Regulatory Focus™ > News Articles > 2019 > 2 > Swissmedic Updates on Breast Implant Associated-anaplastic Large Cell Lymphoma

Swissmedic Updates on Breast Implant Associated-anaplastic Large Cell Lymphoma

Posted 18 February 2019 | By Ana Mulero 

Swissmedic Updates on Breast Implant Associated-anaplastic Large Cell Lymphoma

Swissmedic said Monday that based on the currently available information, the association Swiss Plastic Surgery recommends using smooth implants rather than textured implants where permitted by the clinical situation.

France’s National Agency of Medicine and Health Products (ANSM) echoed that recommendation after observing most known breast implant associated-anaplastic large cell lymphoma (BIA-ALCL) cases in patients with textured breast implants. But the committee does not recommend preventive removal of textured implants.

The update forms part of regulators’ work to address a growing body of adverse event cases worldwide that have been linked to the use of breast implants, particularly as it relates to cases of BIA-ALCL.

A challenge with the review into known cases of BIA-ALCL relates to the current lack of controlled clinical trials for data that assesses the difference between smooth and textured breast implants among uniform groups of patients, Swissmedic noted. “There is thus no scientific evidence to date of a causal relationship between use of a specific breast implant and the development of BIA-ALCL,” Swissmedic added. “The cause of and mechanism by which BIA-ALCL develops have not been identified yet.”

Swissmedic also noted four other recommendations issued by the ANSM committee. These highlighted the need for a standardized classification of the different surfaces of breast implants, as well as “greater transparency on the part of the manufacturers and a guarantee of the quality and safety of their medical devices.” The remaining two recommendations called for providing detailed information to patients about breast implants, including on possible alternatives to textured implants and follow-up care, and systematically to relevant health care professions about the risks associated with breast implants.

The committee also argued that “it is necessary to prohibit the use of Allergan’s Biocell.” The textured breast implant was subjected to a recall last December amid patient safety concerns in Europe and Allergan subsequently suspended sales of Biocell and withdrew remaining supplies in European markets.

Use of breast implants have come under increased scrutiny. “In view of the growing awareness of the issue and the rising number of internationally confirmed cases of BIA-ALCL, Swissmedic advises individuals who are considering breast implants or who present for follow-up of their breast implants to discuss the risks and benefits of an intervention of this type with their surgeon as a matter of urgency.”

Swissmedic further noted that all cases of ALCL must be reported to a breast implant registry that Swiss Plastic Surgery intends to release in early 2019.

Swissmedic’s update follows on the heels of a letter the US Food and Drug Administration (FDA) sent to health care providers to raise awareness on additional cases of BIA-ALCL. FDA’s evaluation of medical device reports (MDRs) associated with BIA-ALCL found 246 new cases since 2017, totaling 660 MDRs.

Categories: Regulatory News

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