BIOCELL® Product Safety Alert

BIOCELL® Product Safety Alert

Important Product Safety Alert of BIOCELL® Textured Breast Implants and Tissue Expanders

On July 24, 2019, Allergan announced a voluntary worldwide withdrawal of unused stock of BIOCELL® textured breast implants and tissue expanders from doctors’ offices and hospitals, and a suspension of any future sales which is part of the voluntary recall of BIOCELL® textured breast implants and tissue expanders. Natrelle smooth breast implants and MICROCELL® breast implants are not subject to this withdrawal. 

 

Why did we do this?

We took this action following notification by the U.S. Food and Drug Administration (FDA) of their recently updated global safety information. This information showed an association between breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) and Allergan BIOCELL® textured breast implants. Read the full news release

At this time, the likelihood of developing BIA-ALCL is thought to be low, occurring in less than 0.03% of patients with BIOCELL® textured breast implants. However, BIA-ALCL is a serious condition and can lead to death, especially if not diagnosed early or treated promptly. 

Learn more by selecting the Information about BIA-ALCL tab.  

 

What are BIOCELL® textured implants and tissue expanders?

BIOCELL® is the trade name of Allergan’s texturing process. Texturing on breast implants creates a rough surface as opposed to a smooth surface. Textured breast implants may be selected for a variety of reasons including to reduce the risk of capsular contracture, to help minimize implant movement and several others.

 

What is a “voluntary recall”?

This means that Allergan, the manufacturer, has willingly agreed to no longer make or sell these types of implants, and will retrieve the product from healthcare professionals. This product withdrawal from the market does not mean your implants need to be removed unless you have specific symptoms. Only unused products that are currently at doctor’s offices, hospitals, or surgery centers need to be returned. 

It is important to note that the US Food and Drug Administration (FDA) as well as international regulatory agencies do not recommend removal or replacement of textured breast implants or tissue expanders in patients without symptoms. 

BIA-ALCL symptoms include breast enlargement or hardening, persistent pain, lump in the breast or armpit, or a large fluid collection surrounding an implant. These symptoms have been reported between 6 months and 26 years after implant placement, and are typically diagnosed an average of 7 to 9 years after implant placement. BIA-ALCL is highly curable if detected early. Prompt diagnosis is key. Learn what is covered in your product warranty:

US Warranty Information

International Warranty Information

 

What Products are Affected?

Click here for the list of U.S. affected products

Contact your local Allergan Medical Information Contact for information on affected products in countries out side the U.S.
Please refer to the Allergan Global Medical Information Contacts list.

These products may have been sold under the brands McGHAN, INAMED, or Allergan Natrelle®. 

This global withdrawal does not affect Allergan’s Natrelle® smooth or Microcell® breast implants and tissue expanders. Natrelle® smooth breast implants and tissue expanders continue to be available to plastic surgeons and for patients. 

 

Who Do I Contact if I have Questions?

If you have questions about this voluntary product recall in the US please contact Medical Information:

US Phone: 1-800-678-1605, Option #2
US Email:  IR-Medcom@allergan.com

For all other countries, please refer to the Allergan Global Medical Information Contacts.

This site will be updated as new information becomes available.

 

BIOCELL® Product Safety Alert

What is BIA-ALCL?

BIA-ALCL is not breast cancer—it is a type of non-Hodgkin’s lymphoma (cancer of the immune system). In most cases, BIA-ALCL is found in the scar tissue and fluid near the implant, but in some cases, it can spread throughout the body. 

 

What is the likelihood of developing BIA-ALCL?

At this time, the likelihood of developing BIA-ALCL is thought to be low, occurring in less than 0.03% of patients with BIOCELL® textured breast implants. However, BIA-ALCL is a serious condition and can lead to death, especially if not diagnosed early or treated promptly. 

 

What are the symptoms of BIA-ALCL?

BIA-ALCL symptoms include breast enlargement or hardening, persistent pain, lump in the breast or armpit, or a large fluid collection surrounding an implant. These symptoms have been reported between 6 months and 26 years after implant placement, and are typically diagnosed an average of 7 to 9 years after implant placement. 

BIA-ALCL is highly curable if detected early. Prompt diagnosis is key. Learn what is covered in your product warranty:

US Warranty Information

International Warranty Information

 

How is BIA-ALCL treated?

