Recall Alert: Textured Breast Implant Tied To Rare Cancer Taken Off U.S. Market
WASHINGTON (CBSNewYork/AP) -- Medical device maker Allergan Inc. is recalling a type of breast implant linked to a rare form of cancer.
The company Wednesday announced a worldwide recall of implants with a textured surface, reports Dr. Max Gomez.
The U.S. Food and Drug Administration said it called for the removal after new information showed Allergan's Biocell breast implants account for a disproportionate share of rare lymphoma cases.
The move follows similar bans by regulators in France, Australia and Canada, and after nearly 600 cancer cases and 33 deaths have been linked to the implants.
The FDA is not recommending women with the implants have them removed if they are not experiencing problems.
Sandra rush is a grandmother who'd had breast implants for more than two decades with no issues until April of 2017.
"My left breast began to swell, and there was a hardness in it," she said.
What her doctor at first thought was a common infection, turned out to be implant lymphoma.
While any textured implant may theoretically increase the risk for the implant lymphoma, 84 percent of those cases have been attributed to the bio-cell line of textured implants made by Allergan.
"They were thought to reduce the rate of capsular contracture where scar tissue around the implant gets tight and pauinful, that's why they took off," said Dr. Alyssa Golas of NYU Langone Health.
How these implants lead to cancer is not known.
"It is thought that perhaps the implants itself triggers the immune system to react," said Dr. Richard Bakst of Mount Sinai's Ichan School of Medicine. "We know if there is chronic inflammation of any sort, it is a nice backbone for lymphoma to develop.
"In most cases, simply removing the implant in the capsule is the primary treatment," he said. "In more advanced cases, some patients may receive chemo therapy and/or radiation therapy... so the prognosis in most cases is very favorable and it is thought that long-term cure is possible."
According to Allergan's website, the affected products include the following:
- 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
The recalled implants feature a textured surface designed to prevent slippage and to minimize scar tissue. Such models account for just 5 percent of the U.S. market. Most U.S. breast implants are smooth.
(© Copyright 2019 CBS Broadcasting Inc. All Rights Reserved. The Associated Press contributed to this report.)
