Law Offices of Thomas J. Lamb

  • About Firm
  • Practice Areas
  • Free Case Evaluation
  • Quick Contact Form
  • Frequently Asked Questions
  • Attorney Tom Lamb

Black Box Warning Label Change for Breast Implants Finalized by the FDA

October 23, 2020 By Law Offices of Thomas J. Lamb, P.A.

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

Free Breast Implants Case Evaluation

Filed Under: Unsafe Medical Devices Tagged With: allergan breast implants, breast implant-associated anaplastic large cell lymphoma, breast implants, breast implants BIA-ALCL, breast implants lymphoma cancers, medical devices adverse effects, textured breast implants

Find What You Want Here

Get Free Case Evaluation

We encourage you to submit an online Case Evaluation Form – it is confidential and there is no obligation.

Or call our toll-free number, 800-426-9535, to speak directly to attorney Tom Lamb about your possible case.

Feel Free To Contact Us

Quick Contact Form
 
Send an Email to Tom Lamb

(800) 426-9535

Main Navigation Menu

  • About Firm
  • Asbestos-Mesothelioma Cases
  • Benzene Disease Claims
  • Drug Injury Lawsuits
  • Breast Implant Cancer Cases
  • Case Evaluation Menu
  • Quick Contact Form
  • Frequently Asked Questions
  • Medical Records Charges
  • Collection of Articles
  • Sitemap

Lamb Law Office Newsletter

Lamb Law Office Newsletter provides periodic updates about some of the cases that we are working on for clients, as well as an information resource you might find helpful.

Subscribe using Form below.

Subscription Form

* indicates required

Our Other Websites

DrugInjuryLaw.com

DrugInjuryWatch.com

Asbestos-Mesothelioma.com

Contact Information

Law Offices of Thomas J. Lamb, P.A.
1908 Eastwood Road, Suite 225
Wilmington, North Carolina 28403
910-256-2971 | 800-426-9535
TJL@LambLawOffice.com

  • Home
  • Disclaimer and Copyright Notices
  • Sitemap

Copyright © 2025 · Law Offices of Thomas J. Lamb, P.A.