Case guide
Had implants or tissue expanders after breast cancer care? Keep each device record.
Updated Oct 4, 202613 sources
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Updated Oct 4, 202613 sources
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U.S. Food and Drug Administration · Federal medical-device safety agency
Finding: FDA requested the BIOCELL recall because of BIA-ALCL risk. It did not recommend routine removal in patients without symptoms because of surgical risks.
FDA recall request, July 24, 2019 (opens in a new tab) · Jul 24, 2019 · Checked Oct 3, 2026
Leda Dunn Wettre · United States District Court for the District of New Jersey · United States Magistrate Judge
Finding: The July 14, 2026 order set pretrial deadlines for the Henson and Rabin cases. It did not set an individual award.
Case Management Order 42 (opens in a new tab) · Jul 14, 2026 · Checked Oct 3, 2026
U.S. Food and Drug Administration · 2019
Read the source: FDA BIOCELL recall safety review (opens in a new tab) · Checked Oct 3, 2026
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Had implants or tissue expanders after breast cancer care? Keep each device record. Breast cancer and BIA-ALCL are different diagnoses with different questions.
No. BIA-ALCL is a cancer of the immune system. A breast-cancer history does not confirm it.
Keep the original diagnosis beside any later findings near an implant. The care team can explain which disease a report names. Do not merge the diagnoses on a legal form.
Some implants and tissue expanders were recalled. Others were not. Ask the surgeon to check your model and style.
FDA’s July 2019 release lists Natrelle 133 and 133 Plus expanders along with recalled implant lines. The company notice supplies styles. Ask the surgeon which device was used at each step of reconstruction.
An expander and a later implant are not the same device. An expander is meant for short-term use. Keep the dates and model for each.
FDA says information about risk from temporary exposure to these expanders is limited. Do not replace that uncertainty with an assumption that all expanders had the same risk. Keep the original placement and replacement notes.
Tell your clinician about lasting swelling, pain or a lump. Ask what assessment is needed. Do not wait for a legal reply to seek care.
FDA describes exams, scans and fluid or tissue testing for suspected lymphoma. A new change is not automatically another breast-cancer diagnosis. Let the care team interpret it with your earlier history.
No payment rule follows from these sources. A lawyer needs the actual device and harm records. Ask which claim the facts support.
The July 2026 order concerns pretrial work for named cases, not a payment class for all reconstruction patients. Do not treat the reason for implant surgery as an automatic damages category.
Ask for the device card and notes for each surgery. Explain which procedure’s record is missing. Keep each diagnosis and implant date separate.
A caregiver should ask what authority or consent is needed to obtain someone else’s records. Request the complete device history you are entitled to receive. Keep uncertainty visible rather than assigning a recalled style yourself.
The review is free and private. Asking for it doesn’t commit you to anything.
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