Textured Implant Recall

The textured breast implant recall

Allergan's BIOCELL textured implants were recalled in 2019. Smooth implants were not.

The approach

What was recalled

On July 24, 2019, at the FDA's request, Allergan recalled unused BIOCELL textured breast implants and certain tissue expanders because of a higher risk of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). The recalled products include Natrelle saline-filled implants, Natrelle silicone-filled implants, Natrelle Inspira silicone-filled implants, Natrelle 410 highly cohesive anatomically shaped implants, and the Natrelle 133 Plus and Natrelle 133 tissue expanders with suture tabs.

Smooth-surface implants were not part of that recall. The recall removed unused stock from hospitals and offices. The FDA did not recommend removing a textured implant from a woman who has no symptoms, because the lymphoma is uncommon and surgery has its own risks.

What the FDA did ask is that women know the surface of their implant and watch for delayed swelling, a lump, pain, or a change in shape, often years after surgery. Those symptoms need an exam, not a wait-and-see message from a website. The illness itself is described on the BIA-ALCL page.

If your card says BIOCELL or you do not know the surface, bring the operative note. We can request it.

This is general information about how these questions are usually approached. It is not a diagnosis, and it does not replace a visit. Screening and treatment are planned for one person at a time.

If you already have a recalled implant

The 2019 recall took Allergan BIOCELL textured implants and certain tissue expanders off the shelf. It did not order surgery for every woman who already has one. The FDA's position is that asymptomatic women do not need automatic removal, because BIA-ALCL is uncommon and an operation has risk. That is a population statement. Your decision can still be to take them out, and that choice is a consultation, not a violation of the guidance.

What you do need is the model name. BIOCELL is a specific textured surface. Other textured implants, and all smooth implants, were not in that Allergan recall. The card, the sticker in the operative packet, or the hospital record will say. If you cannot find it, the office that placed the implant can usually produce it, and we can request it before you travel.

While a recalled implant stays in, know the symptoms that should not wait: one-sided swelling, a mass, pain, or a late change in shape. Those are examined for contracture, rupture, and BIA-ALCL. None of the three is diagnosed from the model number alone.

Common questions

Frequently asked questions

Should I have a recalled implant removed if I feel well?

The FDA did not recommend routine removal for women without symptoms. A personal choice to remove them is still reasonable to discuss. It is not an emergency by itself.

How do I know if mine were textured?

The implant card, the operative report, or the device record names the model. If you do not have those, the office that placed them usually does.

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