Hometown girl takes on FDA . . . and WINS!

Raylene Hollrah has been fighting for quite a while now. She has been cancer free for six years, but since beating her initial go-round of breast cancer, she has been fighting to eliminate the cause for her second round. 

“I got cancer from my breast implant from [reconstructive surgery] on my breast cancer journey,” she said. “I was number 25 in the U.S., number 61 in the world to be diagnosed with it (breast-implant-associated anaplastic large cell lymphoma).”

She said her doctors at M.D. Anderson told her they thought there were thousands of women out there with BIA-ALCL. That’s when she contacted the U.S. Federal Drug Administration (FDA) to take on the Dublin, Ireland-based Allergan—“a bold, global pharmaceutical leader focused on developing, manufacturing and commercializing branded pharmaceutical, device, biologic, surgical and regenerative medicine products for patients around the world (allergan.com).”

They make Biocell-branded textured breast implants. The rougher surface is designed to adhere to surrounding tissue and make them less likely to become repositioned than smooth breast implants.

According to an Allergan securities filing (they were recently sold to AbbVie, Inc.) there are more than a dozen lawsuits filed against Allergan in both U.S. and Canadian courts that allege their textured breast implants caused women to develop lymphoma. It was also stated Allergen was alleged to have been cavalier with warnings and failed to promptly and properly report the results of certain studies relating to their products. 

According to the FDA, there have been 573 cases of BIA-ALCL reported, resulting in 33 deaths. The FDA attributed 84% of the 573 cases to Allergan implants.

The Wall Street Journal reported the FDA, as early as last Feb. was hesitant to contact Allergan about banning their products because there wasn’t sufficient evidence. 

“Instead, the FDA tightened the requirements for implant manufacturers to report health problems in patients receiving them.”

In the meantime, Raylene was relentless in getting the FDA’s ear. 

“I’ve testified four times before the FDA,” she said. “The first time, was with three other people by my side, the second time, five, then 25.”

In February, the agency said there were 457 cases including nine deaths. Since that time, the FDA became alarmed with the number of cases reported (573) and the number of deaths (33), showing significant increases, prompting the ban and recall of a list of textured implants and tissue expanders, the balloon-like sacs that are slowly expanded with saltwater to stretch the skin so the permanent implant can be inserted later. 

“This past March, we went [to testify] and there were a thousand of us,” said Raylene. “The FDA heard us loud and clear and it’s going to save lives.”

Raylene says she takes on the good fight every day for the 33 women that have lost their battles.

“I do it everyday for my daughter, who will be tested for the breast cancer gene mutation when she turns 18 years-old,” she continued.

“They (textured implants) are being recalled and they will never be put in a woman’s body again,” she stated flatly.

She won a fight, and yet, she’s grateful and humbled.

“I’m thankful for the support from this awesome town,” she shared.

The FDA says hundreds of thousands of women received these Allergan implants. On a conference call with reporters, Amy Abernathy, the FDA’s principal deputy commissioner said, “While the overall incidence appears to be relatively low, once the evidence indicated the Allergan product was linked to patient harm including deaths, the FDA took action.”

It’s bittersweet for Raylene. After all, the FDA first reported a possible link between breast implants and anaplastic large cell lymphoma in 2011.

The American Cancer Society suggests for those that have breast implants, to continue  their regular, routine medical care and follow-up. The FDA isn’t recommending removal of implants in patients without symptoms because the risk of developing lymphoma is low and there are safety risks associated with removal. 

“We still have a lot of work to do—there’s still thousands of women out there with these implants in their body and we need to make sure the recall and followup with these patients is done correctly,” she said.

“Along with the help of many others, this small-town girl has taken down a big old pharmaceutical company. We did it.”

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