The FDA has asked for, and is getting, a global recall of a widely used type of breast implant, following a big jump in recorded cases of a rare type of cancer.
Allergan has issued a global recall of its BIOCELL textured implants, both the silicone and saline-filled types. They have been linked to a type of cancer, a lymphoma known as ALCL, anaplastic large cell lymphoma.
The FDA says 573 cases of it have been reported worldwide, with 33 deaths.
About 80%, or 461 of those cases are known to involve implants made by Allergan, but in others, they don't know which company made the implant.
Of the 57 cases, 346 cases involve textured implants, 19 involve smooth-surfaced ones, and the surface is unknown in 116 cases.
Local doctors urge women to be aware and informed.
"Most of the conversation up to the past few years for patients has been around what's in the implant," notes Dr. Steven Copit, the chief of plastic surgery at Thomas Jefferson University Hospital.
But now, Dr. Copit says the question of silicone vs. saline has been replaced by concerns about an implant's surface. Textured ones are thought to feel more natural, stay in place better, and cause less scar tissue inside the body.
However, as reported cases of ALCL accumulated in the U.S., doctors and health agencies realized more were occurring with textured implants made by Allergan.
Dr. Pierluigi Porcu of the Sidney Kimmel Cancer Center at Jefferson says in the 8 or 9 cases he's seen, the lymphoma developed over 7 or 8 years, and just around the implant.
"There are collections and clusters of lymphoma cells attached to the implant itself," says Dr. Porcu.
The cancer is rare - about 600 cases among about 11 million women worldwide with implants. And in almost every case, the ALCL stops after the implants are removed.
Researchers don't know specifically how the implants cause the ALCL, however, both Drs. Porcu and Copit think they cause more local inflammation in the breast area than smooth implants.
The FDA and doctors say women don't need to have them removed unless they have symptoms.
"With swelling of one or both breasts associated with the implant, sometimes tenderness, sometimes slight deformation of the shape of the breast," says Dr. Porcu.
These symptoms could show up years after getting the implants.
"Actually, the longer the implants are in, probably the more likely it is that it could happen, although it is very rare," notes Dr. Copit.
Although many doctors in our area use other brands not linked to ALCL, they want women to be informed.
"Make sure they know what type of implant they have in now, whether it's smooth or textured, and the manufacturer," says Dr. Copit.
And Dr. Porcu says women weighing any brand of textured implant should weigh the benefits vs. the risks.
"My own personal bias would be that even though the risk is low, you really have to wonder whether it's worthwhile taking the risk.
The following types have been recalled:
- 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
Textured breast implants recalled after stronger link to rare cancer