In most patients, BIA-ALCL is treated successfully with surgery to remove the implant and the scar tissue surrounding the implant. However, a BIA-ALCL diagnosis is serious. Some patients may require additional treatment with chemotherapy and/or radiation therapy. 

 

What do I need to do if I have BIOCELL® textured breast implants or tissue expanders?

Patients with Allergan BIOCELL® breast implants or tissue expanders should be aware of the following important recommendations from the FDA:

  • If you have no symptoms, the FDA does not recommend the removal of these or other types of breast implants due to the low risk of developing BIA-ALCL. However, if you have any questions, talk to a board-certified plastic surgeon.
  • Know the symptoms of BIA-ALCL and monitor the area around your breast implants for any changes.
  • If you have symptoms, notice anything of concern about your breasts or suspect anything may be wrong with your implants or expanders, please speak with a board-certified plastic surgeon. Evaluation for BIA-ALCL typically involves a physical exam and assessment of the fluid and/or tissue around the breast implant. It is important to undergo an evaluation to diagnose BIA-ALCL since a confirmed BIA-ALCL diagnosis may change the type of operation that should be performed.
  • Based on discussions with your healthcare provider, patients with confirmed BIA-ALCL should undergo implant removal and removal of the surrounding scar capsule, which is a more extensive operation than implant removal alone.

As with any implanted device, it is good to keep a record of the device manufacturer, unique device identifier, and implant model name. You may have received this information on a patient device card from your surgeon. If you would like to obtain any of this information, consider asking your surgeon or obtaining the record of your surgery (operative notes) from the facility where it was performed.

Understand that most cases of BIA-ALCL occur many years after breast implant placement. Talk to a board-certified plastic surgeon about your risk of developing BIA-ALCL.
 
To read the FDA’s complete Q&A on BIA-ALCL please visit fda.gov.

 

BIOCELL® Resources for Patients & Consumers in the US

At Allergan, our first priority is to our patients. We are committed to ensuring the safe and effective use of our products. 

 

For more information please contact Allergan Medical Information: 

US Phone: 1 (800) 678-1605, Option #2
US Email:  IR-Medcom@allergan.com

For all other countries, please refer to the BIOCELL® Resources for International Patients & Consumers tab. 

 

Information on Style Numbers and Affected Products

If you know your style number, you can look it up on the affected product list:

Affected Products List 

If you do not know your style number, but have your patient card:

How Do I Find the Style Number on my Patient Card?

If you do not have any information about your implants available, please call Allergan Medical Information:

US Phone: 1 (800) 678-1605, Option #2

Please be prepared to share personal information required for implant identification. Due to patient privacy, we cannot provide information by email.

If you experiencing symptoms of BIA-ALCL, please reach out to a board-certified plastic surgeon. Patients are advised to speak with a board-certified plastic surgeon about the risks and benefits of their implant type should they have any concerns.

 

Warranty Information

I am considering replacing my devices. What are my options?

The FDA recommends not to remove implants in asymptomatic patients. However, for patients who decide to have their BIOCELL® textured implants removed, we will provide Allergan smooth replacement implants at no cost under the BIOCELL® Replacement Warranty.

 

What type of coverage do I have?

As part of the Natrelle® ConfidencePlus® Warranty you have comprehensive coverage including rupture, capsular contracture, late seroma, diagnosis of BIA-ALCL and more.

Natrelle® ConfidencePlus® Warranty

 

Additional Resources

Natrelle labeling information for all US Patients

Additional Resources for Reconstruction Patients

Additional Resources for Augmentation Patients

BIA-ALCL Resources by the American Society of Plastic Surgeons

 

Paper copies, including translations, of some resources can be provided upon request by calling Allergan Medical Information at 1 (800) 678-1605, option #2 or email IR-Medcom@allergan.com. To read a translated version of this statement, chose an option:

Arabic 

Chinese

French 

German 

Korean

Russian

Spanish

Tagalog

Vietnamese

BIOCELL® Resources for Healthcare Providers in the US

Effective immediately, healthcare providers should no longer implant new BIOCELL® textured breast implants and tissue expanders and unused products should be returned to Allergan. These products may have been sold under the brands McGHAN, INAMED, or Allergan Natrelle®.

 

For more information please contact Allergan Medical Information: 

US Phone: 1 (800) 678-1605, Option #2
US Email:  IR-Medcom@allergan.com

For all other countries, please refer to the Allergan Global Medical Information Contacts.

