Posts tagged FDA recall
FDA and Allergan issue recall of BIOCELL® textured breasts implants: What every woman needs to know.
 
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This week, emerging data prompted the FDA to notify Allergan, a global pharmaceutical company, about the link between their BIOCELL® textured breast implants and a rare type of lymphoma. France, Australia, and Canada previously made similar announcements. Although Allergan is NOT the only implant manufacturer offering textured breast implants, the incidence of Breast Implant Associated - Anaplastic Large Cell Lymphoma (BIA-ALCL) was more frequently associated with Allergan’s BIOCELL® textured breast implants. This has led Allergan to voluntarily issue a world-wide recall of their BIOCELL® textured breast implants and BIOCELL® textured tissue expanders. 


If you have an Allergan implant, it is important to know that the recall only affects certain styles. Here is a link to the specific styles that have been recalled. *Source: FDA 7/2019


THE FACTS

  1. Breast Implant Associated - Anaplastic Large Cell Lymphoma (BIA-ALCL) is NOT breast cancer. ALCL is a type of non-Hodgkin’s Lymphoma, which is a cancer of the immune system. The risk of BIA-ALCL is very low. Surgical removal of the implant and the capsule (scar tissue that naturally forms around the implant) is often curative. However, some patients may required chemotherapy and/or radiation therapy for treatment.

  2. There are no reported cases of ALCL associated with tissue expanders (temporary breast implants used for breast reconstruction). This is likely due to the fact that tissue expanders are removed within 3-6 months after placement.

  3. There are no confirmed cases of ALCL due to smooth implants (the surface of these implants are NOT textured). Reported cases had incomplete data, unknown implant type, or a history of textured implants.

  4. BIOCELL® is a proprietary implant shell surface created by Allergan. This shell surface is textured as opposed to smooth. Textured implants were designed to prevent future rotation and displacement of the implant, both of which can require re-operation to correct. Textured implants also facilitated the creation of “anatomic” breast implants. These implants are tear-dropped shaped as opposed to round and are intended to mimic the natural shape of the breast. Anatomic breast implants are more commonly used for breast reconstruction following mastectomy.

  5. Both saline and silicone breast implants were offered with the BIOCELL® textured shell. It’s important to know that Allergan manufactures numerous breast implants that are smooth and are therefore NOT included with this recall.

  6. Allergan is NOT the only manufacturer with a line of textured implants. Mentor and Sientra also offer textured implants, although the FDA has not issued a recall of these brands at this time.


WHAT NOW?

If you are considering implant based breast augmentation or breast reconstruction following mastectomy:

  • Allergan smooth implants and smooth tissue expanders are considered to be safe.

  • You might want to consider avoiding textured implants manufactured by other brands.

  • Make sure your surgeon talks with you about the implant type you will receive. You should be confident with your decision and well-informed throughout your surgical process.

If you currently have a tissue expander in place:

  • Try not to worry. Regardless of the type of expander (smooth vs textured) that was placed by your surgeon, all tissues expanders should be removed 3-6 months after placement. Because the expander is temporary, you can assume that your risk is pretty much ZERO. Also, remember that there are NO reports of ALCL associated with tissue expanders.

If you currently have a breast implant:

  • Take a look at the implant information card given to you by your surgeon. This will tell you the implant manufacturer, brand, and style.

  • If you don’t have this card or you’re unsure about the information, contact your surgeon.

 
Here is an example of an implant info card. The style here is SRF: Smooth Inspira Full projection. This implant was NOT recalled.

Here is an example of an implant info card. The style here is SRF: Smooth Inspira Full projection. This implant was NOT recalled.

 

If you currently have a BIOCELL® textured breast implant:

  • Contact your surgeon to discuss your options.

  • Mandatory removal has NOT been recommended because the risk of ALCL is very low.

  • If you have ANY concerns with your implant or breast tissue, you should immediately contact your physician and surgeon.

Possible signs and symptoms associated with BIA-ALCL:

  • Any sudden change in the implant or breast, especially late onset (years after surgery).

  • A new collection of fluid around the implant (i.e. Seroma).

  • Hardening adjacent to the implant.

  • Any mass associated with the implant or breast.

  • Skin changes, such as redness, irritation, thickening.

  • Capsular contraction (a change in the contour, shape, or placement of the implant).

  • A size increase of the breast/implant.

  • Persistent pain associated with the implant.

  • A lump in your armpit area.


To learn more please go the the FDA’s website and read the full press release. If you have any questions or concerns, please obtain a proper medical consultation with your physician and/or surgeon. The information provided here is not a substitute for medial treatment or consultation with a physician. This is intended to help educate the public and structure the conversations your should be having with your healthcare team.