FDA Warns: Increased Risk of Large Cell Lymphoma After Breast Implantation

The FDA warns of a higher risk of developing large cell lymphoma in women who have breast implants compared to those who have not undergone breast implant surgery. On March 21, 2017, a corresponding warning was published on the official website of the FDA.

As of February 1 this year, the Office received 359 medical reports of large cell lymphoma (BIA-ALCL) in patients who had previously had breast implant surgery. Including 9 cases with a fatal outcome were recorded.

Implant characteristics in the development of large cell lymphoma ALCL

A link between ALCL, which is identified as a rare T-cell lymphoma, and breast implantation was first discovered in 2011. But, due to insufficient information, including clinical cases, risk factors cannot be determined. In subsequent years, a much larger number of cases were analyzed, as a result of which an increased risk of developing large cell lymphoma after breast implantation was confirmed.

Data show that BIA-ALCL lymphoma occurs more frequently after textured implants.

Analysis of 231 reports containing information about the surface of implants revealed that the surface of implants was textured in 203 cases, and only in 28 – smooth. Regarding implant fillers, the data are as follows: in 186 cases, the implants were filled with silicone gel, and in 126 – saline solution.

Advice for Doctors on Monitoring BIA-ALCL Large Cell Lymphoma

The FDA has also published current guidance for clinicians on what to do in this situation:

1. Continue to provide regular care for patients after breast implantation. Warn your patients that large cell lymphoma ALCL is rare, and if patients do not have symptoms such as pain, breast lumps, asymmetry, or other signs of pathological changes, there is no need to remove implants;
2. Patients who wish to have a breast implant should be provided with all necessary information about the implants prior to the operation, as well as a discussion of the possible risks and benefits of the operation. It is also important to draw the patient's attention to the fact that large cell lymphoma BIA-ALCL occurred more often in patients with textured breast implants;
3. if the patient has a late persistent peri-implantation seroma or capsular contracture – this may indicate a risk of developing BIA-ALCL lymphoma. In this case, the patient should be sent for additional examination to the appropriate specialist. In case of diagnosis of large cell lymphoma – it is necessary to develop an individual treatment plan, together with a team of doctors for multidisciplinary care;
4. All confirmed cases of BIA-ALCL large cell lymphoma in breast implant patients should be reported to the FDA.

Source: www.fda.gov