This article deals with the reports of squamous cell carcinoma in the capsule around breast implants released by the U.S. Food and Drug Administration (FDA) on March 8, 2023. The Food and Drug Administration stated that occurrences of squamous cell carcinoma may be connected to breast implants. It noted that it has discovered 19 cases of the disease in the scar tissue around the implants in published research. The FDA 510k Consultant is asking health care providers and people with breast implants to report cases of SCC, lymphomas, or any other cancers around breast implants to the FDA and to collaborate with other regulatory authorities, scientific experts, breast implant manufacturers, and registries to gather all available information on cancers in the capsule around breast implants.
Recommendations for People
The FDA recommends the following :
- Find out more about the advantages and disadvantages of breast implants whether you have them or are thinking about getting them.
- Your regular medical treatment or follow-up appointments do not need to change if you have breast implants.
- While you still have breast implants, keep an eye on them. Consult with your surgeon or healthcare practitioner right away if you detect any changes in your breasts or implants.
- The FDA’s earlier guidelines on breast implant-associated anaplastic large cell lymphoma are still in effect and are not affected by these recommendations at this time (BIA-ALCL).
Recommendations for Health Care Providers
- When speaking with people who have breast implants or are thinking about getting them, mention SCC and different lymphomas that can develop in the capsule around the implant.
- Create an individualized treatment plan in collaboration with a multidisciplinary team of specialists, including surgical oncology, plastic surgery, breast surgery, radiology, oncology, and pathology, for patients who have been diagnosed with SCC or different lymphomas in the capsule surrounding the breast implant.
- The FDA should be notified of any occurrences of SCC, lymphomas, or any other tumors in the capsule around the breast implant. Adverse event reporting on time can assist the FDA in identifying and better comprehending the dangers connected to medical devices.
- For more detailed information, visit the source link given below.
FDA 510k Consultant help you navigate the complete process for Class I, Class II, and Class III devices by thoroughly understanding the device and by identifying any possible pitfalls. Qualified and experienced technical experts assure faster 510k clearance.
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Source : USFDA March 3, 2023
