which is being marketed in Europe and is not approved by the FDA for use in the United States. Macrolane is composed of hyaluronic acid but in larger particles than those found in Restylane. This makes it more suitable for treatment of larger areas, and the body may absorb it more slowly given the larger particle size. Known on the internet and in the media as a “Boob Jab," Macrolane is being touted for breast augmentation and shaping of the décolletage, as well as an adjunct after breast implant procedures and liposuction when there may be contour problems. Compared with treatment with Restylane, much greater volumes are used in an average treatment with Macrolane and the gel is injected deeper in the skin layer to add larger volumes.

But be aware that this procedure is not permanent - all dermal fillers are eventually absorbed and metabolized by the body! One round of Macrolane breast augmentation may last 1-2 years, but could resorb in less time than that. Controversy exists around this procedure as we don’t know exactly how this material will look on mammogram, if it will eventually cause permanent lumps and bumps, or if it could even obscure of confuse the diagnosis of a future breast cancer.

My associate recently met a woman from London who consulted with him about getting silicone breast implants. The patient reported that she had undergone breast injections with Macrolane for enhancement. The procedure was done by injecting the material through a cannula, or hollow tube, with incisions of 6-7mm on either sides of her breasts. The patient stated that the material was injected under the pectoralis major muscle and was indeed painful even though some local anesthesia was used. She went from a full A cup to a B cup…but all of the material was gone in 2 ½ to 3 months, and then she was right back down to an A-cup! Hence the consultation for real breast implants.

Other drawbacks of the “Boob Jab" procedure include that Macrolane is only available in the UK and Europe, costs an average $4,000 - $7,000 (similar to the cost of breast implants, which is a much longer lasting form of enhancement!), and we don’t know its long term effects on breast tissue and the overlying skin. This means the procedure and payment needs to be repeated every 1-2 years if you decide to enter into such a treatment plan.

Can breast pumps be used for breast enlargement and how do they work? Breast pumps basically work through the physiological process known as tissue expansion. If you apply a gentle pressure to stretch skin or other soft tissues, they slowly stretch. If you’ve ever seen a person with oversized ear plugs or a native tribesman with a large ornament in his lip, you’ve seen tissue expansion at work. By applying relatively gentle vacuum (negative) pressure to the breasts, breast pumps encourage the process of tissue expansion. Over time this leads to a modest increase in breast size, but temporary breast pumps in my opinion are really not a viable permanent breast enlargement solution. In fact, overuse of this type of breast pump may cause broken blood vessels, skin irritation, and discomfort. The Brava system (Brava, LLC, Coconut Grove, FL) is one of the more popular branded devices for external breast enlargement by this method that has been studied in a well-controlled fashion. The Brava system has been shown to increase breast size after prolonged use, but there are some significant drawbacks including the following:

• Cost - the Brava device runs about $2500

• Time - the device must be worn 10 hours a day for 10 weeks, or 700 hours

• Discomfort - the device applies a rather strong suction to the chest, which many women find uncomfortable

• Amount of growth - on average, after 10 weeks, a woman may gain about 100 cc of breast volume, and that’s only about ½ of a cup size.

• Embarrassment - you don’t want to be seen outside the house in this contraption, and most women would not be game for wearing this apparatus on their breasts for 10 hours a day… it’s simply not feasible.

In conclusion, breast augmentation is a commonly performed procedure in plastic and reconstructive surgery, and all physicians who have female patients should have a general working knowledge of the types of implants and procedures that are out there today to properly counsel and/or refer their patients if asked about the topic.  Do you think breast implants will ever become a thing of the past with fat transfer and stem cell therapy in the horizon?