Recall Informer

Breast Implants Recalled for Cancer Risk

  • The FDA has recently determined that textured breast implants manufactured by Allergan Biocell should be removed from the U.S. market completely.
  • Patients who have received implants from Allergan Biocell are at a greater risk of breast cancer.
  • Of the 573 cases of BIA-ALCL, 84% of them are linked to Allergan Biocell’s implants.
  • Although 35 countries have banned the use of textured implants, the United States is not one of them since they only make up 5% of the procedures.
  • The FDA has known since 2011 that textured implants were linked to breast cancer.

Textured breast implants made by manufacturer Allergan Biocell is linked to a number of deaths from a rare form of cancer. The FDA recently recommended that they no longer be sold in the United States, joining a worldwide movement to ban these implants.

Greatly Increased Risk of Rare Cancer

Patients who received these implants have an increased risk of developing breast-implant anaplastic large cell lymphoma, or BIA-ALCL. Although this is not technically breast cancer, the lymphoma spreads from tissue near the implants.

The textured implants produced by Allergan have six times the risk of developing this type of lymphoma than any other similar implants.

The total number of BIA-ALCL cases worldwide is 573, making it a very rare form of cancer. However, a staggering 84% of those cases (481) are linked specifically to Allergan’s Biocell implants. To date, 33 women have died from BIA-ALCL.

A Worldwide Ban

In April of this year, textured breast implants—including those made by Allergan—were banned in Canada and France. Australia banned them earlier this month, bringing the worldwide total up to 35 countries who do not allow textured implants.

The United States is not one of the countries that have banned textured implants. However, the U.S. Food and Drug Administration just reversed its decision to allow Allergan’s implants to stay on the market in this country. Textured implants are more common in Europe, but in the United States they make up just 5% of total procedures.

FDA commissioner Amy Abernethy did not fully explain the reason why they waited to take action, despite mounting evidence. In a press release, Abernethy wrote, “Although the overall incidence of BIA-ALCL appears to be relatively low, once the evidence indicated that a specific manufacturer’s product appeared to be directly linked to significant patient harm, including death, the FDA took action.”

The FDA has known since 2011 that this particular type of implant is linked to increased cancer risk. They are not currently advising that patients with textured implants made by Allergan be removed at this time unless they experience any symptoms or health problems that might be related to the implants.

Which Implants Have Been Recalled?

The specific implants recalled are:

  • Natrelle Saline breast implant styles 168, 363, 468
  • Natrelle and McGhan 410 breast implant styles LL, LM, LF, LX, ML, MM, MF, MX, FL, FM, FF, FX
  • Natrelle and McGhan 410 Soft Touch breast implant styles LL, LM, LF, LX, ML, MM, MF, MX, FL, FM, FF, FX
  • Natrelle 510 Dual-Gel styles LX, MX, FX
  • Natrelle INSPIRA breast implants, styles TRL, TRLP, TRM, TRF, TRX, TSL, TSLP, TSM, TSF, TSX, TCL, TCLP, TCM, TCF, TCX
  • Natrelle and McGhan Round Gel Implants, styles 110, 110 Soft Touch, 120, 120 Soft Touch
  • Natrelle Komuro breast implants styles KML, KMM, KLL, and KLM
  • Natrelle Ritz Princess breast implant styles RML, RMM, RFL, RFM
  • Natrelle 150 Full Height and Short Height double lumen implants
  • Natrelle 133 tissue expanders with and without suture tabs: styles 133FV, 133MV, 133LV, 133MX, 133SX, 133SV, T-133FV, T-133MV, T-133LV, T-133MX, T-133SX, T-133SV, 133FV-T, 133MV-T, 133LV-T, 133MX-T, 133SX-T, 133SV-T
  • Natrelle 133 Plus tissue expander styles 133P-FV, 133P-MV, 133P-LV, 133P-MX, 133P-SX, 133P-SV, T-133P-FV, T-133P-MV, T-133P-LV, T-133P-MX, T-133P-SX, T-133P-SV, 133P-FV-T, 133P-MV-T, 133P-LV-T, 133P-MX-T, 133P-SX-T, 133P-SV-T