In the U.S., the lifetime risk of developing ALCL is low, according to Clemens: 1 in 30,000. But in Australia, it’s 1 in 1,000. Tomes believes the hard-to-believe statistical difference proves that the disease is under-reported. Plastic surgeons say they are eager to find out why so they can inform responsibly and accurately.
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7 On Your Side submitted the following questions to Allergan:
- To the extent that it is possible, will Allergan track down, or ask surgeons to track down, every woman who received textured breast implants to inform them of the small but potential risk of BIA-ALCL?
- What is Allergan’s plan moving forward to help educate women and physicians about the issues regarding textured breast implants and ALCL? If an information campaign is in the works, please share the details.
- Is Allergan currently researching possible causation between textured breast implants and ALCL? When will results be released (whether to the FDA, ANSM, or the public at large)?
- Do you consider ALCL to be exclusive to the textured implants? If yes, what is it about texturing that appears to be problematic?
- How many cases of ALCL did you discover prior to adding it to your label, and when was it added?
Allergan’s Marmur replied to our questions with a statement, which is published in full below:
ALLERGAN STATEMENT
”Patient safety is always Allergan’s first priority. However rare, Allergan takes this disease seriously.
According to the FDA, BIA-ALCL has been reported in patients with textured breast implants from all manufacturers. Because of the limited number of confirmed BIA-ALCL case worldwide, the medical community has not been able to establish causality.
Allergan is actively working to help advance the knowledge of this disease, understand the association of BIA-ALCL and textured implants, and educate the community, including:
- Working closely with the FDA and global regulatory bodies to ensure that our products’ labeling documents include all information necessary for healthcare professionals and patients. This includes safety data, precautions, warnings, potential side effects. In addition, Allergan has added information on BIA-ALCL as a rare adverse event into the patient literature that accompanies every pack of implants in the US and internationally.
- Convening global medical experts and researchers to foster collaboration and advance the medical community’s knowledge and awareness of the disease. Allergan also has conducted surgeon education meetings and webcasts in the US and internationally since 2014.
- Working closely with FDA and other regulatory authorities to submit all reports of BIA-ALCL annually. Please see the FDA’s web site for additional information: http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm240000.htm#howtoreport;
- Supporting ongoing research to ensure physicians and patients have the latest scientific findings to appropriately diagnose and effectively treat the disease, ensuring women are appropriately informed, monitored, and managed if diagnosed with BIA-ALC.
- Partnering with ASPS, ASAPS and ISAPS to distribute BIA-ALCL educational materials and work with these societies on guidance for healthcare professionals regarding the appropriate management of patients.
Women with breast implants should be advised to perform regular breast self-examination, and consult their healthcare provider if they notice changes such as, swelling, pain, lumps, or asymmetry.”