How Do I File a Complaint to the FDA About Breast Implants Making Me Sick?

You wake up every morning feeling drained. Your joints ache, your chest feels heavy, and you’ve developed persistent brain fog that won’t go away—no matter how many tests you take, nothing seems conclusive. You’ve seen specialists, tried medications, and changed your diet, but nothing works. If you have breast implants and experience these symptoms, it’s possible that you may have Breast Implant Illness (BII).

If you’re experiencing symptoms that you believe are related to your breast implants, it’s important to take the next step and report it to the FDA—not only for your well-being but also for the safety of others. Dr. Shaher Khan at Executive Plastic Surgery is a national advocate for women affected by BII. As “the king of explants” and a staunch opponent of implant-based procedures, he encourages anyone affected to report their symptoms directly to the FDA.

In this article, we highlight the signs and symptoms indicating your breast implants may be making you sick and how you can report them directly to the FDA.

Signs indicating your breast implants are possibly making you sick

• Chronic fatigue that lingers despite rest
• Persistent joint and muscle pain without a clear cause
• Brain fog or memory problems
• Unexplained anxiety or depression
• Recurring chest pain or tightness
• Hair thinning or hair loss
• Rashes or unusual skin changes
• Dry eyes and mouth
• Symptoms of autoimmune disorders
• Sudden onset of food or chemical sensitivities
• Hormone imbalance symptoms
• Inflammation and swelling around the implant area

Why it’s crucial to report breast implants to the FDA

• Help uncover long-term risks that clinical trials may miss: Breast implants are approved based on studies involving a limited number of participants. When you report your adverse symptoms, you’re helping expose complications that weren’t visible in pre-market testing.
• Ensure other women don’t suffer in silence: By making your voice heard, you empower other women to come forward—many of whom suffer the symptoms of Breast Implant Illness in silence for years. Reports add up and prompt deeper investigations into the safety of these devices.
• Influence policy and future safety guidelines: FDA regulations are influenced by public reports. Your complaint may lead to updated warnings, recalls, or stricter approval standards for manufacturers.
• Create an official record of your symptoms: Filing a report puts your symptoms on record, which can support advocacy efforts and legal cases and help raise national awareness about Breast Implant Illness.

How to file a complaint to the FDA about breast implants making you sick

Step 1: Gather your medical information

Before submitting your report, compile your symptoms, medical history, and any relevant testing or diagnoses. Include the make, model, and type of breast implants you received, if possible.

Step 2: Visit the MedWatch online reporting portal

Go to the FDA’s MedWatch website. This is the official platform where consumers can report serious reactions or product problems related to medical devices, including breast implants.

Step 3: Select “Consumer/Patient” to begin

Once on the MedWatch page, click on “Report a Problem” and then select the option for consumers or patients. You don’t need to be a healthcare provider to submit a report.

Step 4: Fill out the form with as much detail as possible

You’ll be asked to provide information about the device, your symptoms, and any outcomes. Be thorough and honest—more details mean a more useful report for FDA investigators.

Step 5: Submit the report and keep a copy for your records

After submitting the form online, save a copy for your personal medical file. You may be contacted by the FDA for additional information if necessary.

Step 6: Inform your surgeon or explant specialist

Let your medical provider—preferably a Breast Implant Illness specialist like Dr. Khan—know that you’ve filed a report. He may also contribute his clinical notes to support your claim.

At Executive Plastic Surgery, we believe in restoring your health through safe, honest, and transparent care. Dr. Khan has made it his mission to remove implants—not place them—and he is known for “The Khan Procedure,” his signature en bloc explant technique that removes the entire implant along with the surrounding scar tissue.

If you believe your breast implants are making you sick, take action by filing a report with the FDA. It’s a critical step in protecting your health and advocating for others. And when you’re ready to explore your next step in healing, contact us to schedule a consultation.