In November 2006, the FDA allowed silicone impants back on the market. In June 2011, the FDA released a follow-up statement on the clinical and scientific information for the use of silicone gel-filled implants. This report reiterates the safety of silicone implants for breast augmentation and breast reconstruction.

A brief summary of the FDA’s findings:

. When used as labeled, silicone implants are reasonably safe and effective.

. No association is evident between silicone implants and connective tissue disease, breast cancer or reproductive problems.

. Breast implants are not a permanent lifetime device and will have to be replaced. “Between 20 to 40 percent of augmentation patients and 40 to 70 percent of reconstructive patients had reoperations during the first 8 to 10 years after they received their implants”.

. An MRI is recommended for detecting silicone implant ruptures.

http://www.fda.gov/d … plants/UCM260090.pdf

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Recently we have seen several women in our practice with ruptured breast implants. If you are considering breast augmentation (enlargement) surgery it is important to understand that your implants might need to be replaced in your lifetime.

Allergan and Mentor, supply 99% of the implants used in the United States, offer free lifetime replacement on their failed devices. The companies do not cover all the other incidental costs of replacing your implant.

Below is the summation of the warranties-

.automatic enrollment at the time of your surgery
.lifetime product replacement
.silicone and saline implants are both covered
.during the 1st 10 years financial assistance of up to $1,200 for out- of -pocket expenses
.optional warranty plans are available for a fee through each implant company

To see the full warranty click on the links below.

http://www.mentorww … antyInformation.aspx
http://www.cppwarranty.com/

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A recent study in the April issue of Plastic and Reconstructive Surgery, the journal of the American Society of Plastic Surgeons raised concerns regarding breast augmentation with fat injections.
The concern involves microcalcifications which developed as a result of fat necrosis ( some of fat cells not surviving and appearing as microcalcifications on mammograms). These microcalcification are usually looked for on the mammogram to detect breast cancer and therefore may cause some confusion in patients who have undergone fat injections and developed microcalcifications as a result of the procedure. A previous study in the March issue of PRS, however , concluded that fat grafting was not problematic.

There has been much debate regarding the use of fat grafting for breast augmentation. The ASPS noted the difficulties with early diagnosis of breast cancer in the 1980s. Other recent studies have had more favorable results and have been able to distinguish between microcalcifications after fat injections and those associated with breast cancer on mammogram.

Fat injections for breast augmentation remain an area of intense interest, debate, and ongoing research and presently may be regarded as somewhat controversial.
For more information see;
http://www.plasticsu … n-on-Mammograms.html

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One of the most common reasons for re-operation after breast augmentation is for purposes of size change–usually to become larger. At the Baystate Center for Plastic Surgery, Dr. Delia takes every effort to avoid this additional surgical procedure by actively involving patients in the decision-making process. During the initial consultation, patients goals are discussed, measurements are taken, and patients examined. A fitting bra may then be used with a variety of breast implant sizers until the desired shape and size is achieved. A second visit is then scheduled giving the patient time to think about her choice and the sizing process is again repeated. A discussion ensues regarding anatomical concerns Dr. Delia then discusses anatomical concerns which are unique to each patient and advises regarding concerns about type of implant implant(silicone vs. saline), the choice of shape for the implant(round vs. teardrop), and other technical problems are all addressed. After the second consultation for breast enhancement surgery, most patients feel comfortable with their choices and have narrowed down the size of the implant they prefer (to within 25 cc or so which typically represents only a small fraction of a cup size). However, if there is still a concern, some patients will be asked to schedule another visit to finalize the most appropriate options for their breast enlargement surgery.

At Bay State Center for Plastic Surgery, we never pressure patients into making quick decisions. We want happy, satisfied patients. We engage them in the process and have them actively participate in breast implant selection. We also make sure the patient understands any concerns the surgeon may have regarding their choice. With this approach, we find patient satisfaction to be very high and re-operations for breast augmentation surgery are kept to a minimum

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A recent clinical study compared levels of patient satisfaction regarding the choice of silicone vs. saline breast implants after postmastectomy breast reconstruction. The results of this study revealed a higher level of satisfaction in those patients who chose silicone implants. In fact, the study statistically indicated a significantly higher overall satisfaction with their breast reconstructions. In addition, the patients who chose silicone implants indicated improved psychological well-being and a greater sense of physical and sexual self-esteem.

The choice, however, is not always an easy one for women. This may in part be due to the media’s past portrayal of alleged silicone-related complications and the resultant public perception. Yet, after thorough review of current medical literature on the subject and the fact that the F.D.A. has once again deemed the use of silicone in breast implants safe, many women do opt for silicone implants in their post-mastectomy reconstructive surgeries as well as for cosmetic breast augmentation. Considering the results in the previously mentioned study, these women are apparently very satisfied with their outcomes and the choice they made.

Stephen Delia, M.D.

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