 

 

Resources

Affected Products List

Natrelle labeling information for all US Healthcare Providers

The American Society of Plastic Surgeons (ASPS) & the American Society for Aesthetic Plastic Surgery (ASAPS) informational Q&A for surgeons on BIA-ALCL

The National Comprehensive Cancer Network (NCCN) Consensus Guidelines on the Diagnosis and Treatment of Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL)

ASAPS Aesthetic Surgery Journal manuscript on the Management of Asymptomatic Patients With Textured Surface Breast Implants

BIA-ALCL FAQ for Physicians by the American Society of Plastic Surgeons

 

Warranty Information

 

BIOCELL® Replacement Warranty

The FDA recommends not to remove implants in asymptomatic patients. However, for patients who decide to have their BIOCELL® textured implants removed, we will provide Allergan smooth replacement implants at no cost under the BIOCELL® Replacement Warranty.

BIOCELL® Replacement Warranty

To Initiate a BIOCELL® Replacement Warranty Claim, submit a claim form here. For questions or to fill out the form on the phone, call Product Surveillance 1 (800) 624-4261 or email AUS-PSReporting@allergan.com.

 

Natrelle® ConfidencePlus® Warranty

The Natrelle® ConfidencePlus® Warranty offers comprehensive coverage including rupture, capsular contracture, late seroma, diagnosis of BIA-ALCL and more. 

Natrelle® ConfidencePlus® Warranty

 

How Do I Identify Patients with Textured Devices?

You can identify patients with textured devices using NEXTECH. An instructional video is available here.

You can also request patient information from Allergan Product Support. This dataset may be helpful but would be limited to the data submitted for each patient in the device tracking form. Email DL-AUS-DeviceTracking@Allergan.com to initiate the process.

You must include the following information:

  • Name of physician
  • Phone number
  • Address(es)
  • Company email address (This is needed to access the secured electronic box account)

Please note, it may take 2-3 weeks to complete your request.

Patients who do not have any information about their implants available can call Allergan Medical Information:

US Phone: 1 (800) 678-1605, Option #2

Personal information is required for implant identification. Due to patient privacy, we cannot provide information by email.

 

How Do I Return Product?

US Healthcare Providers must return unused products to Allergan. Below are the actions required:

  1. If you have inventory of the recalled products, quarantine product to prevent its use.
  2. Conduct a physical count of the affected products in your possession and record the count on the Recall Stock Response Form.
  3. Send the Recall Stock Response Form to Inmar Rx Solutions, Inc via fax or email within five (5) business days of receipt. To ensure we are able to account for all recalled product, please return the Response form even if no recalled product is present.
  4. Upon receipt of the Response Form, Inmar will issue Return Authorization label(s).
  5. When returning the recalled products, attach the prepaid FedEx Authorized Return shipping label to the outside of the return carton and return the recalled product to:
    Inmar Rx Solutions, Inc.
    4332 Empire Rd. Fort Worth, TX 76155

 
Please contact Inmar Rx Solutions, Inc. if you have any questions about these recall actions in the United States.
Please do not return any products that are not the subject of this recall. 

 

At Allergan, our first priority is to our customers and patients. We are committed to ensuring the safe and effective use of our products.

 

Paper copies, including translations, of some resources can be provided upon request by calling Allergan Medical Information at 1 (800) 678-1605, option #2 or email IR-Medcom@allergan.com. To read a translated version of this statement, chose an option:

Arabic

Chinese

French

German 

Korean

Russian

Spanish

Tagalog

Vietnamese

BIOCELL® Resources for International Patients & Consumers

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

 

For local information on this withdrawal and affected products, please contact Allergan Medical Information through the appropriate phone number found in the Allergan Global Medical Information Contacts list.

You may access a local website through the appropriate link found in the Allergan global websites list.

BIOCELL® Resources for International Healthcare Providers

Effective immediately, healthcare providers should no longer implant new BIOCELL® textured breast implants and tissue expanders and unused products should be returned to Allergan. These products may have been sold under the brands, McGhan, Inamed, Allergan, or Natrelle.

For local information on this withdrawal and affected products, please contact Allergan Medical Information through the appropriate phone number found in the

Allergan Global Medical Information Contacts list.


Note: On December 19, 2018, Allergan suspended sales and withdrew supply of textured breast implants in the European market following expiration of its CE mark certificates. On May 28, 2019, Allergan voluntarily recalled BIOCELL® textured breast implants from the Canadian market.

You may access a local website through the appropriate link found in the Allergan global websites list.