Breast implant-lymphoma link probed by EC committee

Regulatory NewsRegulatory News | 23 October 2020 |  By 

The European Commission (EC) is seeking public consultation on a new preliminary opinion on the potential association between breast implants and a type of lymphoma, with comments due by 7 December 2020.
The EC’s Scientific Committee on Health, Environmental and Emerging Risks (SCHEER) issued on report on the relationship between breast implants and anaplastic large cell lymphoma (BIA-ALCL). The committee’s charge encompassed use of implants both for breast reconstruction and for augmentation.
In the preliminary opinion, SCHEER found “a moderate level of evidence” that textured breast implants can cause ALCL, though it acknowledged that the pathogenesis is not well understood.  In the SCHEER schema of quality of evidence, this means that there is good evidence from a primary line of evidence, but important gaps in the data are still present.
The committee listed a variety of hypotheses that are in play, ranging from genetic predisposition to inflammation resulting from bacterial contamination to particulates and reactive compounds shed from the implants. “At the time of writing this report, there is insufficient scientific evidence available to rule out any of these potential mechanisms of disease pathogenesis,” said the committee.
Textured implants became popular because they prevent rotation and shifting of breast implants and may also reduce the risk of post-implant capsular contraction. There are several methods of manufacturing textured implants, and surface smoothness or roughness varies among implants on the market.
Some of the difficulty in sorting through the potential association, said SCHEER, is that while ALCL may occur just a few years after an implant is placed, some literature indicates the latency can stretch past two decades. Further, the committee noted that the quality of literature in this area is variable, with ad hoc reporting and sales data among the data sources used.
Still, the committee’s preliminary opinion noted that although the overall occurrence of BIA-ALCL is rare, regulators have seen a steady increase in the number of cases being reported, with textured, but not smooth implants implicated. “The most important criterion that is associated with the occurrence of BIA-ALCL is the type of surface characterizing the implant. Although the full etiology is not yet understood, an appropriate control measure to reduce the identified risk is to limit the use of textured implants,” said SCHEER.

Remedies recommended by SCHEER include establishing mandatory breast implant registries that incorporate a harmonized reporting dataset. The dataset should include the device Unique Device Identification (UDI) or serial number “to provide structured denominator data for risk calculations.”
A universal grading system for implant surface characteristics would also be useful, and more research should focus on whether surface roughness contributes to shedding and tissue irritation, with resultant increased ALCL risk.
Similarly, BIA-ALCL could better be detected if breast surgery and pathology registries were structured to achieve surveillance for the condition. Individual genetic characteristics that may contribute cancer risk should also be explored.


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Tags: devices, EU, medical

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