Breast Implants
The Devices and the Choices
“The implant you choose is the implant you’ll live with—understand the tradeoffs of different implants, and choose carefully.”
Implant choices? There are many: round shape, anatomic shape, underfilled, adequately filled, overfilled, smooth outer shell, textured outer shell, saline filled, silicone gel filled, or filled with alternative fillers. Each of these choices is currently available somewhere, and each is a valid choice in certain situations. Each has benefits and trade-offs. How do you choose? Start by learning about the alternatives! This chapter contains a lot of information—maybe more than you think you would like to know! But the alternative—not knowing—could cost you significantly in the future. The only way to make the best decisions is to fully understand the many issues regarding implants.
You can’t know too much about implants—the issues and the choices.
Not knowing now could cost you significantly in the future—in quality of results and in complications and need for additional surgery.
The future price of poor decisions from lack of knowledge is too high for any patient to pay.
Breast Implants Are Devices...
A breast implant is a device. Can you name any device that’s perfect? Can you name any device that lasts forever? Can you name any sophisticated device that never requires maintenance? Probably not. So let’s start out with three basic truths:
Breast implants are not perfect.
Breast implants don’t last forever.
Breast implants may require some maintenance.
If you believe these three statements, you have taken a big step. If you accept that something’s not perfect, you can begin learning about its imperfections and whether you are willing to accept them. If you accept that something won’t last forever, you can begin to understand the factors that affect its longevity and make choices that help prolong its life. You can also decide whether you are willing to have maintenance if it becomes necessary.
If you can’t accept the imperfections of implants or if you are unwilling to have maintenance, don’t have a breast augmentation.
Implants: What Do I Need to Know?
This chapter is organized to meet the information needs of two different groups of women. If you want basic information about the currently available alternatives and don’t want to spend more time understanding all of the issues about implants, read the first half of the chapter. If you want more detailed information that focuses on the important issues that affect implant longevity and the trade-offs between naturalness and longevity, read the entire chapter. Many of the most important issues about breast implants are not addressed in any other written information for the public. Although some of these issues may seem too detailed, dry, or boring, they affect your long-term result, risk of reoperations in your future, and risks of complications and problems.
As a potential patient, you will almost certainly learn about what is “the latest,” what is “new,” and what is supposedly “best.” What you may not learn is that the first two of these (the latest and new) do not necessarily correlate with the last (what’s best). Before we discuss current implant alternatives, we will offer you some interesting and potentially valuable background information.
Regardless of how much you may want to know, you can benefit from knowing a few facts about the history of breast implants, why many “new” designs that receive a lot of marketing hype and press coverage seem to disappear, and patterns of marketing behavior that have become common in the breast implant industry. The following are three “lessons” that may provide valuable insight.
Lesson 1
When is “new” really new, and when are old products resurrected and recycled?
In the technology age, we all want what is “newest” and often equate what is “newest” to what may really be best. When it comes to breast implants, there are some important lessons here. Breast implant manufacturers recognize patients’ desire for “newer” implants, and if the manufacturers really don’t have anything that is truly “new” or really better, historically they have reinvented old designs, and recycled old implant designs under the guise of “new products.”
The most recent example of this recurring trend occurred in 2000–2001 when Mentor Corporation began heavily marketing their “new” round, high profile implants (implants that have more front-to-back or forward projection compared to lower profile implants). The novelty and effective marketing resulted in patients’ and surgeons’ believing the hype, when in reality there is absolutely nothing new about high profile implants. This type of implant has been available since the 1970s—over three decades!—yet many younger surgeons (and some not so young) as well as many patients who didn’t know the history fell prey to the marketing. What patients were told was that they could achieve a more “projecting” breast, and in some instances, they could. What many may not have been told is that high profile implants were largely discarded by some surgeons in the late 1970s (except for a few specific types of breasts) because they had all of the following potential trade-offs and potentially could cause all of the following tissue compromises:
- Pressure on overlying breast tissue, causing shrinkage or atrophy of existing breast tissue.
- For any given volume, more of that volume is placed in the lower breast, the area already most prone to stretching.
- Because the round, high profile implant has a narrower base (for a given volume) compared to lower profile implants, it will produce less upper breast fill (shorter vertical height).
