Allergan Implant Recall

Recently, certain textured breast implants have been linked to an extremely rare lymphoma called breast implant-associated anaplastic large cell lymphoma (BIA-ALCL).  While the incidence of BIA-ALCL is exceedingly rare, it has been found to be roughly six times higher in Allergan Biocell textured implants.  Accordingly, Allergan has recalled all Biocell implants worldwide.  Smooth implants have not been affected. Below we summarize some information regarding BIA-ALCL and some frequently asked questions.

 

What is the Allergan textured breast implant recall?  Which implants are affected?

On July 24, 2019, Allergan, one of three major breast implant manufacturers in the United States, voluntarily recalled all Biocell textured breast implants and tissue expanders worldwide.  This action was based on updated global safety information provided by the FDA on the incidence of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL).  No smooth implants (those implants whose shells are not textured) were recalled and no other implant companies’ textured implants were involved in this recall. 

 

What is breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) and how common is it?

BIA-ALCL is not breast cancer.  BIA-ALCL is a rare non-Hodgkin lymphoma that may occur in the scar tissue and/or fluid surrounding a breast implant.  The risk of developing BIA-ALCL is exceedingly low with reported incidences between 1:2,207 to 1:86,029 in studies of all textured implant manufacturers.  Currently there have been 573 confirmed cases of BIA-ALCL worldwide.  (For reference, the worldwide estimate of women with breast implants is over 30 million.)  There have been no confirmed cases of BIA-ALCL in patients with only a history of smooth shelled implants. Additionally, the majority of reported cases of BIA-ALCL to date have involved Allergan textured implants.

 

What are the symptoms of BIA-ALCL?

The most common symptom of BIA-ALCL is fluid accumulation around the breast which can cause swelling, pain, or lumps in the breast or armpit.  Typically, these symptoms present months to years after surgery with most occurring between 3 and 14 years after surgery.

 

How is BIA-ALCL treated?

BIA-ALCL is treated in most patients by removing the implant and scar tissue surrounding the implant.  Infrequently, patients may require chemotherapy and radiation.  In very rare cases it can spread throughout the body or lead to death.  Worldwide there have been 33 confirmed patient deaths related to BIA-ALCL.

 

What should I do if I have textured implants or if I don’t know what type of implants I have?

Currently, the FDA does not recommend removal of textured implants in women who are asymptomatic.  Women should be aware of the possible symptoms and if there are any concerns should visit a plastic surgeon for evaluation.  If the implant type is unknown, women should contact their surgeon for records or visit a plastic surgeon for evaluation.  

For women with known Allergan Biocell implants, Allergan is offering free replacement smooth implants until July 24, 2021.  Textured implants manufactured under the labels Allergan, McGhan, Inamed, or Natrelle may be included.  Bring your current patient ID card or any other information available about your implants with you to your appointment. You and your plastic surgeon will decide on the best size and style as a replacement option for you. Your plastic surgeon will request your replacement implants from Allergan on your behalf.  Surgery fees are not covered under this warranty program.  More information regarding this warranty program may be found at: https://allergan-web-cdn-prod.azureedge.net/actavis/actavis/media/allergan-pdf-documents/biocell-replacement-warranty.pdf

 

In line with our commitment to our patient’s safety, we are offering screenings and evaluations of any new or existing patients with concerns regarding their breast implants.  Please contact our office to schedule an appointment.

 

For more information please visit the FDA website at: 

https://www.fda.gov/medical-devices/breast-implants/questions-and-answers-about-breast-implant-associated-anaplastic-large-cell-lymphoma-bia-alcl

 

 

James M. Economides, MD

@dreconomides

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