BIA-ALCL and Textured Breast Implants: A Systematic Review of Evidence Supporting Surgical Risk Management Strategies

Abstract

reast implant-associated anaplastic large cell lymphoma (BIA-ALCL) is a significant public health concern impacting millions of women with textured implants. A decade ago, the risk for developing BIA-ALCL was thought to be as low as 0.1-0.3 per 100,000 patient years; however, current estimates indicate that the incidence of BIA-ALCL may be much higher. [1][2][3] Two recent analyses from a large cohort of patients with long-term follow-up at our institution suggest that the risk for BIA-ALCL may be as high as 1 in 559 women, with an average time to diagnosis of 10 years. 2,3 Notably, a time-to-event analysis suggests that the risk of developing BIA-ALCL increases over time. 2 This is particularly alarming to the thousands of women with textured implants who have yet to approach this 10-year mark. 1 The rising incidence of BIA-ALCL has increased awareness of an association between textured implants and the development of the disease. In July 2019, the US Food and Drug Administration (FDA) issued a recall of all Allergan Natrelle BIOCELL-textured breast implants, often classified as macrotextured devices. 4,5 Although these devices may no longer be used for reconstructive or aesthetic breast surgery, developing a management strategy for asymptomatic patients with textured implants who fear they may be at risk

AGO Recommendations for the Diagnosis and Treatment of Patients with Early Breast Cancer: Update 2022

“…Table 5. DCIS, upstaging, ipsi-/contralateral events and mortality [42,43] Upstaging to BC Ipsilateral events (cum. incidence), % Contralateral events (cum.…”

“…Surgical excision is the recommended treatment. For patients with advanced and disseminated diseases, the treatment did not differ from other types of T-cell lymphoma [43].…”

BIA-ALCL-Horizon Scanning

“…Whilst there is no doubt that BIA-ALCL is almost exclusively associated with textured-surface implants, there is some ambiguity regarding whether any pure smooth cases have been identified, and it would be impossible to exclude this as a possibility. 20 However, given the overwhelming preponderance of texture, many attempts have been made to try and understand this relationship better. In particular, attempts have been made to quantify risk according to the degree of texturization.…”

Advances in Biomaterials for Breast Reconstruction

“…If BIA-ALCL is localized to the capsule only, it may be treated with surgery; however, in advanced cases, including lymph node involvement, surgery and chemotherapy or radiotherapy are indicated for treatment. To reduce the risk of developing BIA-ALCL, removing textured devices with subsequent closure, exchange for a smooth implant, or conversion to autologous reconstruction could be options [68]. Consequently, in clinics there is a tendency worldwide for surgeons and patients to alter their implant choices from textured to smooth-surface implants [69].…”