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Local plastic surgeon gives advice on global breast implant recall

Published: Jul. 25, 2019 at 6:36 PM CDT
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LAKE CHARLES, La. (KPLC) - The safety of breast implants is making headlines.

In a news release, Allergan announced a voluntary worldwide recall of its BIOCELL textured breast implants and BIOCELL textured tissue expanders. The company noted the global action as a precaution after being notified of recently updated global safety information concerning the uncommon incidence of Breast Implant Associated Anaplastic Large Cell Lymphoma (BIA-ALCL) provided by the U.S. Food and Drug Administration.

Women with breast implants may have a very small, but increased risk, of developing anaplastic large cell lymphoma or ALCL, in the scar tissue and fluid adjacent to the implant. ALCL is not a breast cancer- it is a rare type of non-Hodgkin’s Lymphoma ( a cancer of the immune system).

Local plastic surgeon, Clyde Smoot said his office has received multiple calls since the FDA released the global recall.

Smoot has performed breast augmentation and reconstructive surgeries in the Lake Area for over 30 years. As of the last 15 years, it you asked him if he’s used textured implants, the response would be no.

“I actually had seen a few cases where patients develop seromas, which is a fluid accumulation around the implant,” Smoot said.

A seroma is a fluid-filled pocket that can develop after surgery.

The FDA has linked Allergan's implants to "significant patient harm, including death."

The agency said that out of 573 Lymphoma cases, 481 are attributed to Allergan implants. Although this cancer is rare, Smoot says he just wants those contemplating surgery to be aware.

“This is not a situation where you need to make the decision right now. You do need to have an increased awareness of this very rare type of cancer and I think make an appointment to see your plastic surgeon so you can sit down and put this into perspective and know what to look for,” Smoot said.

There have also been 33 deaths from the cancer so far, and Allergan had made the implants in 12 out of 13 cases where the manufacturer was known.

Overall, the risk of developing BIA-ALCL is still very small. NPR points out that more than 314,000 people in the U.S. got breast implants in 2018. Textured implants like those recalled are also more common in Europe and Asia than in the U.S.

Warning signs Smoot said to look out for include swelling or pain near the site of your implant.

In a safety communication for patients, the FDA wrote that it does not recommend breast implant removal unless you exhibit symptoms.

The FDA also suggests keeping track of the manufacturer, device identifier, and implant model of your implants.

The risk of BIA-ALCL may be low, but it’s still important to be aware of these concerns. If you have breast implants and you’re concerned about the recall, talk to your doctor.

The recalled products include:

  • Natrelle Saline breast implant styles 168, 363, 468
  • Natrelle and McGhan 410 breast implant styles LL, LM, LF, LX, ML, MM, MF, MX, FL, FM, FF, FX
  • Natrelle and McGhan 410 Soft Touch breast implant styles LL, LM, LF, LX, ML, MM, MF, MX, FL, FM, FF, FX
  • Natrelle 510 Dual-Gel styles LX, MX, FX
  • Natrelle INSPIRA breast implants, styles TRL, TRLP, TRM, TRF, TRX, TSL, TSLP, TSM, TSF, TSX, TCL, TCLP, TCM, TCF, TCX
  • Natrelle and McGhan Round Gel Implants, styles 110, 110 Soft Touch, 120, 120 Soft Touch
  • Natrelle Komuro breast implants styles KML, KMM, KLL, and KLM
  • Natrelle Ritz Princess breast implant styles RML, RMM, RFL, RFM
  • Natrelle 150 Full Height and Short Height double lumen implants
  • Natrelle 133 tissue expanders with and without suture tabs: styles 133FV, 133MV, 133LV, 133MX, 133SX, 133SV, T-133FV,T-133MV, T-133LV, T-133MX, T-133SX, T-133SV, 133FV-T, 133MV-T, 133LV-T, 133MX-T, 133SX-T, 133SV-T
  • Natrelle 133 Plus tissue expander styles 133P-FV, 133P-MV, 133P-LV, 133P-MX, 133P-SX,133P-SV, T-133P-FV, T-133P-MV, T-133P-LV, T-133P-MX, T-133P-SX, T-133P-SV, 133P-FV-T, 133P-MV-T, 133P-LV-T, 133P-MX-T, 133P-SX-T, 133P-SV-T

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