International discussions and public interest in this topic grew drastically following FDA’s announcement. Currently, BIA-ALCL is a hot issue in the field of plastic surgery. Many studies called for inclusion of the risk of ALCL in the consent gathering before surgery. However, others have also argued that due to the rarity of ALCL and lack of proven causality, it does not warrant mentioning the risk of ALCL during the consent gathering phase.  

ALCL is a rare condition. However, different studies report a wide range of different rates and such inconsistent reports can be confusing to a clinician. Just how rare is ALCL? And what is the real risk of ALCL in patients who receive breast augmentation using implants?

 

Etiology of BIA-ALCL

 

Pittman et al. explained there have been at least 193 cases of BIA ALCL worldwide (Anaplastic Large Cell Lymphoma: Emerging Consent and Management Patterns among American and International Board Certified Plastic Surgeons, Pittman, Troy A.; Fan, Kenneth L.; Rudolph, Megan A. Plastic & Reconstructive Surgery. 138(5):811e-818e, November 2016). Others have reported that there have been 173 cases.

In 2008, de Jong et al. reported that the prevalence of BIA-ALCL is only 1 out of 1 million based on a Dutch database. However, in a more recent study, they reported that the prevalence is one out of 30,000 (de Jong D, Vasmel WL, de Boer JP, et al. Anaplastic large cell lymphoma in women with breast implants. JAMA 2008;300:2030~2035).

Doren et al. examined the data base for ALCL from 1996 to 2015 and found that it occurred only with textured shell implants at the annual incidence of 2.03 out of 1 million. This is 67.6 times higher than the incidence of primary ALCL in normal breasts. The lifetime prevalence was 33 out of 1 million (U.S. Epidemiology of Breast Implant Associated Anaplastic Large Cell Lymphoma: Doren, Erin L. M.D.; Miranda, Roberto N. M.D. Plastic & Reconstructive Surgery: May 2017 – Volume 139 – Issue 5 – p 1042~1050).

 

HELIOSⅡ/LOTUSⅡ/HYPERION – Manufacturer: LASEROPTEK(www.laseroptek.com)

 

Such a large discrepancy in terms of incidence and prevalence of BIA-ALCL in literature is very confusing. However, there is a trend toward later studies reporting higher rates of BIA-ALCL. I wonder if previous studies have failed to recognize important cases. It is possible that with more attention being given to BIA-ALCL recently, more cases are being recognized. Despite the growing interest in BIA-ALCL, its risk may still be underestimated.

Pitman et al. emphasized that BIA-ALCL tends to be underreported and cited a report by Brody et al. on 23.7% of BIA-ALCL being underreported.

Most plastic surgeons are still not mentioning the risk of BIA-ALCL to their patients and it is not included in the informed consent form either.  

 

FDA announcement

 

In March 2017, FDA made an announcement on the significantly higher association between ALCL and breast augmentation using textured shell implants as opposed to smooth shell implants. CNN was quick to report this with a very eye-catching headline.

 

 

In August 2017, FDA updated the announcement based on collaboration with other agencies and a more extensive literature review.  

WHO recognized BIA-ALCL as a rare T-cell lymphoma occurring after breast implant placement.

FDA received medical device reports of 359 cases, 9 of which ended in death. Only 231 cases included the type of implant used and 203 cases had textured shell implants and 28 smooth shell implants.

 

-To be continued