Prospective Evidence Links Textured Breast Implants to Rare Lymphoma

The risk of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) may be higher than previously reported for women who received textured breast implants, concluded a prospective study that sought to describe the complications women experience after breast reconstruction. The findings were reported at the 2019 American Society of Clinical Oncology (ASCO) Annual Meeting.¹

The prospectively enrolled cohort included 3546 women who underwent breast reconstruction with textured breast implants between 1993 and 2017; all of these patients underwent operations by the same surgeon. The women collectively had a total of 6023 breast implants inserted and complications that arose after reconstruction were prospectively recorded.

Median patient age at the time of surgery was 48 years (range, 18–89 years). Most patients had bilateral reconstruction (69.9%) and reconstruction was performed after mastectomy (96.7%). Nearly all patients received Biocell (Allergan) textured implants (96.7%). Patients were followed for a median of 7 years (range, 3 days–24.7 years).

In total, 8 women were eventually diagnosed with ALCL after being exposed to the textured breast implant for a median of 11.2 years (range, 8.3–15.8 years), which translated to an incidence rate of 1 case per 433 women. The risk was 0.294 cases of BIA-ALCL per 1000 person-years in the study cohort. All 8 cases received Biocell textured implants.

Biocell is a textured breast implant marketed by Allergan, and the product has been recalled by dozens of countries, but is still being sold in the United States.²

“In this cohort the risk of BIA-ALCL with textured breast implants is higher than previously reported,” wrote the study authors. Retrospective studies have estimated as low as 1 case per 6920 women who received implants.³ The study authors also suggested that the “incidence may increase with longer follow-up.”

References

1. Ghione P, Cordeiro PG, Ni A, et al. Risk of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) in a cohort of 3,546 women prospectively followed after receiving textured breast implants. Poster presented at: 2019 American Society of Clinical Oncology (ASCO) Annual Meeting; May 31-June 4, 2019; Chicago, IL. Abstract 1565.
2. US Food and Drug Administration. Statement from FDA Principal Deputy Commissioner Amy Abernethy, MD, PhD, and Jeff Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health on FDA’s new efforts to protect women’s health and help to ensure the safety of breast implants. Published May 2, 2019. Accessed June 26, 2019.
3. de Boer M, van Leeuwen FE, Hauptmann M, et al. Breast implants and the risk of anaplastic large-cell lymphoma in the breast. JAMA Oncol. 2018;4(3):335-341.