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TEXTURED BREAST IMPLANT RECALL – WHAT YOU NEED TO KNOW

07-30-19 | Posted by


Two little words no woman ever wants to hear in the same sentence are: breast implants and cancer.

After several years of news stories and debate, BIOCELL textured breast implants and tissue expanders made by Allergan under the Natrelle brand were voluntarily recalled. Regrettably, these specific implants have been linked to a rare type of lymphoma known as BIA-ALCL or breast implant associated anaplastic large cell lymphoma. To date, 573 cases have been reported and 481 of these cases were linked to Allergan Biocell implants, according to the FDA.

Sadly, there were 33 deaths among these cases. The FDA also explains that textured breast implants are less common in the U.S. compared to other countries and specifically, the type of textured implant that Allergan manufactures represent less than 5% of all breast implants sold in the U.S. Similar restrictions have been imposed in Canada, France and Australia.

Dr. Charles Thorne in New York City, President of ASAPS, explains further, “As a result of advice from the FDA, Allergan has removed Biocell textured implants and tissue expanders from the market. It is called a “recall” but it is NOT a recall the way most of us understand that term (like when a model of car has faulty brakes and all those cars have to be brought in to the shop). To the contrary, the FDA has recommended that patients with textured implants who have no symptoms should NOT undergo routine removal. Most importantly, patients who do have symptoms from, or concerns about, their implants should contact a surgeon certified by the American Board of Plastic Surgery for advice.”

The ONLY products included in this recall are the following (NOTE this applies ONLY to textured BIOCELL products):

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

According to Dr Alan Matarasso in New York City, President of ASPS, “The American Society of Plastic Surgeons supports Allergan’s voluntary recall of its textured breast implants and tissue expanders. As plastic surgeons, patient safety is always our top priority. ASPS will continue to study BIA-ALCL and provide updated information and resources to physicians and the public. This development underscores the need for plastic surgeons to enter all breast implant cases into the National Breast Implant Registry (NBIR) and ALCL cases into the PROFILE registry.”

If you are at all concerned, or not sure what kind of implants you have, consult with a board certified plastic surgeon to find out more.

 

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