The US Food and Drug Administration (FDA) has announced changes to its regulations that strengthen safety requirements for breast implants.
The regulator has restricted the sale and distribution of breast implants to only health care providers and updated the labelling for all the FDA-approved breast implants.
The updated labelling includes a boxed warning and updated recommendations for screening of silicone gel-filled breast implant rupture.
It also includes a patient decision checklist, device description and patient device card, to ensure the patient understands the risks, benefits and other information about the device.
FDA said that the new measures will help patients understand the risks and benefits of breast implants and help them make informed decisions.
In addition to restrictions, the agency has unveiled updated information on the status of the post-approval studies conducted by breast implant manufacturers.
US FDA Centre for Devices and Radiological Health director Binita Ashar said: “Protecting patients’ health when they are treated with a medical device is our most important priority.
“In recent years, the FDA has sought more ways to increase patients’ access to clear and understandable information about the benefits and risks of breast implants.
“By strengthening the safety requirements for manufacturers, the FDA is working to close information gaps for anyone who may be considering breast implant surgery.
“As the FDA continues to evaluate the overall effects of breast implants in patients, today’s actions help ensure that all patients receive the information they need to make well-informed decisions affecting their long-term, personal health.”
The regulator has convened the General and Plastic Surgery Devices Advisory Panel in 2019 to assess the benefits and risks of breast implants for breast augmentation and reconstruction.
It covered various topics, including characterisation of breast implant-related anaplastic large cell lymphoma (BIA-ALCL), and methods for assessing breast implant illness.
The panel recommended the FDA to include a boxed warning in breast implant labelling and add a standardised checklist as part of the informed consent process.
Also, the panel suggested revision of MRI screening for silent ruptures of silicone gel-filled breast implants and transparency regarding materials used with breast implants.
FDA has ordered the breast implant manufacturers to display the updated device labelling on their websites within a period of 30 days.
