Breast Implants ~ Cutting Through Cohesive Confusion
Breast Implant Choices
Available Implant Types
From reading The Best Breast book, you are aware of the various types of implant that are available. A new edition of the The Best Breast is in progress, but until the book is available, we want you to be aware of changes in implant alternatives and issues that have occurred since the last edition of the book was written more than 5 years ago.
The following information is summarized for your convenience. If you would like more information or would like a list of the scientific studies and FDA studies from which the data we mention is derived, just ask and we will be happy to supply a list of references.
Two categories of implants are currently available: saline-filled implants and silicone gel filled implants. Our experience and that of many other surgeons shows conclusively that saline implants have a much shorter shell life compared to silicone gel implants. Earlier failure of the shell of saline implants cause deflations that require reoperation and replacement of the implant. While replacement is straightforward, additional reoperations subject patients to more costs and more risks. Silicone gel filled implants unquestionably have a longer shell life, and therefore minimize the number of reoperations you are likely to require over time. All implants are devices. All implants will ultimately fail. The time to failure is not predictable, but in our experience, silicone gel implants have lasted more than twice as long as saline filled implants.
In the past, data suggested that saline filled implants had a lower risk of causing capsular contracture compared to silicone gel filled implants. That is no longer true. Both types of implants have similar rates of capsular contracture, so risks of capsular contracture should not affect your choice of implant.
If you are more concerned about any issues with silicone gel filled implants, saline filled implants are always an alternative. It’s your choice. Dr. Tebbetts can deliver the same visual aesthetic results with either type of implant. Our primary concern is to limit your risk of reoperations, and silicone gel implants do that better than saline implants.
Implant Shell Surface Alternatives
Implants are available with smooth shell surfaces and textured shell surfaces. A decade ago, data suggested that textured surface implants had a lower rate of capsular contracture compared to smooth shell implants. That is no longer true. Current data indicate that smooth and textured surface implants have similar rates of capsular contracture, hence risks of capsular contracture should not affect your choice of a textured or smooth shell implant.
Types of Silicone Gel Filled Implants
Two basic shapes of silicone gel filled implants are currently available: round and shaped (anatomic). Shaped implants are available with a more cohesive gel compared to round implants. Currently, Allergan manufactures the Style 410 shaped, cohesive gel implant, Sientra manufactures shaped, cohesive implants, and Mentor manufactures a shaped implant, the Contour Profile Gel or CPG (not yet FDA approved). The silicone gel in the Allergan Style 410 is more cohesive outside the body compared to the Mentor CPG and the Sientra devices, and both companies market the more cohesive gel as less likely to migrate if the implant ruptures. However, no manufacturer, even after a 13 year FDA PMA study, has shown the degree to which cohesiveness is maintained in the body after implantation. Until we know those facts, we cannot credibly assume that the gel will remain intact after shell rupture.
Shaped, more cohesive implants are currently available from two manufacturers, Allergan and Sientra. Mentor is still awaiting FDA approval of their highly cohesive, shaped implant.
Perhaps the most important information for patients is that to date, no valid, comparative scientific study has shown any superiority in any way of a shaped over a round breast implant. In addition, no valid comparative scientific study has shown any superiority of the most highly cohesive filled implants over implants with silicone gel of lower cohesivity.
Although many patients (and some surgeons) advise patients that shaped implants deliver a predictably better or different aesthetic result and breast appearance compared to round implants, no valid scientific study has ever confirmed those marketing claims. For more than two decades, Dr. Tebbetts has delivered and published breast augmentation results using both round and shaped implants, and viewing the results, expert surgeons cannot distinguish whether a round or anatomic implant was used. Simply put, a shaped implant does not deliver a better aesthetic result compared to a round implant when an expert surgeon uses both types.
Information that has Changed since The Best Breast 2 was Published
As more data has accumulated from FDA PMA studies, it has become apparent that manufacturers have made significant improvements in areas that we previously criticized about round, smooth, silicone gel filled implants:
- Manufacturers have increased the fill volume to shell volume ratio. This means that for a specific size implant shell, manufacturers are putting more fill into the shell, and this decreases the degree of shell collapse and shell folding that the implant is likely to experience after it is implanted. Shell folding is a major cause of shell failure over time, and data indicates that the current generation of smooth shell, gel filled implants have a substantially longer shell life potential.
- Manufacturers have increased the degree of cohesiveness of the silicone gel in round, smooth gel filled implants. While not as cohesive as the gel in the most highly cohesive “gummy bear” implants, the differences are less. Allergan has decreased the cohesiveness of the gel in the family of Style 410 implants compared to Dr. Tebbetts’ original design for the gel. In the body, cohesive gels become less cohesive over time, and with shell failure, the gel does not retain the same form as shown when a wedge is cut out of an implant prior to implantation.
