Textured Breast Implant

FDA Recalls Allergen’s Biocell Textured Breast Implants

The U.S. Food and Drug Administration (FDA) announced a nationwide, voluntary recall of Allergan’s Biocell textured breast implants on Wednesday, July 24, 2019, because of the risk of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL).

The following Allergen implant products are mentioned in the FDA recall:

  • Natrelle Silicone-Filled breast implants
  • Natrelle Saline-Filled breast implants
  • Natrelle 410 Highly Cohesive Anatomically Shaped Silicone-Filled breast implants
  • Natrelle Inspira Silicone-Filled breast implants
  • Natrelle 133 Plus Tissue Expander
  • Natrelle 133 Tissue Expander with Suture Tabs

The FDA states that there are 573 BIA-ALCL cases around the world and 33 patients have died. Compared to last year’s statistics, there has been an increase of 116 new cases and 24 deaths.

The majority of these cases have occurred outside the U.S. since textured breast implants are not prevalent in this country. In fact, approximately five percent of all implants in the U.S. are textured compared to smooth implants.

BIA-ALCL is an extremely rare cancer of the immune system—not the breast. Plastic surgeons claim that surgery to remove the implant and scar tissue results in a 90 percent cure rate.

There are two types of patients who typically seek textured implants: fitness-oriented patients and patients with sloped ribs.

Women who are bodybuilders, cross-fit competitors, or yoga instructors want implants above the muscle due to their active lifestyles. However, a smooth implant increases the risk of internal scarring around the implant. On the other hand, textured implants reduce such scarring.

When it comes to women with sloped ribs, smooth implants can either fall or slip to the side. Textured implants produce more friction to lock in the same spot.

Common symptoms of BIA-ALCL include pain in the breast, breast enlargement, lump in the armpit or breast, hardening of the breast, overlying skin rash, or a large fluid buildup.

If any of these symptoms are apparent, individuals must take the following steps:

  • Schedule an appointment with your primary care physician
  • Request a physical examination, which includes an ultrasound or a magnetic resonance imaging (MRI)
  • If a mass or fluid is discovered, the doctor will typically request a biopsy

If you have been diagnosed with BIA-ALCL because of textured breast implants, contact our Chicago breast implant attorneys at McNabola & Associates, LLC today at (312) 888-8700 and request a free consultation.