Since our previous article, “New BIA-ALCL Cases Identified in Updated FDA Report“, the FDA has finalized labeling guidance for breast implant manufacturers. The FDA label change is now requiring a black box label warning for the breast implant devices. In recent years, many textured breast implants have been linked to BIA-ALCL (breast implant-associated anaplastic large cell lymphoma).
What the Label Change Covers
According to a September 2020 MedTechDive article, the FDA’s breast implant label guidance addressed concerns that some patients are not receiving or understanding the risks associated with these devices. In a boxed warning example provided, the FDA states breast implant devices are not meant to be lifetime devices. This is potentially due to the chance of developing complications with the device increasing the longer people have them.
The same article cites several systemic symptoms to keep an eye out for. These include joint pain, muscle aches, confusion, chronic fatigue and autoimmune diseases. The article then goes into further detail of what the FDA guidance encompasses:
In addition, the guidance advises that patients should receive a decision checklist and information brochure highlighting the risks of BIA-ALCL, systemic symptoms, surgical risk, situations in which the devices should not be used, considerations for a successful implant candidate, and a discussion of options other than the breast implants.
FDA recommends that current estimated incidence rates of BIA-ALCL be included in the patient decision checklist, both overall figures and specific rates for the manufacturer’s product, based on published literature, registries and medical device reports. Manufacturers are told to explain in the checklist the methodology used in determining the incidence rates.
FDA updated rupture screening recommendations to follow the consensus advice of its expert panel for screening to begin between years five and six after surgery and then repeat every two to three years. Ultrasound was recommended as an acceptable alternative for screening asymptomatic patients.
Patient Device Cards
Additionally, the FDA is currently recommending physicians provide their patients with a “device card” post-surgery. According to a September 2020 article, “Breast implant label guidance finalized by FDA“, the device card will contain various relevant information, including:
To clarify the patient device card, FDA recommends including language stating that “This card belongs to the patient. Please give it to the patient” so that the physician can do so immediately after implantation. Specifics including serial number, lot number, device style, device size and unique device identifier (UDI) also should be included. The addition of web links to provide the most up-to-date access to the patient device checklist, boxed warning and labeling of the specific implant also should be included.
As always, we will continue to monitor the worldwide issues surrounding breast implants and BIA-ALCL. We will provide you with any new or relevant information.
We encourage you to visit our Breast Implants Lymphoma Cancer page on our website for more information. Please submit a free case evaluation if you or someone you know has been diagnosed with BIA-ALCL.
Written by: Lauren Schwab, Legal Assistant
Law Offices of Thomas J. Lamb, P.A.
Breast Implants: Lymphoma / Blood Cancer Cases Overview