With interest, I read the article in the January issue of the Journal by Rubi et al., “Comparing Round and Anatomically Shaped Implants in Augmentation Mammaplasty: The Experts’ Ability to Differentiate the Type of Implant” (Plast Reconstr Surg. 2017;139:60–64)1 and its discussion by Dr. Lista.2 Some comments to the authors of this article are in order.
I have concerns that this article further intensifies the debate and adds erroneous assumptions, based on poor methodology and study design. Arguably, I could preselect patient images to locate both round and lower height shaped implant subjects that might confound blinded raters, if I wanted to make a false premise that there is no difference between implant shapes. Specifically, similar clinical outcomes can be produced when an underfilled round device is used and compared to a moderate-height, moderate-projecting shaped device. There are major flaws in the article that should have been discussed further, as follows:
- In the Patients and Methods section, there was little description of the actual devices selected, how they were selected, their engineering dimensions, gel characteristics, gel fill–to–shell capacity ratio, or the manufacturer.
- The authors used a methodology that selected a specific implant volume, not dimensions. What might have occurred if similar base diameter devices were used instead of volume (not discussed)?
- There was no mention of correlation between implant base diameter and breast base width or other commonly used tissue characteristics that are used when planning breast augmentation surgery.
- There was no mention of how the inframammary fold was managed.
- The body mass index of patients was not controlled. The patients were not consecutive or randomized. Sternal-nipple measurement distances were not controlled (or even disclosed).
- No mention was made of the follow-up interval before images were reviewed.
- An explanation is in order by the authors as to why preoperative and postoperative images of only round implant breast augmentation (Fig. 1) were used. A shaped implant outcome should have been shown to demonstrate the academic integrity of this article.
- Why was three-dimensional imaging not used as part of the rating process? This is a more sensitive measure of breast shape changes and volume distribution than the process used by the authors (i.e., two-dimensional photographs).
- There has to be greater disclosure within the article regarding the devices used so that the reader can make realistic assessment of a particular brand of implants and how they perform within the body after implantation in similar subjects who have similar tissue characteristics.
Conversely, there are ample clinical outcomes in the published literature that show the difference. This then becomes the exercise in statistical analysis that the authors used to validate their erroneous premise that observers cannot tell the difference between shaped and round devices. The goal of breast augmentation is to add both shape and volume to the breast and to achieve as natural as possible a normal distribution of volume (45 percent upper pole, 55 percent lower pole). Some patients require a round device, whereas others require a shaped device to achieve a great long-term outcome. It has been my experience that there are visible differences between round and shaped devices at similar volume, even more so now with the latest generation high fill-to-shell volume ratio and firmer gel availability. Both new-generation round and shaped devices are highly differentiated, and the distribution of gel is affected by a variety of factors.
In closing, I believe that the article has many deficiencies that should have been noted before publication. It only confuses the reader into accepting a premise by Rubi et al. that there are nondiscernible outcome differences between the two styles of implants.
The author is a consultant for Allergan, Solta, Keller Medical, and New Beauty magazine, and an investigator for Allergan and Syneron. He holds a patent for Pfizer (antisense oligonucleotide drug).
Mark L. Jewell, M.D.Plastic SurgeryOregon Health Science UniversityPortland, Ore.Private practiceEugene, Ore.
1. Rubi CG, Lozano JA, Pérez-Espadero A, Leache ME. Comparing round and anatomically shaped implants in augmentation mammaplasty: The experts’ ability to differentiate the type of implant. Plast Reconstr Surg. 2017;139:6064.
2. Lista F. Discussion: Comparing round and anatomically shaped implants in augmentation mammaplasty: The experts’ ability to differentiate the type of implant. Plast Reconstr Surg. 2017;139:6566.