As more women have become ill or have died from a rare cancer linked to certain breast implants, Allergan has announced a voluntary worldwide recall of its textured implants.
The Food and Drug Administration called for the move on Wednesday after it found a higher risk of breast implant associated-anaplastic large cell lymphoma (BIA-ALCL) linked to those devices. More than three dozen countries have already pulled that brand of implants.
“Allergan is taking this action as a precaution following notification of recently updated global safety information concerning the uncommon incidence of breast implant-associated anaplastic large cell lymphoma,” the company said in a statement.
On Wednesday, the FDA announced there are now 573 cases of BIA-ALCL worldwide and 33 people have died, a “significant increase” since the agency’s last update earlier this year — reflecting 116 new cases and 24 more deaths.
The risk of developing BIA-ALCL — a type of non-Hodgkin's lymphoma — with Allergan BIOCELL textured implants is about six times that of becoming ill with textured implants from other manufacturers available in the U.S., the FDA said.
Of the 573 cases of BIA-ALCL, 481 were attributed to Allergan implants, and 12 of the 13 patients for whom the implant manufacturer was known had an Allergan implant when they were diagnosed, it added.
“Based on new data, our team concluded that action is necessary at this time to protect the public health,” said Dr. Amy Abernethy, FDA principal deputy commissioner, in a statement.
Some doctors believe the textured surface leads to "an interaction between the woman's body and the implant."
The recall affects all of Allergan’s BIOCELL textured breast implants and tissue expanders, with the company instructing doctors to no longer use them, effective immediately. They include:
- 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
Any unused products will be removed from suppliers and doctors’ offices, the FDA noted. Textured breast implants account for only 10% of implants sold in the U.S.
If you have Allergan BIOCELL textured breast implants:
- The FDA does not recommend removing the implants if you have no symptoms. It calls the risk of developing BIA-ALCL "low."
- Symptoms to look for include swelling or pain near the breast implant. Monitor that area of your body for any changes and tell your doctor if you notice anything unusual. Most cases of BIA-ALCL develop many years after women get breast implants.
- A physical exam, imaging and testing of the fluid or tissue around the breast implant can determine a BIA-ALCL diagnosis.
- Patients with confirmed BIA-ALCL should have the implant and the surrounding scar capsule removed — a more extensive surgery than implant removal alone.