Plastic surgery Korea KIES-U, Current Status of Breast Augmentation

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Plastic surgery Korea KIES-U, Current Status of Breast Augmentation
What Is Behind The Recent Popularity of Microtextured Implants?



The science of plastic surgery is rapidly changing. The changes are so fast-paced that I started comparing today’s trends to last month’s, not last year’s. Things that were thought impossible before are becoming reality before our eyes. In such a volatile environment, we are pushing on without knowing where we are going. However, we still need to prepare for the future and that starts with reviewing the past. Dr. Joo-hyuck Lee of KIES-U Plastic Surgery Korea leads a new series on the present and future of plastic surgery.

What is behind the recent popularity of microtextured implants?

I am seeing more and more patients asking about microtextured implants for breast augmentation. Sebbin or BellaGel products are some of the most popular. Many doctors may still be unfamiliar with the term ‘microtextured implants.’ In the past, Allergan’s Biocell was categorized as macrotextured implants and Mentor’s Siltex as microtextured implants [Derby, Brian M.; Textured Silicone Breast Implant Use in Primary Augmentation: Core Data Update and Review, PRS Jan2015;135(1), 113-124]. However, such categorization was used within the academia and was not widely used by the public.

The current popularity of the term microtexture does not accurately reflect the scientific concepts and is being rampantly used as a marketing keyword by distributors and even some plastic surgeons.

The microtextured implants of Sebbin, a French manufacturer, have become very popular in Korea. Advertisements claiming they offer a natural texture with a lower risk of capsular contracture have successfully won over the public. And naturally, Sebbin’s implants have become very hard to come by in Korea. Catching on to this new trend, BNS Med quickly developed a microtextured implant line called BellaGel and entered the Korean market.

These microtextured implants have micro bumps on the surface that are only 30-40 micrometers wide. This creates a very smooth surface. What is the reason for designing the bumps to be that small?

Sebbin’s product catalog does not mention “natural feeling” anywhere to describe their microtextured implants. 

1. Ease of insertion and less friction on the tissues.
2. Minimizing the rate of capsular contracture.

It does, however, explain that the implants are “textured and are not prone to capsular contracture. The microtextured surface makes it easy to insert them.” However, there is no clinical or scientific data supporting this claim. It is surprising that many people have accepted as a fact that microtextured implants are safe from capsular contracture due to aggressive marketing.

 Any surgeon specializing breast augmentation would know that the resistance of textured implants to capsular contracture is irrelevant in Korean patients who mostly go through submuscular placement. When McGhan first developed the textured shell, the primary goal was to promote tissue ingrowth and prevent capsular contracture. However, there is a growing consensus that they failed in achieving this goal. 

Early on, Tebbetts already explained that the textured shell is not effective in preventing capsular contracture.¹ He found that some plastic surgeons mistakenly think that tissue adherence of the textured shell is important for preventing capsular contracture. However, FDA’s PMA study (comparing textured and smooth saline implants) already found there is no difference in the incidence of capsular contracture between the two types. 

Findlay² also explains that he has used a 410 implant which resulted in higher incidences of capsular contracture, later seroma and double capsule. He uses only smooth walled implants. Allergan’s Biocell has a weak tissue adherence that cannot resist against the shear force and gets separated, leading to late seroma and double capsule.

Wan et al. even reported that after corrective surgeries of capsular contracture, there was a significantly higher rate of capsular contracture recurrence with textured shell compared to the smooth shell.³ It would be more correct to say that texturing does not reduce the risk of capsular contracture but reduces malposition and rotation due to increased friction.

Polyurethane was seen to cause definite tissue ingrowth and a significantly lower incidence of capsular contracture. On the other hand, previous microtextured products such as Siltex or macrotextured products like Biocell do not allow tissue ingrowth but loose tissue adherence. This does not prevent capsular contracture.  

Allergan (formerly called McGhan) first used a salt loss technique for texturing which separates the salt crystals from the shell. This creates a rough surface with micro bumps resembling air bubbles.

Electron microscopic image of Biocell shell is shown in Image 1. Allergan Biocell’s pores range 200~500um in width and 600~800um in depth.

Image 1. Source: S. Barr, BSc, Current Implant Surface technology: An Examination of Their Nanostructure and Their Influence on Fibroblast Alignment and Biocompatibility,; Open Access Journal of Plastic Surgery, 2016:9:198-217.

The Biocell implant surface is rough with large pores and plastic surgeons call it “macrotextured.” Naturally, this rough surface does form a strong adhesion to the adjacent tissues. However, the adhesion can be characterized as a weak Velcro-like attachment that can separate easily. This cannot be compared to the tissue ingrowth of polyurethane and does not prevent capsular contracture.

Mentor, who developed textured implants around the same time as Allergan, used a very different approach to create textured implant shells. They use negative imprinting for texturing implant shells and Mentor is the only major manufacturer of breast implants that uses this method. Negative imprinting results in a very refined, gentle texture. The electron microscopic image is shown in Image 2.

