Costhetics has vitally important news to share today with anyone considering breast implant surgery.
Allergan, manufacturers of Biocell textured breast implants and tissue expanders, have voluntarily announced a global recall of their products. Here are the facts you need to protect yourself…
Fighting Cancer: Breast Implant-Assisted ALCL
Biocell has been linked to breast-implant-assisted (BIA) anaplastic large-cell lymphoma (ALCL), a cancer of the lymphatic system. The estimated risk of BIA-ALCL is between one-in-1,000 and one-in-10,000. Though relatively rare, of the 573 cases of ALCL evaluated worldwide:
- 481 cases were attributed to the textured implants
- 22 women died from the disease
A 2018 study conducted in Holland estimated the risk of ALCL in women with breast implants to be:
- 1 in 35,000 for women at age 50
- 1 in 12,000 at age 70
- 1 in 7,000 at age 75
“As of April (2019), the TGA had received 76 reports of anaplastic large cell lymphoma associated with breast implants in Australian women,” reported a news article in the Guardian on the subject. Three months later, ahead of the Allergan recall, the TGA proposed regulatory action to protect Australians. Health minister Greg Hunt gave the government’s support to the TGA, which had yet to be finalised and implemented when Allergan stepped up.
Allergan Voluntary Recall & Lingering Questions
Allergan’s recall of its textured breast implants represents a 180-degree change from their original position. Following a request from the U.S. Food and Drug Administration (FDA) to take their product off the market, Allergan initially said, “The company continues to stand behind the benefit/risk profile of its breast implants (including its Biocell products).”
Allergan’s actions have relieved legislators of the need for new laws. Because breast implant-associated ALCL is rare, neither the TGA nor the FDA recommends removal of breast implants in asymptomatic patients. (Allergan further notes that no health authority has called for preventive replacement or removal of the textured implants.)
It should be noted that experts say the recall is only the beginning of an ongoing process. Researchers continue to assess whether the risk of developing ALCL is limited to specific models of textured implants, or whether all textured breast implants may cause problems. Additionally, BreastCancer.org calls for more research into textured implants is required to determine
- Is it wise to leave a non-problematic implant in place in one breast when an implant and tissue capsule were removed because of ALCL in the other breast?
- Is it safe for a patient with BIA-ALCL to replace an implant with a different type of implant?
No Implants for Aussies? Say It Ain’t So!
It ain’t so. The material inside the implant (saline or silicone) does not have an effect on the risk of developing BIA-ALCL. The surface does. That’s where smooth breast implants can be a girl’s best friend. They are prized by many advocates for their soft, fleshy feeling. They tend to last longer than their textured sisters, too, with a lower incidence of leaking. Soft implants also shift within the breast pocket. This allows them to move more like a natural breast. (Textured implants develop scar tissue that anchors them in place.)
Are there any cons to smooth implants? Yes. The same movement that gives smooth implants a natural feel can cause them to slip out of the breast capsule. It should also be noted that not all textured implants will be banned. The research regarding BIA-ALCL has found specific problems with Allergan’s implants, but not all textured implants. For more info on the implants being recalled, head to the TGA’s website.
Don’t Ask Us, Ask Your Doctor
So which breast implant is right for you? That’s the million-dollar question. For that reason, we encourage you to contact your doctor if you have any questions or concerns about current or future implants. Remember, breast implant problems can take years to develop. If you have implants that were placed more than a year ago, run, don’t walk to your doctor if you are experiencing:
Don’t be a boobie. Stay safe and stay beautiful, says Costhetics.