Elevated risk U.S. Food and Drug Administration

Biocell® textured breast implants and tissue expanders recall: Due to uncommon incidence of breast implant-associated anaplastic large cell

Recall published 7+ years ago

Due to uncommon incidence of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL)

Biocell® Medical devices — recalled medical devices
Photo published by U.S. Food and Drug Administration with the recall notice.

The hazard: Device safety concern

This is a device enforcement record. Check whether the remedy is a correction, a software update or a removal before changing anything.

What the notice says: Due to uncommon incidence of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL)

Why it matters: The FDA recorded an enforcement action against this device. Most device recalls are corrections rather than removals, so the device often stays in use while the manufacturer issues a fix.

Recall details

Published
July 24, 2019
Risk level
Elevated risk
Issued by
U.S. Food and Drug Administration
Brand
Biocell®
Product type
Medical devices

Products covered by this recall

BIOCELL® textured breast implants and tissue expanders

What the company announced

-- Global Action Follows Notification of Updated Safety Information from the U.S. Food and Drug Administration (FDA) --

-- FDA Does Not Recommend Removal or Replacement of Textured Breast Implants in Asymptomatic Patients --

--Smooth and MICROCELL®Breast Implants and Tissue Expanders Not Impacted --

DUBLIN, July 24, 2019/PRNewswire/ --Allergan plc (NYSE: AGN) today announced a voluntary worldwide recall of BIOCELL®textured breast implants and tissue expanders. 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 (BIA-ALCL) provided by the U.S. Food and Drug Administration (FDA).

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 Allergan. Allergan will provide additional information to customers about how to return unused products.

Patient safety is a priority for Allergan. Patients are advised to speak with their plastic surgeon about the risks and benefits of their implant type should they have any concerns.

Importantly, the FDA and other health authorities have not recommended removal or replacement of textured breast implants or tissue expanders in asymptomatic patients.

This global recall does not affect 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 Saline breast implant styles 168, 363, 468: Natrelle and McGhan 410 Soft Touch breast implant styles LL, LM, LF, LX, ML, MM, MF, MX, FL, FM, FF, FX
  • Natrelle Saline breast implant styles 168, 363, 468: Natrelle 510 Dual-Gel styles LX, MX, FX
  • Natrelle Saline breast implant styles 168, 363, 468: Natrelle INSPIRA breast implants, styles TRL, TRLP, TRM, TRF, TRX, TSL, TSLP, TSM, TSF, TSX, TCL, TCLP, TCM, TCF, TCX
  • Natrelle Saline breast implant styles 168, 363, 468: Natrelle and McGhan Round Gel Implants, styles 110, 110 Soft Touch, 120, 120 Soft Touch
  • Natrelle Saline breast implant styles 168, 363, 468: Natrelle Komuro breast implants styles KML, KMM, KLL, and KLM
  • Natrelle Saline breast implant styles 168, 363, 468: Natrelle Ritz Princess breast implant styles RML, RMM, RFL, RFM
  • Natrelle Saline breast implant styles 168, 363, 468: Natrelle 150 Full Height and Short Height double lumen implants
  • Natrelle Saline breast implant styles 168, 363, 468: 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 Saline breast implant styles 168, 363, 468: 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 with questions regarding this announcement can contact Medical Information at 1-800-678-1605 option #2 or [email protected] . For all other countries, please use the contact details at the following link on Allergan's website: Allergan Global Medical Information Contacts .

Adverse reactions 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

Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

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.

For more information, visit Allergan's website at www.Allergan.com .

Forward-Looking Statement

Statements contained in this press release that refer to future events or other non-historical facts are forward-looking statements that reflect Allergan's current perspective on existing trends and information as of the date of this release. Actual results may differ materially from Allergan's current expectations depending upon a number of factors affecting Allergan's business. These factors include, among others, the difficulty of predicting the timing or outcome of FDA approvals or actions, if any; the impact of competitive products and pricing; market acceptance of and continued demand for Allergan's products; the impact of uncertainty around timing of generic entry related to key products, including RESTASIS®, on our financial results; risks associated with divestitures, acquisitions, mergers and joint ventures; risks related to impairments; uncertainty associated with financial projections, projected cost reductions, projected debt reduction, projected synergies, restructurings, increased costs, and adverse tax consequences; difficulties or delays in manufacturing; and other risks and uncertainties detailed in Allergan's periodic public filings with the Securities and Exchange Commission, including but not limited to Allergan's Annual Report on Form 10-K for the year ended December 31, 2018 and Allergan's Quarterly Report on Form 10-Q for the period ended March 31, 2019. Except as expressly required by law, Allergan disclaims any intent or obligation to update these forward-looking statements.

CONTACTS:

Allergan:

Investors:

Manisha Narasimhan, PhD

(862) 261-7162

Christine Chiou

(862) 261-7396

Media:

Fran DeSena

(862) 261 8820

Mark Marmur

+44 7725 758677

Lisa Brown

(862) 261-7320

View original content to download multimedia: http://www.prnewswire.com/news

Additional Information

Reproduced from the company announcement posted on fda.gov. Links and contact forms in the original are not repeated here; the official notice below has them.

Check your product

The notice names 12 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

Model or item number

On the rating label, the box or the instruction sheet.

  • 168
  • 363
  • 468
  • 110
  • 120
  • 133FV
  • 133MV
  • 133LV
  • 133MX
  • 133SX
  • 133SV
  • T-133FV

Codes are lifted verbatim from the FDA — Company recall announcements notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Device

Biocell® — This is a device enforcement record. Check whether the remedy is a correction, a software update or a removal before changing anything.

  1. Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
  2. Ask the supplier or clinic that provided it what the remedy is in your case.
  3. If you are a facility, quarantine affected stock and log the correction.
  4. Report device problems to the FDA through MedWatch.

Replacements, repairs and reimbursement

Device remedies run through the supply chain, so the route depends on who sold you the unit.

  • Contact the distributor or clinic named on your paperwork and quote the recall number on this page. They will tell you whether the remedy is a repair, a replacement or an instruction update.
  • If the device was billed to insurance or Medicare, the replacement is usually billed the same way; you should not face a second deductible for a recall.
  • Keep every piece of correspondence. If a recalled device caused harm, that paper trail is what a claim rests on.
  • Consumer-purchased devices such as monitors and test kits are normally replaced free, with return shipping paid.

Remedy named in the notice: -- FDA Does Not Recommend Removal or Replacement of Textured Breast Implants in Asymptomatic Patients --

Company contact: Allergan plc — Consumers: Medical Information, 1-800-678-1605 option #2, [email protected] — Media: Fran DeSena, Mark Marmur, Lisa Brown, (862) 261 8820, +44 7725 758677, (862) 261-7320

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Company recall announcements record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Biocell® medical devices recalled?

Due to uncommon incidence of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) Due to uncommon incidence of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL)

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: model number 168, 363, 468. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.

Can I get my money back?

The notice says: -- FDA Does Not Recommend Removal or Replacement of Textured Breast Implants in Asymptomatic Patients --

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