Image 2. Source: S. Barr, BSc, Current Implant Surface technology: An Examination of Their Nanostructure and Their Influence on Fibroblast Alignment and Biocompatibility,; Open Access Journal of Plastic Surgery, 2016:9:198-217.

The above image is drastically different from Allergan’s texturing. The Siltex implant surface seems more refined than that of Biocell. Microbumps on Mentor implants are 40um wide and 203um deep. Macrotextured and microtextured surfaces can be compared as below.

Image 3.
Silimed, another FDA approved implant, uses evaporation for texturing. The microbumps on the implant surface are 150~300um wide and 80~150um deep, which fall somewhere between those of Siltex and Biocell. The electron microscopic image of True Texture implant surface is shown in Image 4.

Image 4. Source: S.Barr, BSc, Current Implant Surface technology: An Examination of Their Nanostructure and Their Influence on Fibroblast Alignment and Biocompatibility,; Open Access Journal of Plastic Surgery, 2016:9:198-217.
We call Sillimed’s True Texture “intermediate texture” which lies between the very fine texturing of microtexturing and rough texturing of macrotexturing. Some doctors also categorize True Texture as macrotextured.  

In my experience of performing revision surgery, Biocell adhered to surrounding tissues like Velcro as shown in Image 5. It separates easily with a slight pull.  

Image 5.
The relatively smooth surface of Siltex does not allow it to adhere to surrounding tissues, which results in poor tissue adherence. In some cases, water (slight seroma) can be seen around the implant. Findlay has stated that he avoids using Siltex for this reason.

In the beginning, due to poor tissue adherence, Siltex fell behind Biocell in the market. However, as anaplastic large cell lymphoma (ALCL) is becoming an issue in the US, many surgeons are going back to Siltex or True Texture.

A rough surface provides more space for microorganisms to form (including bacteria). This is along the same line of logic that a towel catches moisture from the skin better than a smooth cloth. If so, would a textured surface provide more opportunities for capsular contracture? There were a few papers that reported that the textured shell did lead to a higher incidence of capsular contracture compared to the smooth shell. And there were many studies that reported different findings. How can we be certain which is the truth?

Capsular contracture is one of the most serioust complications of breast augmentation. As there are varying opinions on which shell type causes this complication, I ask this question.

Would it be possible that the doctor’s surgical technique is directly related to the risk of capsular contracture regardless of the type of implant used?

It would benefit us all to pay more attention to peer reviews, reliable studies as well as our own clinical experience and less attention to the aggressive marketing by manufacturers and distributors.

I wonder if the reason behind numerous published studies on this topic reporting such widely varying results would be that the surgical skills and techniques may have a bigger impact on the incidence of capsular contracture rather than the type of implant.

I find consultations to be often difficult as patients rely more on their own online research and information on SNS than on the doctor’s words. They often ask me why I say the opposite of what other doctors are saying. They say that other doctors tell them the textured shell causes less capsular contracture and does not require post-surgical massaging and the smooth shell has a higher risk of capsular contracture and requires massaging. When the patient already has a firmly preconceived notion about which implant they want, it is very difficult to persuade them otherwise.  

I guess many plastic surgeons are saying that the textured implant shells are superior. However, the consensus on capsular contracture prophylaxis focuses on clean operation and non-traumatic technique. There is never any mention of textured shell, or post-surgical prevention of capsular contracture. 

Table 1. The 14 point plan for preventing capsular contracture. It cannot be said that all surgeons agree with this but various peer reviews have mentioned similar measures for preventing capsular contracture in the past few years (Source: William P. Adams, Jr., Macrotextured Breast Implants with Defined Steps to Minimize Bacterial Contamination Around the Device: Experience in 42,000 Implants., Plast. Reconstr. Surg. 140:427,2017).
It has been over thirty years since the introduction of textured implant shells but its association with a lowered risk of capsular contracture is yet to be shown. It is worrisome that many doctors recommend microtextured implants, which have been only recently introduced, as causing less capsular contracture and not requiring massaging without any clinical evidence.  

Do the tiny bumps of only 40 micrometers in diameter help prevent capsular contracture? Also, how durable and free from other complications is the microtextured shell? I presume that most manufacturers are not confident about the risk of rotation as they are not producing anatomic implants. However, there is no agreement or data on the difference in the risk of rotation between macrotextured and microtextured anatomic implants.  

I have not seen any paper that examined these new implant products. Data on Motiva implants which claim to be nanotexured is simply nonexistent. The current trend favoring microtextured implants in Korea completely ignores any scientific consensus on the matter and is solely driven by marketing experts. I wonder if the medical market and patients are falling victim to their very effective campaigns.  

References

1. John B. Tebbetts, Augmentation Mammaplasty: Redifining the Patient and Surgeon Experience. Philadelphia: Elsevier; 2009. pp.129.

2. Elizabeth Hall Findlay, Aesthetic Breast Surgery; Concepts&techniques. St. Louis: QMP: 2011. Pp.166

3. Wan, Dinah: Revisiting the Management of Capsular Contracure in Breast Augmentation: A Systematic Review., PRS 2016:137(3), 826-841.




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