Allergan plc announced July 24th a voluntary worldwide recall of BIOCELL® textured breast implants and tissue expanders.
The initiative came in response to a request from the Food and Drug Administration (FDA), in order to protect patients from the increased risk of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). According to the FDA, this type of illness has been associated with Allergan BIOCELL textured breast implants, prompting the FDA to require Allergan to recall its BIOCELL textured breast implants and tissue expanders.
These products have a BIOCELL textured surface (shell), used only by Allergan.
The company agreed to recall these implants and is removing them from the global market.
The action is being taken as a precaution in response to recent information concerning the incidence of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) in patients using all types of implants.
Recommendation made based on a recent medical device report
The FDA request was based on newly submitted Medical Device Reports (MDRs) reporting worldwide cases of BIA-ALCL and BIA-ALCL-related deaths associated with BIOCELL textured breast implants and tissue expanders marketed in the U.S.
According to the FDA’s analysis, the report caused concern. 573 worldwide unique BIA-ALCL cases, including 33 patient deaths, were reported. Of the 573 cases of BIA-ALCL, 481 patients had Allergan breast implants when diagnosed. More importantly, 12 of 13 reported deaths of patients with BIA-ALCL whose implants were from a known manufacturer were indeed implanted with an Allergan breast implant when diagnosed with BIA-ALCL. For the other 20 reported deaths from BIA-ALCL, the manufacturer and/or texture was unknown.
Based on currently available information, including the newly submitted data, the FDA says their analysis demonstrates the risk of BIA-ALCL with Allergan BIOCELL textured implants is approximately 6 times the risk of BIA-ALCL with textured implants from other manufacturers marketing in the U.S.. Therefore, continued distribution of Allergan’s BIOCELL textured breast implants would likely cause serious, adverse health issues and potentially death from BIA-ALCL.
What is breast implant-associated anaplastic large cell lymphoma
It is important to underline BIA-ALCL is not breast cancer – it is a type of non-Hodgkin’s lymphoma (cancer of the immune system). Although it is not breast cancer, in most cases BIA-ALCL is found in the scar tissue and fluid near the implant. In some cases though, it can spread to other organs throughout the body. The overall incidence of developing BIA-ALCL is considered to be low at this time; but a BIA-ALCL diagnosis is serious and, especially if it is not found in the early stages and treated accordingly, it can lead to death. In most patients, BIA-ALCL is treated successfully with surgery to remove the implant and the scar tissue surrounding the implant. Some patients may however require chemotherapy and/or radiation therapy.
BIOCELL implants will be taken off the market
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. Healthcare providers should no longer implant new BIOCELL® textured breast implants and tissue expanders and unused products should be returned to Allergan. Allergan will provide additional information to customers about how to return unused products.
Patient safety is a priority for Allergan. Patients should discuss the risks and benefits of their implant type with their cosmetic surgeon should they have any concerns.
It is important to note that the FDA and other health authorities have not issued a recommendation for the removal or replacement of textured breast implants or tissue expanders in asymptomatic patients.
This global recall does not include Allergan’s NATRELLE® smooth or MICROCELL® breast implants and tissue expanders.
The recalled products include:
|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
U.S. healthcare providers can contact Medical Information at 1-800-678-1605 option #2 or IR-Medcom@allergan.com for any questions related to this announcement.
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.
The FDA could take action regarding other breast implants, if the continuous evaluation of new information would reveal harmful effects on patients. Although most cases of BIA-ALCL are associated with the use of textured breast implants, particularly macro-textured implants – such as those made by Allergan, the FDA is seeking to determine whether the risk of developing BIA-ALCL is limited to specific models of textured implants or could expand to other types. Therefore, at the present time, the FDA believes that all individuals who are considering a breast implant of any type should be informed of the risk of developing BIA-ALCL.
About Allergan plc
Allergan plc (NYSE: AGN), headquartered in Dublin, Ireland, is a global pharmaceutical leader focused on developing, manufacturing and commercializing branded pharmaceutical, device, biologic, surgical and regenerative medicine products for patients around the world. Allergan markets a portfolio of leading brands and best-in-class products primarily focused on four key therapeutic areas including medical aesthetics, eye care, central nervous system and gastroenterology. As part of its approach to delivering innovation for better patient care, Allergan has built one of the broadest pharmaceutical and device research and development pipelines in the industry.
With colleagues and commercial operations located in approximately 100 countries, Allergan is committed to working with physicians, healthcare providers and patients to deliver innovative and meaningful treatments that help people around the world live longer, healthier lives every day.