FDA releases safety alert about textured breast implants
A consumer health warning for women with textured breast implants.
After a safety alert from the food and drug administration, it strengthens a controversial opinion about whether the implants themselves can cause cancer.
Kimberly Suiters from our sister station in Washington D.C. shows us why.
Breast cancer survivor Raylene Hollrah claims she was never warned that the textured implants she chose for reconstructive surgery in 2008 could give her cancer a second time.
“I did everything to keep cancer away, yet I put a device in my body that caused cancer,” said Hollrah.
In 2011 the FDA identified an association between breast implants and lymphoma. In response, the American Society of Plastic Surgeons developed a database to track Breast Implant-Associated Anaplastic Large Cell Lymphoma cases.
Implant manufacturers included the FDA safety communication warning in the packaging for their products - packaging not seen by patients.
But in 2013 when her right breast tripled in size in a matter of days and Hollrah became the 25th documented case in the U.S, she had never heard BIA-ALCL.
“It makes me mad. I say now I’ve lost my chest but not my voice,” said Hollrah.
Hollrah created a foundation that calls for mandatory warnings for women who already have the implants and those who will get them.
"This has created a certain amount of anxiety and concern among the medical community,” said Dr. Mark Clemens.
Dr. Clemens is one of the world's experts on BIA-ALCL.
His research and others show three-quarters of surgeons are not discussing that particular risk with patients.
In the U.S., the lifetime risk of developing ALCL is low.
According to Dr. Clemens, at worst, 1 in 30,000, but in Australia, 1 in 1,000.
Surgeons say they want to inform not frighten.
In 2016, the FDA acknowledged a four-fold increase in reports in five years.
For the first time, the World Health Organization recognized BIA-ALCL as a new lymphoma. The national comprehensive cancer network developed the first international standard for its diagnosis. And a French agency warned there exists a "clearly established link" between implants and cancer.
For these reasons, one of the country's leading advocates of breast implants, rarely uses textured implants, and always discusses the risk.
Allergan, one of the manufacturers of textured implants, declined an on-camera interview, but gave a 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."
When our sister station asked again for direct answers to our questions, we received the following responses from Frances DeSena, Vice President, US Brand & R&D Communications for 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?
"Allergan continues to provide educational information regarding this disease to both physicians and patients, as well as working with the FDA and regulatory authorities to collect and assess safety reports to help inform the physician community, regulatory agencies and patients on the appropriate use of our implants. The surgeon and patient FDA-approved labeling for Allergan’s breast implants – as well as the labeling documents of all other breast implant manufacturers – discusses BIA-ALCL. Both the FDA and the leading plastic surgeon societies (ASPS and ASAPs) encourage routine breast care and support for patients who have received breast implants:
“Healthcare Providers: If you have patients with breast implants, you should continue to provide them routine care and support. ALCL is a very rare condition; when it occurs, it has been identified most frequently in patients undergoing implant revision operations for late onset, persistent seroma. Because it has generally only been identified in patients with late onset of symptoms such as pain, lumps, swelling, or asymmetry, prophylactic breast implant removal in patients without symptoms or other abnormality is not recommended.”
ASPS and ASAPS state: “Expert opinion is that asymptomatic women without breast changes do not require more than a routine follow-up."
Allergan supports the recommendations of the FDA and ASPS/ASAPS."
6) How many cases of ALCL did you discover prior to adding it to your label, and when was it added?
"Manufacturers have been reporting cases of BIA-ALCL as they have occurred, leading to FDA’s press release in 2011 informing the public of the potential association between breast implants and the development of ALCL. Then, US breast implant manufacturers worked with FDA to develop language to be included in approved labeling documents, which were released in 2013. Allergan complies with applicable regulations relating to the reporting of BIA-ALCL to the FDA. The FDA has a webpage devoted to reports of ALCL it receives from breast implant manufacturers, which includes the date range of the reports, information regarding the type of implants, whether the surgery was for reconstruction or augmentation, etc.