- All current round, high profile implants collapse vertically when filled to a manufacturers’ recommended fill (varying amounts depending on patient tissue characteristics), further decreasing upper breast fill.
- To achieve adequate upper fill, a larger volume implant is required, adding more weight, more stretch, and all of the potential compromises of excessive stretch: tissue thinning, visible implant edges, traction rippling, etc.
- For any given volume, the base width of the implant is less compared to lower profile implants. That means that for a given volume, the implant won’t fill the breast side-to-side as much compared to lower profile implants, leaving a wider gap between the breasts.
- There are other potential compromises, but you get the point...
Here is a product that had limited applications three decades ago and, although useful for a very few specific breast deformities, has considerable potential compromises. Nevertheless, it was reintroduced as a “new” product and continues to be used by some surgeons.
When one company recycles old designs that are successful in the marketplace (patients and surgeons either don’t know history and implant-soft tissue dynamics or don’t care and buy the products), other companies often follow. When Mentor enjoyed success with the resurrected and recycled round, high profile design, Inamed/Allergan (formerly McGhan Medical) rapidly followed and reintroduced similar designs.
Since reality rarely changes, and the compromises listed above still apply, our prediction is that enthusiasm for round, high profile implants will decline as surgeons and patients experience potentially increased tissue compromises such as shrinkage (atrophy) of breast tissue (parenchyma) and excessive stretching, thinning, and sagging of the lower breast skin envelope.
The important messages for patients from the “new” high profile implant story:
- High profile implants do not necessarily produce more projection in the patient’s breast.
Remember that a higher-profile implant compresses the breast tissue more. What is gained by the few millimeters of additional projection of the implant is often lost by the compression and shrinkage (atrophy) of the overlying breast tissue over time. - Don’t rush to something “new” until you know the history.
Products that are really “new” and better will have stood the test of time and are supported by valid scientific data, not just marketing hype. - Don’t request something “new” until you and your surgeon have discussed potential long-term consequences.
- Don’t select something “new” if your surgeon can’t (or won’t) provide you in-depth explanations of how that product may interact with your tissues over time.
Lesson 2
How “old and bad” can suddenly become “new and okay”: The resurrection of old silicone-gel implant designs
Interestingly, the basic design of the old-style round, noncohesive silicone-gel-filled implants that were banned by the FDA in 1992 have suddenly become available again to patients in the United States in November of 2006. How can this be?
A large body of scientific evidence has shown that the old silicone gel implants do not cause many of the diseases or conditions that they were accused of causing. Nevertheless, the same data also show that this design of implant had a relatively high shell failure rate and that when the shells failed, the non-cohesive silicone gel in some instances escaped from the surrounding capsule and caused local complications in the breast or adjacent tissues. In addition, compared to saline-filled implants, the recently FDA-approved old-style silicone-gel implants also have a very high capsular contracture rate of 13.2 percent in the Allergan study and 8.1 percent in the Mentor study. So, why would the FDA allow the product back on the market? Is the round, non-cohesive silicone-gel implant that may reenter the market significantly different from the 1992 or earlier product that was banned? Go figure.
The facts are that the round, non-form-stable, silicone-gel-filled implants that have again become available in 2007 are not substantially different compared to the products that were banned in 1992 and not really very different compared to similar products from the 1970s—three decades ago! Although today’s round, non-cohesive gel implants incorporate a barrier to “gel bleed” (minuscule amounts of silicone molecules escaping through the shell), and the shells may be somewhat more durable, the gel is essentially unchanged from previously, and the implants remain underfilled, allowing shell collapse and/ or folding that could compromise shell life. So, why are they back?
Table 5-1 compares data on salineand silicone-gel-filled-implants from FDA PMA studies to peer-reviewed data that the author has published in Plastic and Reconstructive Surgery. Scientific references to this data are listed after the table.
Compiled December 5, 2006, by John B. Tebbetts, M.D. Revised February 8, 2007.
Mentor 5-and 7-year saline follow-up were 5% and 50% respectively, so the 3-year data are more reliable.
