Patient safety
What you are entitled to know, what your device records should tell you, and how to report a problem so it counts.
When to seek care urgently
Contact a physician promptly, or attend an emergency department, if you develop any of the following — whether you still have implants or have had them removed:
- Fever, spreading redness, or heat over the breast
- Sudden or one-sided swelling, or swelling that appears long after surgery
- A new lump or mass in the breast or armpit
- Pain that is worsening rather than easing
- Difficulty breathing, or chest pain
Late swelling around an implant is specifically worth having looked at, because it is the presentation associated with BIA-ALCL and is straightforward to investigate.
What the FDA requires
Since October 2021, breast implants sold in the United States must carry a boxed warning stating that they are not lifetime devices and that complication risk increases over time. Sale is restricted to providers who review a standardised patient decision checklist with the patient, which the patient and surgeon both sign.
If you had implants placed after that date, that signed checklist should exist. If you were never walked through one, that is worth knowing. You are entitled to ask for a copy of your records.
Know your device
Implants are medical devices with manufacturers, model numbers and lot numbers, and your surgical records should identify yours. This matters for three reasons: some models have been recalled, texture type is relevant to BIA-ALCL risk, and manufacturer warranties sometimes cover replacement or removal after rupture.
Ask your original surgeon’s office for your operative report and device stickers. If the practice has closed, the hospital or surgical facility where the operation took place usually retains records. In the United States, device recalls and safety communications are published by the FDA; in Canada, by Health Canada.
Reporting a problem
If you have had a complication, reporting it adds to the data regulators use. Under-reporting is a known problem in this area, and individual reports genuinely accumulate into evidence.
- United States:report to the FDA through MedWatch. Patients can file directly — you do not need a doctor to do it for you.
- Canada:report to Health Canada’s medical device problem reporting programme.
- United Kingdom: report to the MHRA through the Yellow Card scheme.
Include your device manufacturer, model and lot number if you have them, and the date of implantation.
Screening if you still have implants
Silicone implant rupture is frequently silent, meaning it produces no symptoms. The FDA recommends periodic imaging to screen for rupture in people with silicone implants, using MRI or ultrasound. Screening intervals and the preferred modality are matters for your physician.
Also tell any radiographer performing a mammogram that you have implants, as additional views are used to image the breast tissue around them.
Questions worth asking any surgeon
- Are you board certified, and in what specialty? Where can I verify that?
- How many explant procedures did you perform in the last year?
- What is your complication rate, and how do you track it?
- Will the capsule be sent for pathology?
- What would change your plan once you are operating?
- What does the quoted price include, and what happens if revision is needed?
- Where will the surgery take place, and is that facility accredited?
A surgeon who welcomes these questions is telling you something useful. So is one who does not.
- U.S. Food and Drug Administration. Breast implant labelling recommendations, boxed warning and patient decision checklist, October 2021.
- U.S. Food and Drug Administration. Medical device reports of systemic symptoms in women with breast implants; breast implant safety communications.