FDA uncovers additional types of cancer linked to breast implants

The Food and Drug Administration (FDA) has informed  the public in September 2022 about reports of new cases of cancers in the capsule that forms around breast implants. In some cases, people were diagnosed after years of having breast implants. Some of the reported signs and symptoms included swelling, pain, lumps or skin changes. 

The various lymphomas reported are not the same as Breast Implant-Associated Anaplastic Large Cell Lymphoma (also known as BIA-ALCL) which were reported in the past. It is important to note that these cancers are related to both textured and smooth implants, and appear in both Saline and Silicone breast implants.

Dr. Randall Feingold’s clinical experience with a case of BIA-SCC:

This NEWS is especially disturbing to me because I treated a young South American woman several years ago for a fluid collection around a silicone implant that was the symptom of Squamous Cell Carcinoma of her capsule. Her MRI did not reveal disease in any lymph nodes and I performed a precise total capsulectomy under the watchful eyes of a surgical oncologist. She then received radiation therapy. In spite of those efforts she developed metastatic disease in her lung requiring lung removal, and she still died. 

This predated the now-common awareness of BIA-ALCL, and a literature search at that time did not uncover similar cases. Apparently this is no longer the outlier I thought it was. This reinforces my resolve when I recommend capsulectomy to my patients when they seek disease prevention or treatments”.

Dr. Randall Feingold’s safety recommendations:

  • Ask  for enbloc explant surgery only. This is the only way your capsules can be entirely removed, screened and evaluated for abnormalities. 
  • Use only a plastic surgeon that is a member of the American Society of Plastic Surgeons – They are qualified and up to date. 
  • Do not depend only on Mammogram screening – you should ask for ultrasound too, especially if you have symptoms (pain, swelling, skin discoloration or change of shape). MRI may even be necessary to determine of there is a disease process. 
  • After explanting keep monitoring your breast for the same signs. Although rare, Cancer can appear years after you explanted. 
  • Be aware that cases of various lymphomas (not just ALCL) in the capsule around the breast implant have been reported.
  • Monitor your breast implants (if you still have them) for as long as you have them. If you notice any abnormal changes in your breasts or implants, promptly talk to your surgeon or health care provider..
  • Be aware that the FDA is now asking Medical Providers to characterize all findings and potential diagnoses when examining Breast Implants specimens, (for example, seroma, capsule, devices). Your doctor should submit specimens of your capsules to examine pathology and to rule out cancer. You should be notified within 10-14 days. 

How to report to the FDA

If you have breast implants and experience a problem, the FDA encourages you to file a report through Med Watch, the FDA Safety Information and Adverse Event Reporting program. Your report, along with information from other sources, can provide information that helps improve patient safety File your report here 

You can now have direct access to Dr. Randall Feingold’s Facebook group Here








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