1 Tebbetts, J. B. Patient acceptance of adequately filled breast implants. Plast. Reconstr. Surg. 106(1): 139-147, 2001.
2 Tebbetts, J. B. Dual plane (DP) breast augmentation: Optimizing implant-soft tissue relationships in a wide range of breast types. Plast. Reconstr. Surg. 107: 1255, 2001.
3 Tebbetts, J. B. Achieving a predictable 24-hour return to normal activities after breast augmentation, part I: Refining practices using motion and time study principles. Plast. Reconstr. Surg.109: 273-290, 2002.
4 Tebbetts, J. B. Achieving a predictable 24-hour return to normal activities after breast augmentation, part I: Refining practices using motion and time study principles. Plast. Reconstr. Surg. 109: 293-305, 2002.
5 Tebbetts, J. B. Achieving a zero percent reoperation rate at 3 years in a 50-consecutive case augmentation mammaplasty PMA Study. Plast. Reconstr. Surg. 118(6): 1453-1457, 2006.
6 U. S. Food and Drug Administration. Product labeling data for Mentor and Allergan/ core studies of saline-filled implants. http://www.fda.gov/cdrh/breastimplants/labeling.html. Accessed January 1, 2007; FDA web site updated November 17, 2006.
7 U. S. Food and Drug Administration. Product labeling data for Mentor and Allergan/Inamed core studies of saline-filled implants. http://www.fda.gov/cdrh/ breastimplants/labeling.html. Accessed December 5, 2006; FDA web site updated November 17, 2006.
Important Facts About the Silicone Gel Implants Approved by the Fda in November Of 2006
The categories of silicone-gel-filled implants approved by the FDA on November 17, 2006, are smooth shell, round, silicone gel implants that ARE NOT FORM STABLE. (They collapse when tilted upright due to the amount of filler the manufacturer places in the shell.) Shell collapse and folding have been shown to be significant factors that shorten the life of an implant shell. While Mentor markets these products as containing “Memory GelTM”, in fact the implant gel does not have “memory” and does not return to its original shape when deformed. Although all silicone gel is “cohesive” to some degree, none of the gels approved in 2006 is adequately cohesive to be “form stable,” meaning that it maintains its shape or regains its shape following deformation.
When considering the round, smooth, non-form stable implants approved in 2006, patients should be aware of the high reoperation rates associated with these products, of the high capsular contracture rates associated with these products, and that the reported shell failure rates are early reports at a maximum of four years. Table 5-1 summarizes key data from the Allergan and Mentor FDA studies of these products and compares the rates to similar rates for saline implants. Although the FDA has not approved form-stable silicone-gel products, data on the Allergan Style 410 form-stable cohesive-gel implant reported to the Canadian equivalent of the FDA by Allergan in 2006 is included for comparison.
The data in this table is all data from FDA or Health Canada supervised and monitored studies. This data strongly suggests that compared to either saline or conventional silicone gel implants, the Allergan Style 410 form-stable, cohesive-gel anatomic implant has a lower shell failure rate and a dramatically lower capsular contracture rate. The 410 also virtually eliminates wrinkling problems associated with saline implants in these studies.
The excessively high reoperation rates in all of these studies is unquestionably related more to surgeon issues than to implant issues. The most common causes of reoperation in all of these studies include implant size or style change, capsular contracture, bleeding or fluid collection, and implant malposition. Each of these causes relates directly to patient and surgeon decisions in implant selection and to surgeons’ techniques and accuracy in the operating room. During the past decade, studies that Dr. Tebbetts has published1-4 have demonstrated that these reoperation rates can be dramatically reduced to approximately 3% by using specific tissue measurements and proved processes for surgical planning and surgical techniques.5,6 In the most recent PMA study for the Style 410 form-stable, cohesive-gel implant, Dr. Tebbetts published a series of fifty consecutive augmentation patients who had a 0 percent reoperation rate at three years follow-up.7 This is the first peer reviewed and published report of a zero percent reoperation rate at 3 years for a consecutive patient series by a single surgeon in any FDA PMA study of breast augmentation.
The FDA almost certainly recognizes the errors made in 1992 when banning a product in response to a media frenzy, at least partially for the wrong reasons. The alternative, saline filled implants, although offering a different set of trade-offs, aren’t perfect either, with deflation and reoperation rates in clinical studies submitted to the FDA that fall short of wonderful (more about that later). Saline-filled implants are perceived by many patients and surgeons to feel less natural compared to the old silicone-gel implants, and there is a definite demand for “naturalness,” even at the expense of shell durability.
