EFFECTIVE IMMEDIATELY:

“When women decide to get breast implants for reconstruction after mastectomy or for breast augmentation, they should not be putting their lives at risk for lymphoma.”

– Diana Zuckerman

ALLERGAN has Voluntarily Recalled BIOCELL® Textured Breast Implants and Tissue Expanders worldwide.

These products will no longer be distributed or sold in any market where they are currently available.

Furthermore, healthcare providers should no longer implant new BIOCELL® textured breast implants and tissue expanders and unused products should be returned to Allergan.

According to the US Food and Drug Administration (FDA) out of 573 unique cases of BIA-ALCL that it had identified globally, 481 were attributed to Allergan implants. Out of 33 patient deaths, 12 of the 13 for which regulators could identify the manufacturer had an Allergan implant at the time of their BIA-ALCL diagnosis.

In Australia the Therapeutic Goods Administration (TGA) on July 11, announced a proposed ban or suspension of 31 models of textured implants and tissue expanders. It gave manufacturers till yesterday: July 24th to respond and is now considering responses from manufacturers as it decides whether to enact all the restrictions.

The proposed ban according to the ABC would block access to 45 percent of the breast implants that are currently on the market and being implanted into women.

Recent figures reveal that five women in Australia and New Zealand have died of breast implant-associated (BIA) ALCL Cancer and the 107 Australian women have been diagnosed with BIA ALCL Cancer.

Since the TGA’s announcement, the Australian Society of Plastic Surgeons has requested a meeting with Health Minister Greg Hunt to oppose the ban.

In our opinion both the FDA and TGA should have prioritised patients and not manufacturers in issuing this recall instead of allowing Allergan to voluntarily recall its implants.

In allowing Allergan to voluntarily decide to withdraw these implants from the market it legally protects them from future lawsuits.

Most recalls of medical devices including surgical mesh implants are described by the companies as voluntary.

You can access Allergan’s voluntary recall statement in the link below
https://www.allergan.com/news/news/thomson-reuters/allergan-voluntarily-recalls-biocell-textured-brea

If you require further information on breast implants you can access a closed support group in the link below 

https://www.facebook.com/groups/BreastImplantIllnessAustraliaNZ/?ref=share