FDA Recalls Textured Breast Implants over Cancer Concerns

FDA recalls, breast implants, medical device

In July, 2019, the U.S. Food and Drug Administration (FDA) requested that Pharmaceutical manufacturer, Allergan, recall certain textured breast implants.  FDA recalls like this one highlight ongoing concerns about breast implants and resulting illnesses.  It also continues the discussion about whether a warning or a medical device recall is more suitable to protect consumers.

In response to the FDA request, Allergan is recalling textured breast implant products due to the device being linked to breast implant-associated anaplastic large cell lymphoma (BIA-ALCL).

Important Information about the Recall

FDA recalls mean the associated product will no longer be available for purchase and usually that the manufacturer will collect the recalled product to destroy it.  In this case, the product is not available for sale directly to consumers, but rather must be removed from hospitals, doctors’ offices, and pharmacies.

Doctors in the United States and all over the world will no longer implant BIOCELL textured breast implants and tissue expanders.  Allergan does have two other breast implant products that are not included in this recall and may continue to be used by doctors and surgeons.  These products are:

  • NATRELLE smooth, and
  • MICROCELL breast implants and tissue expanders

How Do Breast Implants Cause Cancer? 

The type of cancer associated with textured breast implants is BIA-ALCL, which is a lymphoma, or cancer of the immune system cells.  BIA-ALCL is specifically not breast cancer.

Doctors don’t understand the connection between breast implants and BIA-ALCL.  Some researchers think the body can have an inflammatory reaction to the textured breast implant, which would cause immune cells to congregate on the site and possibly become cancerous.  Others suggest the immune system creates a bacterial “biofilm” to coat the surface of the implant.

No matter how it happens, the FDA is concerned that it is happening at all.  So far, 573 women around the world have received a diagnosis of BIA-ALCL.  The chance of contracting this type of lymphoma from an implant is about one in 30,000.  Still, the federal agency finds that statistic to be too high to ignore.  That is the reasoning for the FDA’s request that Allergan initiate the recall.

Are Textured Implants more Dangerous than Others?

According to the FDA, Allergan’s BIOCELL textured implants have the highest risk of causing BIA-ALCL.  Data published by the agency indicates a woman with BIOCELL implants is six times more likely to develop this cancer than the rate of any other implant.  This includes textured implants from other manufacturers like Mentor and Sientra.

The risk of breast implant illness applies to everyone with breast implants, but textured devices are the focus of FDA recalls at the moment because these implants have a rough outer shell which is distinct from both smooth breast implants and also from other textured devices.

What to Do When the FDA Recalls Your Implants

The FDA’s recommendation is to do “ watchful waiting.”  The agency says that the risks to preemptively remove an implant outweigh any benefit.   The reasoning behind the FDA’s request for this recall is to help future breast implant patients to avoid breast implant related cancer.

If you already have breast implants, it is very important to stay alert to signs and symptoms of adverse events.   Signs that are cause for concern if you have breast implants include:

  • Pain
  • Redness or swelling
  • Asymmetry
  • A new lump

If you have any of these symptoms, or are otherwise concerned about your health as it pertains to your breast implants, don’t hesitate to talk with your doctor.  A physical exam and imaging tests should help make a diagnosis.

How Will You Know if Your Implants are Subject to FDA Recalls?

Any patient who undergoes device or foreign body implantation surgery should receive a card from the medical device manufacturer.  This card should include information about the product or device including the brand name and a description.  If you have breast implants but don’t have this information, ask your plastic surgeon to identify the brand of your implants.

Because they are medical devices, every breast implant has an inventory number.  Hospitals and surgical centers keep this information on file in case of a situation like this.  Hospitals and clinics take preparatory measures in case a manufacturer issues in medical device recall.

What to Do if You are Planning to get Breast Implants?

If you are planning to get breast implants soon, the best thing to do is talk with your doctor or surgeon. Ask them directly about the risks and benefits.  Find out about the different brand names and types of implant.  It is very important to keep in mind that getting breast implants is major surgery and carries with it all the benefits and risks of a surgical procedure.

Breast implant illness is a well-known and well-documented phenomenon.  Especially in light of this recent FDA recall, your surgeon should discuss with you the risks and benefits for all different types of breast implants.  Beware if your surgeon offers textured BIOCELL implants made by Allergan.

If you are planning to get any medical device in your body, it is important that you gather information. Before surgery, find out about foreign materials and possible side effects.

Shifting Policies from the FDA

In late June of this year, the FDA released a statement indicating that it would continue to allow textured breast implants to be sold in the United States, if and only if, the products would begin to display a black box warning.  The purpose of this black box warning is specifically to remind doctors and patients of the risks of breast implant associated illness.  The risks include the lymphoma associated with the current Allergan recall.

Have Questions about Breast Implants and FDA Recalls?

If you have questions or concerns about breast implants and FDA recalls, you are not alone.  Dozens of women have been speaking out about their personal experiences with breast implant illness. Furthermore, women are exploring the danger some women face, especially from textured breast implants.  More women are also coming forward to share their experience with BIA-ALCL.

If you are one of the women battling BIA-ALCL or any form of breast implant illness, contact Drug and Device Watch.  You may have legal options if a medical device has caused you injury or illness.  Find out more by speaking with one of our legal professionals.

Call Drug and Device Watch if you are facing medical bills, lost income, or pain and suffering as a result of a medical device.   Call us toll free at 1-888-458-6825, or reach out online.  Our legal consultations are always free.