Allergan recalls Biocell implants
Allergan has said it will be recalling its Biocell textured breast implants and tissue expanders following a report by the US Food and Drug Administration (FDA).
The textured implants have been linked to BIA-ALCL (breast-implant associated anaplastic large cell lymphoma), a cancer of the immune system.
The recall does not affect Allergan's Natrelle Smooth (also silicone) or Microcell breast implants and tissue expanders.
Effective immediately, healthcare providers should no longer implant Biocell implants and unused products should be returned to Allergan.
Following the news and the airing of a Channel 4, Dispatches, that questioned the safety of breast implants, the British Association of Aesthetic Plastic Surgeons (BAAPS) released a statement advising concerned patients need not take any action at this stage. They said that patients should continue their routine follow up with their healthcare professional and discuss any questions they have about their breast implants with their practitioner.
Consultant plastic and hand surgeon and vice president of BAAPS Miss Mary O’Brien, said, “Breast implant illness is a lay term describing a wide range of symptoms experienced by group of patients that they attribute to their breast implant surgery. Currently, this is not a recognised medical diagnosis and therefore there are no diagnostic criteria nor investigative protocols. The reality is that a small proportion of patients exist who are very troubled by these nonspecific symptoms. This group of patients deserve respect from clinicians in being listened to and supported going forwards. This support is not necessarily surgical. Further robust research is one way forward to find answers along with collaboration with the MHRA, breast implant registry and other professional associations and patient groups.”
Allergan posted a release on its website on July 24 which is summarised below:
BIOCELL® saline-filled and silicone-filled textured breast implants and tissue expanders will no longer be distributed or sold in any market where they are currently available. Effective immediately, healthcare providers should no longer implant new BIOCELL® textured breast implants and tissue expanders and unused products should be returned to
Patient safety is a priority for
Importantly, the
This global recall does not affect
The recalled products include:
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Natrelle Saline breast implant styles 168, 363, 468 |
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Natrelle and McGhan 410 breast implant styles LL, LM, LF, LX, ML, MM, MF, MX, FL, FM, FF, FX |
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Natrelle and McGhan 410 Soft Touch breast implant styles LL, LM, LF, LX, ML, MM, MF, MX, FL, FM, FF, FX |
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Natrelle 510 Dual-Gel styles LX, MX, FX |
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Natrelle INSPIRA breast implants, styles TRL, TRLP, TRM, TRF, TRX, TSL, TSLP, TSM, TSF, TSX, TCL, TCLP, TCM, TCF, TCX |
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Natrelle and McGhan Round Gel Implants, styles 110, 110 Soft Touch, 120, 120 Soft Touch |
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Natrelle Komuro breast implants styles KML, KMM, KLL, and KLM |
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Natrelle Ritz Princess breast implant styles RML, RMM, RFL, RFM |
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Natrelle 150 Full Height and Short Height double lumen implants |
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Natrelle 133 tissue expanders with and without suture tabs: styles 133FV, 133MV, 133LV, 133MX, 133SX, 133SV, T-133FV, |
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Natrelle 133 Plus tissue expander styles 133P-FV, 133P-MV, 133P-LV, 133P-MX, 133P-SX, |
Adverse events or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting Program either online, by regular mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- Regular Mail or Fax: download form www.fda.gov/MedWatch/getforms.htm or call 1-800-
FDA -1088 to request form, then complete and return address on the pre-addressed form, or submit by fax to 1-800-FDA -0178.
