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FDA Recall of Textured Breast Implants

Posted August 08, 2019 in Breast Revision, News

The U.S. Food and Drug Administration (FDA) recently requested a recall on Allergan’s BIOCELL® textured breast implants due to an association between these implants and BIA-ALCL, or breast implant-associated anaplastic large cell lymphoma.

Both saline and silicone-filled textured breast implants (and tissue expanders) were included in the recall and are no longer being distributed or sold throughout the world. Other brands of textured implants, as well as smooth Allergan implants, are unaffected by this voluntary recall. Do you have textured implants and feel confused about what to do next? We’ve written some detailed information about the breast implant recall and what to keep an eye on.

Doctor holding textured breast implant

Should I Be Concerned?

Five hundred seventy-three cases of BIA-ALCL have been reported, and 33 deaths. The risk of developing this disease is low, as are death rates in those who are diagnosed, but patients should know what to look for if they are concerned about their textured Allergan BIOCELL® implants.

If you experience signs or symptoms of potential problems as mentioned below, then please contact your nearest doctor to seek treatment. Dr. Rosen is happy to schedule an appointment with you to discuss your concerns and see if breast revision surgery is recommended or necessary.

How to Diagnose and Treat Breast Implant-Associated Anaplastic Large Cell Lymphoma

Unless you are experiencing signs of breast implant problems, there is likely nothing to be worried about. Symptoms may include:

  • Breast cysts
  • Breast pain
  • Compromised immune system
  • Fibromyalgia
  • Lumps after breast augmentation
  • Rash
  • Scars
  • Sharp pain
  • Swollen chest (seroma)

Breast Cancer Treatments

Fully removing the implants and surrounding capsule (scar tissue) can eliminate BIA-ALCL when caught early. Textured Allergan breast implants associated with BIA-ALCL can be removed and replaced with new implants or with fat transfer to the breasts. Fat transfer, rather than replacing the implants with new ones, utilizes liposuction to harvest fat from specific areas of the body, usually the thighs, arms, abdominal area, or buttocks. Fat cells are purified for transfer to the breasts for subtle, natural cleavage enhancement.

Should I Have My Implants Removed?

The FDA is recommending that textured implants only require removal if you experience adverse side effects or notice an increase in your breast size. BIA-ALCL can produce a fluid accumulation in the breast implant area, which sometimes results in painful, enlarged breast tissue.

If you believe that you are experiencing symptoms of an infection or cancer, you can schedule an appointment with Dr. Rick Rosen to assess your breasts and discuss your symptoms to see if treatment is necessary.

Finger touching textured breast implant

You may learn more about the FDA’s recall of textured breast implants by visiting their site.

If you would like to discuss your breast implants and whether implant removal is right for you, please call 203.899.0000 to schedule a consultation with board-certified plastic surgeon Dr. Rick Rosen.

Norwalk Office

91 East Avenue
Norwalk, CT 06851

Phone: 203.899.0000