Is there another alternative? Yes, cohesive, form-stable silicone-gel implants, with the most form-stable design under PMA studies for the FDA being the Allergan Style 410 anatomic cohesive-gel implant. The obvious question is why have the old round, non-cohesive, silicone-gel implants become available again before the newer, anatomic, cohesive, form-stable gel designs? The basic answer is that Inamed (now Allergan) management made a conscious decision to attempt to get FDA approval for the older design and instituted the studies on the older designs prior to initiating clinical PMA studies for the newer design. Why would they do that? Their answer might be that the FDA mandated studying the older implants first, but if so, where is the logic in that mandate? A skeptic might also consider that the potential market for the older type gel implant is potentially much larger than for newer designs because the newer implant designs place more demands on surgeons, and many surgeons may not want to adopt new designs that are more demanding.
Regardless, patients should be aware that the round, non-form-stable silicone-gel implants that were approved by the FDA on November 17, 2007, are not substantially different compared to three-decade-old round, non-cohesive gel implants. Even if clinical data to the FDA appear encouraging initially, the longer term failure rates of the shells of these implants will not be known definitively for at least a decade. They may feel more natural compared to saline or newer design cohesive gels (although no objective data exists to support this theory), but the difference is minimial in most patients, and there may be a substantial trade-off when long-term durability is compromised for perceived and unproved “naturalness.”
Lesson 3
Why do “wonderful, new” designs suddenly disappear?
History can teach important lessons. Consider for a moment the history of three “wonderful, new” types of implants that were introduced in the United States during the past decade: The Misti Gold implant, the TrilucentTM peanut-oil- or soybean-oil-filled-implant, and the PIP pre-filled saline implant. Each of these implants was heavily marketed prior to introduction, each had limited clinical use prior to introduction, and the media and the public rushed to embrace (albeit transiently) the new products. Each has either disappeared completely or is currently severely compromised in the marketplace. Why?
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References
1 Tebbetts, J. B. Patient acceptance of adequately filled breast implants. Plast. Reconstr. Surg. 106(1): 139-47, 2006.
2 Tebbetts, J. B. Dual plane (DP) breast augmentation: Optimizing implant-soft tissue relationships in a wide range of breast types. Plast. Reconstr. Surg. 106(1): 273-290, 2002.
3 Tebbetts, J. B. Achieving a predictable 24-hour return to normal activities after breast augmentation, part I: Refining practices using motion and time study principles. Plast. Reconstr. Surg. 109(1): 273-290, 2002.
4 Tebbetts, J. B. Achieving a predictable 24-hour return to normal activities after breast augmentation, part II: Patient preparation, refined surgical techniques and instrumentation. Plast. Reconstr. Surg. 109(1): 293-305, 2002. BREAST IMPLANTS: The Devices and the Choices
5 Tebbetts, J. B. A system for breast implant selection based on patient tissue characteristics and implant-soft tissue dynamics. Plast. Reconstr. Surg. 109(4): 1396-1409, 2002.
6 Tebbetts, J. B., and Adams, W. P. Five critical decisions in breast augmentation using 5 measurements in 5 minutes: The high five system. Plast. Reconstr. Surg. 116(7): 2005-2016, 2005.
7 Tebbetts, J. B. Achieving a zero percent reoperation rate at 3 years in a 50 consecutive case augmentation mammaplasty PMA study. Plast. Reconstr. Surg. 118(6): 1453-1457, 2006.
8 U. S. Food and Drug Administration. Product labeling data for Mentor and Allergan/Inamed core studies of saline-filled implants. http://www.fda.gov/cdrh/breastimplants/labeling/mentor_patient_labeling_5900.html. Accessed December 5, 2006; FDA web site updated November 17, 2006.
9 U. S. Food and Drug Administration. Product labeling data for Mentor and Allergan/Inamed core studies of saline-filled implants. http://www.fda.gov/cdrh/breastimplants/labeling.html. Accessed December 5, 2006; FDA web site updated November 17, 2006.