- As mentioned previously, the previous higher rate of capsular contracture with smooth shell, silicone or saline implants no longer exists. Smooth shell implants have essentially the same rate of capsular contracture compared to textured implants.
- The possible association of textured surface implants with lymphoproliferative disorders or ALCL (anaplastic large cell lymphoma) is yet unproved, and even if an association exists, the conditions are exceedingly rare. Understandably, despite the rarity or scientific proof of an association with textured surface implants, patients may be more concerned about any risk, however small, that may be associated with textured implants.
- In the hands of experienced surgeons, the aesthetic results of a shaped, textured surface implant cannot be predictably distinguished from the aesthetic results achievable with round, smooth shell implants.
- Round, smooth gel filled implants are considerably more cost effective compared to shaped, textured surface implants.
- The potential benefits of a more highly cohesive gel, though seemingly logical, have not been conclusively confirmed in scientific studies. Gel migration if the shell fails, provided the capsule is intact, has not been proved scientifically to be different with round, smooth gel implants compared to shaped, more highly cohesive, textured shell implants.
In summary, round, smooth, silicone gel implants have improved significantly in many respects, and we now consider this type of implant an equally sound choice for patients compared to the Allergan or Sientra shaped implants, which are considerably more expensive, with no scientifically proved benefits.
Important Information from Behind the Scenes
As you are aware from reading The Best Breast book, Dr. Tebbetts designed the Allergan Style 410 breast implant in 1993. We have been a participating investigator in the FDA PMA studies for both the Mentor CPG and the Allergan Style 410. As PMA data from these studies and from similar studies of round, smooth gel implants has accumulated over 10 years, the differences in implant longevity and reoperation rates are becoming more and more similar, indicating that some of the perceived advantages of the more highly cohesive gel implants are likely not as significant as they seemed earlier in the studies. If shaped, cohesive gel implants are significantly more expensive compared to round smooth gel implants, we believe that the devices should be clearly better and that the manufacturers should have conclusively proved that shaped implants are better. No manufacturer or surgeon data proves the superiority of shaped over round implants with scientific validity.
Allergan gains only 5% of its revenues from its breast implant sales. 95% of its revenues come from other sources, primarily its injectable products—Botox and dermal fillers. Manufacturers historically have been very hesitant to push the FDA for approval of products, because the FDA pushes back and delays approval of the company’s other products. Allergan finally received FDA approval of the Style 410 implant after 13 years.
Sientra purchased a company originally based in South America that approximately 15 years ago, copied the design of the original Style 410 implant that Dr. Tebbetts designed. That company and Sientra have subsequently changed many characteristics of their shaped implants, so no valid comparisons can be drawn to their designs as compared to the original Style 410.
It is categorically impossible to see a predictable, visual difference if Dr. Tebbetts implants either a round, smooth gel implant, or a shaped, textured implant. Any experienced surgeon who has used every type of implant available can create exactly the same aesthetic result using several different types of implants. So what you may think you see when you look at an implant on a table or in your hand has nothing to do with how that implant will appear in the breast when implanted by an experienced surgeon.
If there is no predictable visual difference in round smooth versus shaped cohesive gel implants, what about the issue of gel migration when and if the implant shell ruptures? Patients should be aware that Allergan reduced the cohesiveness of the gel in the Style 410 without Dr. Tebbetts’ approval in order to make the implant feel softer to surgeons outside the body. These changes were made entirely based on marketing considerations and not on any scientific tests or data. Hence we cannot assure that the characteristics of the implant continue to be as Dr. Tebbetts designed. The gel in the CPG was already less cohesive compared to the Style 410. All of the information contained in The Best Breast book is based on Dr. Tebbetts’ original design of the Style 410 as a full height, shaped implant. All current manufacturers have marketed a wide range of varying heights and shapes without adequate scientific evidence to prove that all these variations perform to the level of Dr. Tebbetts’ original design. When cohesive gel implants rupture, under FDA study requirements, surgeon investigators must return the ruptured device to the manufacturer for analysis (post-retrieval analysis). Amazingly, when returned to Allergan, all of the gel is summarily discarded and not evaluated to determine changes that have occurred in the gel while it has been in the body. Only the shell is evaluated. Despite Dr. Tebbetts’ continued protests and demands for gel analysis, no data has been provided by Allergan to surgeons.
We do not choose implant types for patients. We provide you the information to make the choice, and will help in every way during the decision process.