how do you report to the FDA?
Please report any breast implant symptoms or adverse reactions by reporting it to your government agency. Reports can be made by anybody (patients, doctors, surgeons, healthcare providers) using the online portal system on the MedWatch Online Voluntary Reporting Form. We suggest making the report yourself to make sure it is completed correctly. If you wish to see submitted medical device reports to the FDA you can find that information in the Manufacturer and User Device Experience Database.
The FDA finally updated their website on October 23, 2019 and made BII official. After numerous reports were submitted, they officially listed breast implant illness as a risk associated with breast implants. This is a great start for all women suffering from BII. Please start making your report today by following the information below. The more evidence the FDA has from more reports, the bigger the impact it will have for sufferes of BII. It will eventually help get the coverage we need from all insurance companies and for those without insurance.
Non-U.S. Countries Report Links
Australia: TGA Report
Canada: Health Product Complaint Form
UK: Report a problem with a medical device
- Wales: NHS Report
- Scotland: FHS Report
- Northern Ireland: Department of Health
Health Insurance Guide to your breast implants
A lot of insurance companies are starting to realize that the removal of breast implants is medically necessary and have begun to cover implant removal surgery- explant. Make sure you go over your insurance policy first and see if they will possibly pay for removal. Make sure your doctor knows of all your breast symptoms and complaints. If you are experiencing pain you must tell your doctor how this is pain is intolerable and how it is affecting your life. The typical insurance coverage is for those individuals with chronic breast pain, ruptures, infections, and capsular contracture. Make sure you use the correct insurance codes (below) when filling out a Medical Necessity letter to send to your insurance company. If you need private insurance help by the National Center for Health Research click here.
As a precaution for filing for insurance, you must know that some women have had to apply multiple times before getting insurance approval. It is in your best interest to be persistent and not give up easily. You can file a complaint with the state insurance commissioner if you have exhausted the appeals procedure. If nothing else works, you can retain an attorney. Have your attorney send your insurance company a letter for failure to cover a medically necessary procedure.
If you need help with letters or how to get insurance to cover your explant click here. These Google drive documents on the link will give you the steps on how a woman was able to get coverage for explant.
Insurance Codes
CPT
19371-50 – Periprosthetic capsulectomy, breast – the 50 modifier is for – Bilateral Procedure
ICD 10
N64.81 – Breast Ptosis
N64.4 – Mastodynia – pain in the breast
T85.49XA – Other mechanical complication of breast prosthesis and implant, initial encounter
T85.79XA – Infection and inflammatory reaction due to other internal prosthetic devices, implants and grafts
T85.848A – Pain due to internal prosthetic devices, implants and grafts
T85.44XA – Contracture of Breast Prosthesis
T85.43XA – Rupture of Breast Prosthesis