Allergan Breast Implant Recall

breast implant recall

BREAKING NEWS – Keep Calm and Carry On if You Have Breast Implants! Here are the Facts About Breast Implants and the Recent Recall of Textured Allergan Breast Implants.

On July 24, 2019, Allergan recalled its textured breast implants and tissue expanders in the US. This was done at the request of the FDA due to reports of newly-identified cases of BIA-ALCL (breast implant-associated anaplastic large cell lymphoma).

What is BIA-ALCL?

BIA-ALCL is a cancer involving white blood cells. These are the cells in the blood that are tasked with fighting infection.

BIA-ALCL is NOT breast cancer, as we normally refer to it.

In an abundance of caution, the FDA requested that Allergan remove TEXTURED implants and tissue expanders, used mostly in breast cancer reconstruction, from use in the US.

Lymphomas, which are a large and diverse group of blood cancers, frequently are found where white blood cells come together as a group—mostly within lymph nodes. For reasons that are not entirely known, the outside covering of breast implants can develop an aggregation of white blood cells and RARELY some of the white blood cells can turn into a lymphoma.

There have been 573 cases reported in the last 20 years worldwide. It is estimated that there have been close to 10 million implants used in this time period, so this is indeed RARE. The vast majority, though, have been associated with TEXTURED implants manufactured by Allergan, previously also known as McGhan.

This recall does NOT involve Mentor implants, the other major manufacturer.

How do I know if I should be concerned?

First, remember that these are RARE cases.

If you have had breast augmentation or breast reconstruction, determine the type of implant you have—textured or smooth-shelled. (Texturing refers to the outside covering of the implant. Implants are either smooth or textured. The filling is either saline or silicone gel.

There is NO EVIDENCE that BIA-ALCL is more associated with silicone gel vs. saline.)

Refer back to the implant identification card you received from your surgeon after your procedure. This should indicate the type you had implanted. Sometimes, the ID cards display only a product or serial number. In that case, call your plastic surgeon for more definitive information.

What should I do if I have textured implants that have been recalled?

If you have further questions about your breast implants, you may contact Valley Plastic Surgery & Medi-Spa at any time.

There is no recommendation from either the FDA or any plastic surgery organization that asymptomatic women (see below) with textured implants should have them removed or replaced. However, your plastic surgeon will have the most up-to-date information. You should certainly make contact with a plastic surgeon regarding your particular situation if you do have textured implants.

How would I know if I have BIA-ALCL?

The most common symptom would be an evolving enlargement of either (but NOT both) breasts months to years after having breast implant surgery. This would possibly indicate a fluid collection around the implant. A fluid collection that develops several months to years after breast augmentation or reconstruction, called a late seroma, should be immediately brought to the attention of your plastic surgeon.

Rest assured that even when a fluid collection develops in this manner, it is still RARE that this is BIA-ALCL.

Some women with BIA-ALCL have developed breast lumps or masses, rather than a late seroma as the first sign. Again, any change or abnormality in the breast should be assessed by your primary care physician, Ob-Gyn, or your plastic surgeon. Of note, a mammogram is not a test to diagnose BIA-ALCL. There are currently no blood tests that can screen for BIA-ALCL.

Can I CHOOSE to have further surgery to replace my textured implants with smooth implants?

Allergan ImplantsThe good news is that there are options! No one wants for women with textured implants to be anxious and worried. Many women with breast implants choose to have further breast surgery in order to change the size, or to have a lift after a certain number of years. This may be another reason to consider moving forward with a procedure. In most circumstances, textured implants can be removed and replaced with smooth implants that are very similar.

However, there may be very individualized and particular circumstances that led to you and your surgeon selecting textured implants in the first place. The best course of action is to call your plastic surgeon for expert consultation and guidance.

Further Questions about the Breast Implant Recall?

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