According to the International Society of Aesthetic Surgery, plastic surgery involving breast implants is still one of the most common procedures in the world.

Hundreds of thousands of new patients have implants for the first time every year while another group just as large will have them replaced. For many years breast implants have been considered safe and harmless for patients. So, what has happened? Recently, there has been a lot of fuss in the media about the safety of breast implants, especially referring to a new type of cancer related to them.

They are talking about the ALCL. ALCL stands for anaplastic large cell lymphoma and according to the Lymphoma.org website it represents 16% of all T-cell lymphomas diagnosed every year [1]. So, what is new?

In 2011, the FDA issued a warning that a possible new type of ALCL, now called by the World Health Organization (WHO) as BIAALCL (Breast Implant-Associated), had been found in patients after a long time since the first implantation (average of 8 years) [2]. The first diagnosed case was in 1997. The WHO defines the BIA-ALCL as a malignant type of cancer and should be staged and treated as such.

It seems scary, but it is not! The last FDA update defines this disease as uncommon and highly curable when diagnosed at an early stage. Today, all plastic surgeons around the world have a guideline for how to investigate, diagnose and treat patients with ALCL [2].

How can a patient “get” ALCL? As I mentioned before, this is a long term evolution and uncommon disease. There are several theories under investigation at the moment, and they include: inflammation by friction related to implant roughness, presence of silicone particulates or debris released from the implant shell, bacterial contamination and genetic predisposition. Several groups of scientists are working really hard to crack these and I believe they are close to obtaining reassuring findings. However, the best scientific data we have to date is a medical paper published in one of the most renowned medical journals specialized in Plastic Surgery (PRS) with a thorough analysis of the Australian implants registry data [3]. In April this year Australian researchers updated the risk numbers which are reflected on the American Society for Aesthetic Plastic Surgery (ASAPS) website [4]. The risks for a patient, depending on the type of implant they have, to develop ALCL after 10 years of implantation is:

- 1 in 3200 with Biocell implants, so considering that women have 2 breast implants it means the risk is 1 in 1600 patients

- 1 in 2800 with polyurethane implants, so the risk is 1 in 1400 patients

- 1 in 82000 with Siltex implants, so the risk is 1 in 41000 patients

- No cases registered with Smooth implants

So, what is very clear until now is that not all types of implant surfaces share the same risks. Any other information disclosed so far is under scientific examination and has not yet obtained final confirmation.

Based on the only proven evidence since the FDA alert in 2011, I have personally made a choice to use a different type of implants for the last 6 years. Why have I changed? Because I honestly believe that only technology can improve medical devices and make them safer for patients. When I was introduced to Motiva in 2012, they had a different approach to any other company of breast implants I used before. They believed that they should use technology to create a breast implant that at least would be more “friendly” to patients and create less friction, less irritation and less inflammation. They used their technology to create a smooth biocompatible cell friendly surface that they believe would cause fewer problems to patients. I took a chance back then and today after thousands of implantations and many medical publications, I am proud to say that we have achieved some of the lowest complication rates with breast implants known to the specialty so far [5].

Are Motiva implants ALCL free then? Nobody can absolutely confirm that! But what I can categorically say to all my patients is that Motiva basically produces enhanced smooth implants and so far, in any database in the world with over millions of smoothes implants in patients since the 60’s, there is not a single ALCL case with a primary smooth breast implant. Thus, the chances of a patient developing ALCL with Motiva is at least the same as with a smooth implant as far as we can predict.

The surgeon’s job is to be honest and present the risks and complications to all patients and help them decide what is best for them

Finally, many patients ask me: should I change my old breast implant to a smooth one, even if I have no problems? That is a really difficult question, because replacing an implant is also a surgical procedure with its own risks and complications. Moreover, there is no recommendation from any regulatory authority that suggests that yet. When I am asked this question, our job is to expose all the known evidence and help the patient to decide. As I explained before, some implants have more risks than others and these risks should be taken into consideration as well. On a personal level, if a family member today has one of the high risk ALCL types of implants, I would definitely recommend that they highly contemplate the replacement option.

Many years ago, I swore an oath that basically said “I shall not cause harm”. This is how I live my life because plastic surgery is my passion, and keeping my patients safe is what motivates me every day.

Disclosures

The author is a member of the Medical Advisory Board of Establishment Labs but this paper received no funds or contributions to its publication.

This Editorial represents Professor Sforza’s personal views as a consultant, a responsible father of two daughters and a proud husband and does not reflect the views of any clinics or companies he might be associated with.

References

1. Lymphoma Research Foundation (2018) Anaplastic Large Cell Lymphoma. [Ref.]
2. USFDA (2018) Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL). [Ref.]
3. Loch-Wilkinson A, Beath KJ, Knight RJW, Wessels WLF, Magnusson M, et al. (2017) Breast Implant-Associated Anaplastic Large Cell Lymphoma in Australia and New Zealand: High-Surface-Area Textured Implants Are Associated with Increased Risk. Plast Reconstr Surg 140: 645-654. [Ref.]
4. Stevens WG (2018) Update from the President. The American Society for Aesthetic Plastic Surgery, USA. [Ref.]
5. Sforza M, Zaccheddu R, Alleruzzo A, Seno A, Mileto D, et al. (2018) Preliminary 3-year evaluation of experience with silksurface and velvetsurface motiva silicone breast implants: a single-center experience with 5813 consecutive breast augmentation cases. Aesthet Surg J 38: S62-S73. [Ref.]

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Article Information

Article Type: EDITORIAL

Citation: Sforza M (2018) Breast Implants Associated ALCL (BIAALCL): A Personal Overview for Patients. J Surg Open Access 4(4): dx.doi.org/10.16966/2470-0991.176

Copyright: © 2018 Sforza M. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

Publication history: 

Received date: 03 Dec, 2018

Accepted date: 05 Dec, 2018

Published date: 07 Dec, 2018