29 November 2018

The Risks of Implant-Associated Large Cell Anaplastic Lymphoma

The Risks of Implant-Associated Large Cell Anaplastic Lymphoma

COMMUNIQUE FROM THE RBSPS (Belgian Royal Society of Plastic Surgery) :

Anaplastic Large Cell Anaplastic Lymphoma Associated with Breast Implants (BIA-ALCL) is an extremely rare lymphoma that can occur around breast implants - and if detected early, it is curable in most patients.

BIA-ALCL is not a breast tissue cancer per se. All government authorities and oncology societies classify BIA-ALCL as a lymphoma, a group of blood cancers that develop from lymphocytes (a type of white blood cell). BIA-ALCL has been known for some time (the first case was reported in 1997). Episodically the subject is discussed in the media, often interested in plastic surgery. The RBSPS wishes to take its responsibilities and correctly inform patients about BIA-ALCL, how to diagnose and treat it.

The most frequent sign of this disease is a late seroma (swelling of the breast) inside the periprosthetic capsule. The average time until the appearance of the first symptom can be estimated to be 8 years (range 1 to 28 years) from the time of breast implant insertion. However, the late seroma is not a direct precursor of BIA-ALCL, but all late seromas should be thoroughly investigated by fine-needle puncture cytology with examination using a specific marker.
The prognosis is generally favourable for localization in pericapsular tissue, and most patients are treated by simple removal of the implant and capsule. In a minority of cases, chemotherapy or radiotherapy may be necessary, but these adjuvant treatments are only indicated for more advanced disease, related to late diagnosis.

Concrete evidence from peer-reviewed scientific publications to date does not support any statistically significant association between the development of BIA-ALCL and any implant/patient/surgery related feature. In 2017, the FDA received a total of 359 medical reports of BIA-ALCL: 231 of these reports included information regarding the implant surface. Of these, 203 involved textured implants and 28 involved smooth implants. In addition, 312 of the 359 cases contained information on filled implants. Of these, 186 involved silicone gel-filled implants and 126 involved saline-filled implants. The implants had been used in both reconstructive and cosmetic breast surgery.
Bacteriological contamination, long-term inflammation, implant shell texture, and genetic factors have been theorized and are being further investigated as possible causes of BIA-ALCL. Research is ongoing and cases have been analysed for years. As with other cancers, genetic predisposition may play a role. The concentrations of reported cases vary widely around the world, with some geographical areas reporting very limited numbers of cases.

In terms of incidence, only very refined values have been estimated to date. Some authors have estimated the risk to be 1 in 500,000 to 3 million women with implants. Others have estimated the incidence in the United States based on a review of the literature and institutional databases of BIA-ALCL cases to be 2.03 per million person/years; in December 2016, the Australian Government's Therapeutic Goods Administration reported an incidence rate in the range of 1 in 1000 to 1 in 10,000 for patients with textured implants. The incidence rate is the result of dividing the new cases that appeared during a given period of time into the population at risk during the same period.

Up to November 2017, over a period of more than 20 years, approximately 460 cases have been reported worldwide, including 16 disease-related deaths. Although the incidence is therefore extremely rare, RBSPS believes that as physicians, we must consider any therapy or procedure that may pose a danger to the patient as a major concern and something that patients should be informed about before undergoing breast implant surgery. They must be made aware of this risk, of the risks of the surgery itself, and of the possible additional financial costs.

Based on a recent analysis of the relative risk of death, a woman's risk of death is twice as high for a day of skiing as for a lifetime with a textured breast implant, 2.5 times higher for drinking two glasses of wine than for a lifetime with a textured breast implant, and 40 times higher for driving for eight hours than for a lifetime with a textured breast implant. These data are not intended to minimize the risk of BIA-ALCL, but simply to provide a perspective for the patients involved.
While the risk is minimal, patient safety is a primary goal in our society and we are working hard to educate and inform our members and the public about the symptoms and any risk of BIA-ALCL.
To our knowledge, we have identified four cases of BIA-ALCL and all of these cases have been correctly diagnosed and treated with a favourable outcome.

Based on the literature, RBSPS is of the opinion that asymptomatic women with no changes in their breasts require nothing more than routine follow-up. If a patient sees a change in her breasts - particularly if there is swelling or swelling - she should undergo appropriate examinations and imaging, including ultrasound, and fine needle puncture of any periprosthetic fluid.

Thorough patient education about BIA-ALCL is critical when considering breast implant surgery, and it is reasonable to include BIA-ALCL as a potential complication of breast implant placement in both cosmetic surgery and post-mastectomy reconstructive surgery.

For the Belgian Royal Society of Plastic Surgery (RBSPS)


Prof. Moustapha Hamdi
President of the RBSPS