Textured breast implant recalled due to risk of rare cancer: What you need to know
Allergan announced a recall of its BIOCELL textured breast implants and tissue expanders on Wednesday, following a request from the Food and Drug Administration.’ data-reactid=”17″>Pharmaceutical company Allergan announced a recall of its BIOCELL textured breast implants and tissue expanders on Wednesday, following a request from the Food and Drug Administration.
The textured BIOCELL products have been associated with anaplastic large cell lymphoma (BIA-ALCL), according to the FDA.
(MORE: Allergan issues global recall of breast implants linked to rare cancer)‘ data-reactid=”20″>(MORE: Allergan issues global recall of breast implants linked to rare cancer)
This recall does not affect Allergan’s NATRELLE smooth or MICROCELL breast implants and tissue expanders.
BIA-ALCL is a type of lymphoma — a cancer of immune cells. It is not breast cancer.
Even though millions of women have breast implants, only 573 have been diagnosed with BIA-ALCL worldwide, according to the FDA.
“The overall risk for a woman on the high side is about one in 3,800 — and on the very low side the risk is about one in 30,000,” said Dr. Jennifer Ashton, chief medical correspondent for ABC News. “As we say in medicine, the increased risk of a rare event is still a rare event.”
“It’s important to keep this in perspective — it’s a relatively rare complication,” Dr. Oren Tepper, director of aesthetic surgery at Montefiore Health System, told ABC News.
Doctors don’t know exactly what causes BIA-ALCL. One theory is that there is an inflammatory reaction to the surface of the breast implant, causing immune cells to accumulate and become cancerous. Another idea is that the immune system reacts to a bacterial “biofilm” that coats the surface of the implant.
(MORE: FDA launches new campaign aimed at teens about the cost of e-cigarettes)‘ data-reactid=”31″>(MORE: FDA launches new campaign aimed at teens about the cost of e-cigarettes)
The Allergan BIOCELL textured implants have the highest risk of BIA-ALCL, according to the FDA.
The agency’s data suggest that the risk BIA-ALCL with Allergan BIOCELL implants is six times higher than with textured implants from other manufacturers in the U.S., like Mentor and Sientra.
The textured BIOCELL implant has a rough outer shell, which allows it to maintain its shape, versus smooth breast implants which move more freely and feel softer.
Although there is a potential risk with all implants, textured implants are associated with a higher risk of BIA-ALCL when compared to smooth implants, according to the FDA.
The guidance from the FDA is clear: do not remove your implant preemptively.
“Anyone who gets any kind of device or foreign body implanted gets a card from the manufacturer with information on it,” Dr. Ashton advised. “They could also ask their plastic surgeon if they are unsure.”
“Every breast implant has an inventory number — facilities keep it on file and it should be part of your medical record,” said Dr. Tepper.
Like with any surgical procedure, go through the risks and benefits of breast implants with your health care provider. In its guidance, the FDA has emphasized that no matter what type of implant you receive, the risk of BIA-ALCL should be discussed with you.
“The type of implant you have — smooth or textured — is in part a discussion with the healthcare provider, and in part surgeon’s preference — but for now, most surgeons think that the benefits of textured implants don’t outweigh the risk,” Dr. Tepper told ABC News.
“The main take-home: any time you get a medical device implanted in your body, you should find out who makes it, what type it is, what size it is, what the covering is — you need to know everything about it,” Dr. Ashton said.
Source : Link