Breast Implant Illness and Safety

Breast Implant Illness & Safety

Breast implants have been the subject of controversy over the years and are among the most studied medical devices in the world. After extensive research, the FDA determined that breast implant illness was not the result of exposure to silicone, and that silicone shell and silicone-filled implants were safe for use in breast augmentation.

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FDA recall of Allergan textured implants

On July 24, 2019, Allergan recalled its line of Biocell textured implants, which includes the following types:

• Natrelle Saline-Filled breast implants
• Natrelle Silicone-Filled breast implants
• Natrelle Inspira Silicone-Filled breast implants
• Natrelle 410 Highly Cohesive Anatomically Shaped Silicone-Filled breast implants
• Textured shell tissue expanders have also been recalled

The recall was requested by the FDA due to reports that over 700 patients had developed a rare cancer, BIA-ALCL, or “breast implant associated large cell anaplastic lymphoma,” the majority of whom had breast augmentation with Allergan textured implants. BIA-ALCL is very treatable and can be cured when identified early. This cancer does not affect the breast tissue but develops in and around the scar tissue capsule around the implant. It affects the immune system.

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What are the symptoms of BIA-ALCL?

The symptoms that may indicate the cancer include:

• Unexplained swelling of the breast, years after implantation
• Breasts appear uneven in size
• Liquid is forming around the implant
• Rash appears on the breast
• Lumps in breast or armpit
• Pain
• Hardened breast
• Reddened breasts

All these symptoms could easily indicate another problem, rather than BIA-ALCL. Please see your surgeon if you have any questions.

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What to do if you have Natrelle textured implants

If you have no symptoms and your breasts are fine, you simply need to continue with regular checkups and report any changes to Dr. Sadrian. If you have symptoms, get tested. The test involves an ultrasound, followed by extracting liquid from the breast and getting it tested. Keeping a close eye on your implants is the best way to ensure you stay healthy, no matter what type of implants you have.

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Should I have my textured implants removed?

Many women with textured implants are frightened by this recall. It is important to understand that although the implants have been recalled, only a very low percentage of people have developed this cancer, and the reasons are not yet understood. Until further studies are complete, it is not clear why these implants are linked to an increased incidence of BIA-ALCL. It is best to keep a watchful eye on your breasts, and if you notice unusual changes, tell your doctor. If you want to have them removed and replaced with smooth shell implants, this can be discussed with Dr. Sadrian.

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What is different about textured implants?

Textured implants were developed to help women avoid capsular contracture, one of the more common complications of breast implants. The textured surface of the implant made it less likely to move out of place, particularly beneficial for “anatomical” implants, which have a teardrop shape. Textured implants have been very effective in achieving that purpose, but due to the FDA recall, it is important that you are aware that a small percentage of patients have developed BIA-ALCL.

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What is my risk?

Your risk of developing BIA-ALCL from textured implants is low. With the current data, which is limited, it appears that the risk is in the range of one in 3,817 and one in 30,000. It is clear that more research is needed, but until that time, it is advised that you stay aware of the condition of your breasts and call us should you notice any changes or symptoms – something you should always do, whether you have textured or smooth shell implants.

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What should I do now?

It is always important to have regular checkups from a board-certified plastic surgeon. Should you notice any change, schedule a test. Breast implants are manmade devices and will not last forever, requiring replacement at some point. Dr. Sadrian focuses on helping his patients stay healthy and happy and is available to meet with you to discuss your concerns. As BIA-ALCL appears after the implants have been in place for years, at an average of 8, but between 2 and 28, the illness takes some years to develop. What is important is that the condition is identified in its earliest stage, as BIA-ALCL is very curable at that point. We are here to help.

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