Breast Implant Safety Update from the U.S. FDA
The U.S. Food and Drug Administration (FDA) recently updated its safety requirements for breast implants. On 27 October 2021, the FDA announced several actions to assist prospective breast implant patients in making a well informed decision. These actions cover many aspects of and parties to the breast implant industry including manufacturers, distributors, surgeons and even the patients themselves. The major changes are required actions relative to product information and risk disclosure. Manufacturers, distributors and surgeons have been given 30 days to implement the proposed changes into their business practices and in the case of the manufacturers and distributors, to upload the required information to their websites.
The actions proposed by the FDA are as follows:
One of the actions proposed by the FDA includes restricting the sale and distribution of breast implants to health care providers and facilities who have implemented the appropriate use of the “Patient Decision Checklist”. This “Patient Decision Checklist” has been designed and reviewed by the FDA to ensure that patients are fully aware not only of the benefits associated with breast implant surgery but also of all the risks as well.
The other major action is to require improved labelling on breast implants as well more comprehensive device information. This information on both on the box and the packaging for breast implants includes:
- A Warning on the Box
- The “Patient Decision Checklist”
- Updated Screening Recommendations for Potential Rupture of Silicone Gel-Filled Breast Implants
- A Description of the Implant Including the Materials in the Device
- Patient Device Card
The greatest change, however, to the patient consultation experience will probably be the implementation of the “Patient Decision Checklist”. The medical practitioner must not just give this information to the patient to review at their leisure but must go through the checklist with the patient during consultation to ensure patient awareness. The surgeon must sign the checklist and the patient must be given the opportunity to sign and/or initial the checklist themself. This procedure if appropriately applied and monitored will ensure that there is a uniformity in the way that patients are made aware of risks as well as benefits. How successfully this will be implemented or enforced has yet to be seen.
“Legally Marketed Breast Implants”
Interestingly, the new labeling recommendations by the FDA are for “all legally marketed breast implants”. This brings into question what is being done about non-approved devices and the risk that they pose to the public. The “legally marketed” breast implants specifically noted by the FDA include the following:
- IDEAL IMPLANT Structured Saline Breast Implants
- Mentor Saline-Filled and Spectrum Breast Implants
- Inamed (now Allergan) Natrelle Saline Filled Breast Implants
- Inamed (now Allergan) Natrelle Silicone Filled Breast Implants
- Mentor MemoryShape Silicone Gel-Filled Breast Implants
- Mentor MemoryGel Silicone Gel-Filled Breast Implants
- Sientra OPUS Silicone Gel Breast Implants
To read more on the FDA recommendations you can click on the following links:
In Australia, the government agency with authority over the approval and use of medical devices is the Therapeutic Goods Administration. You can find their information on breast implants and breast implant safety on their Breast Implant Hub.