What Does the MHRA/FDA Say About Breast Implant Safety?

If you are trying to understand breast implant safety, you may come across the MHRA and FDA. The MHRA monitors medical device safety in the UK, including breast implants. The FDA are based in the US.

Breast implants are medical devices, so safety monitoring, reporting, and public guidance are important.

This article explains the MHRA / FDA role in plain English and why it may matter to you if you have implants or are thinking about them.

What does the MHRA/FDA do?

Each country has its own government department that monitors the safety of medical devices used.

If you use Google or a similar search engine you will be able to find the department that oversees the reporting of complications with breast implants in your country,

For breast implants, this can include reviewing safety reports, monitoring possible risks, publishing information, and working with expert groups.

These departments do not replace your GP, PCP, family doctor, surgeon, clinic, or breast unit. But they can be an important source of public safety information.

Why does this matter for patients?

When you have a medical device in your body, you should be able to access clear information about safety concerns, reporting systems, and what to do if something changes.

Regulation can feel abstract until you need it. But it becomes very practical when you are trying to understand:

• What implant you have
• Whether there are known safety concerns
• How to report a problem
• What symptoms should be checked
• How your implant details are recorded

What is the Yellow Card Scheme and Reporting Adverse Event System?

The Yellow Card Scheme and adverse event reporting system allows patients and healthcare professionals to report suspected problems with medicines and medical devices, including breast implants.

A report does not prove that an implant caused a symptom. But reports help regulators look for patterns and monitor safety.

If you believe you have had a problem with a breast implant, you can ask a clinician about reporting it or report it yourself through the Yellow Card Scheme or if you Google your country and report adverse effects of breast implants the information on how to report will be easily found.

What is the Breast and Cosmetic Implant Registry?

The Breast and Cosmetic Implant Registry records details of breast implant surgery in each country globally. Each country manages their own register and you can find the details of the register for your country. 

The surgeon will submit your implant details at the time of surgery. 

If you want to check that the implants are registered, ask your GP, PCP, family doctor, the surgeon or clinic and they will give you the registration details. However, It is your surgeons responsibility to register your implants so please ask the surgeon if the implant details have been submitted. 

One purpose is to help trace patients if there is a safety concern about a specific implant type. 

If you are having surgery, ask whether your details will be recorded and whether you will receive a copy of your implant information.

If you already have implants and do not know the details, you can ask your clinic, hospital, or surgeon for your records. 

What does the MHRA/FDA say about BIA-ALCL?

The MHRA publishes information about breast implant-associated anaplastic large cell lymphoma, often shortened to BIA-ALCL.

BIA-ALCL is an uncommon lymphoma associated with breast implants. It is not breast cancer, but it can develop in the scar tissue capsule or seroma around an implant.

Current guidance does not generally advise implant removal for people with no symptoms solely because of BIA-ALCL concerns. However, people with unexpected changes in breast size, shape, or feel should seek medical advice.

What symptoms should be checked?

If you have implants, ask for medical advice if you notice:

• Unexpected swelling
• A change in breast size
• A change in breast shape
• New pain
• A lump
• Fluid around the implant
• Skin changes
• A change in how the breast feels
• Itchy skin with a rash 
• Discolouration of the breast 
• Swelling that comes and goes 

These symptoms do not automatically mean something serious is happening. But they are worth checking.

What records should you keep?

It is useful to keep:

• Operation date
• Clinic or hospital name
• Surgeon name
• Implant manufacturer
• Implant type, size, surface, and serial or lot number if available
• Follow-up letters
• Imaging or test results
• Any reports made about symptoms or complications

Keeping records is not about expecting something to go wrong. It is about making future care easier if you ever need it.

What if something feels wrong?

If you have unexpected pain, swelling, burning, changes in skin colour, or changes in breast shape or size, contact the clinic where you had surgery, your GP, or an appropriate breast service.

If symptoms feel urgent, seek urgent medical care.

Final thought

The MHRA and FDA and other countries government office for medical devices role can feel technical, but the practical message is straightforward:

• Keep your implant records.
• Report concerns where appropriate.
• Ask for medical review if something changes.
• Use reliable sources rather than trying to piece together answers from frightening online posts.

You do not need to understand every regulatory detail to take your concerns seriously.

CTA

Read our Independence Statement and Content Standards to understand how Legacy uses public safety information responsibly.

Content & Article IP © Lisa Doran 2026