Breast implant maker tries new push to find patients one year after cancer related recall

By: JOCE STERMAN and ALEX BRAUER, Sinclair Broadcast Group

From: wjla.com

One year after voluntarily recalling textured breast implants shown to have a potential link to cancer, Allergan is making a new push to track down thousands of women who may not be aware of the risk.

For years, Raylene Hollrah has been sounding the alarm about a rare type of cancer linked to breast implants. It’s called breast implant-associated anaplastic large cell lymphoma, or BIA-ALCL. “Women need to know. On our platform we’ve been shouting it from the rooftops,” she said.

Hollrah battled BIA-ALCL back in 2013. The diagnosis was a double whammy, given she had gotten implants following a double mastectomy after overcoming breast cancer. After beating the disease, Hollrah became focused on awareness, making sure women knew about BIA-ALCL and the risks associated with specific implants.

Spotlight on America first shined a light on this issue last summer when the Food and Drug Administration requested a company called Allergan recall its BIOCELL textured breast implants because of a link to BIA-ALCL. The recall followed reporting by our Sinclair station in Washington, WJLA, which was one of the first media outlets in the country to tell Raylene’s story and highlight the link between textured breast implants and lymphoma back in 2017.

At the time of the recall, the FDA said it was aware of nearly 500 cases of BIA-ALCL and at least 12 deaths tied to Allergan textured implants. And on the day of the July 2019 announcement, the FDA’s Commissioner tweeted, “While the risk of BIA-ALCL is low, once the evidence indicated that Allergan’s textured breast implants appeared to be directly linked to significant patient harm, including death, we took action to protect women’s health.”

Allergan, which was acquired by biopharmaceutical company AbbVie in May 2020, stopped making and selling the products after the voluntary recall. On its website, the company says, “We took this action following notification by the U.S. Food and Drug Administration of their recently updated global safety information. This information showed an association between breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) and Allergan BIOCELL textured breast implants.”

But Hollrah worries thousands of women still have the implants in their chest. And they may have no idea about the recall or the cancer connection.

Allergan says it has made robust efforts over the past year to reach women following the recall, but the company is still looking for thousands of patients because it says it doesn’t have tracking data for as many as 52,000 implants. In June the company announced a new campaign to further identify women who may not know the risk they’re carrying.

“Allergan Aesthetics is committed to patient safety and we are continuing to make every effort to make sure that each and every patient is made aware of the BIOCELL recall, and knows their implant type and implant history,” said John Maltman, Vice President of Medical Affairs at Allergan Aesthetics in a press release about the campaign.

Hollrah, while glad to see further action taken to inform women, believes wider outreach efforts should have been done sooner. “It took you a year to do something about it. I think the reaction is very slow. It’s just frustrating.”

In its announcement nearly two months ago, Allergan said it was launching digital and social media ads to inform patients. But Spotlight on America found no mention of the campaign on the company’s Twitter, Instagram, YouTube, Facebook or home page. After repeatedly asking for copies of the campaign materials, Allergan supplied a single screenshot of a campaign ad. The company declined our request for an interview.