Joce Sterman and Alex Brauer, WJLA: September 16, 2019.
WASHINGTON (SBG) – We’ve all heard of recalls on cars and dangerous toys, but a global recall of a device that’s surgically implanted inside your body has thousands of women on alert. The recall of Allergan’s textured BIOCELL breast implants was prompted by a government analysis that showed an increased risk of cancer. Still, women who have them are generally being told not to have them removed from their chests.
For the last two months, Raylene Hollrah’s email and phone have been blowing up, with hundreds of women contacting her non-profit, dedicated to raising awareness about the emerging cancer. It’s called Breast implant-associated anaplastic large cell lymphoma, also known as BIA-ALCL.
The fear women are dealing with comes following the August global recall of Allergan’s BIOCELL textured implants due to the increased the risk of lymphoma, a cancer of the immune system that Raylene now knows all too well.
When she was diagnosed with BIA-ALCL in 2013, it was a brutal double whammy. Hollrah had survived breast cancer and a mastectomy. During reconstructive surgery in 2008, she got the textured implants that eventually gave her cancer a second time, making her just the 25th documented case of BIA-ALCL in the United States at that time. Her treatment and the research that preceded it came courtesy of Dr. Mark Clemens, who is a pioneer when it comes to researching the disease at MD Anderson Cancer Center in Texas.
In 2017, our Sinclair station in Washington, WJLA/ABC7 was one of the first in the country to tell Raylene’s story and highlight the link between textured breast implants and lymphoma. In that report, reporter Kimberly Suiters pointed out the Food and Drug Administration was aware of 258 confirmed cases of BIA-ALCL. But she said the warnings were not making it to women who might be at risk.
When she was diagnosed with BIA-ALCL in 2013, it was a brutal double whammy. Hollrah had survived breast cancer and a mastectomy. During reconstructive surgery in 2008, she got the textured implants that eventually gave her cancer a second time, making her just the 25th documented case of BIA-ALCL in the United States at that time. Her treatment and the research that preceded it came courtesy of Dr. Mark Clemens, who is a pioneer when it comes to researching the disease at MD Anderson Cancer Center in Texas.
In 2017, our Sinclair station in Washington, WJLA/ABC7 was one of the first in the country to tell Raylene’s story and highlight the link between textured breast implants and lymphoma. In that report, reporter Kimberly Suiters pointed out the Food and Drug Administration was aware of 258 confirmed cases of BIA-ALCL. But she said the warnings were not making it to women who might be at risk.
Allergan voluntarily pulled the implants as well as its related tissue expanders from the market, but they remain in thousands of women, many of them breast cancer survivors. And while a letter obtained by Spotlight on America shows the company is offering free replacement implants, it won’t pay for revision surgery.
The letter explains the decision not to cover surgical fees is in line with an FDA recommendation that textured implants not be removed in patients who have shown no symptoms of BIA-ALCL. The FDA is telling doctors to stop using the implants but has told women they can keep the implants if they’re not symptomatic.
Diana Zuckerman with the National Center for Health Research says, “Some of the women are going to say I don’t care what the FDA says, I’m getting them out.”
Zuckerman explained the FDA’s advice to keep the implants balances the risks of surgery with the chances of getting this type of lymphoma, which is rare. BIA-ALCL is also highly treatable and Zuckerman says removing the implants before a woman is diagnosed with BIA-ALCL is not a 100% guarantee that she won’t develop the disease.
And there’s another big question following the recall: exactly who has these implants? Zuckerman says many women don’t know and may struggle to find out as doctors don’t have to keep these records permanently.
That’s a big deal considering it could take years for this kind of cancer to develop. For Raylene Hollrah, her BIA-ALCL diagnosis came five years after she had her implants placed. After cancer a second time, she had them removed permanently. Now Hollrah has become an advocate for women in this same situation, making sure they know about BIA-ALCL.
So far no one has firmly pinpointed why these implants are a cancer risk, although many theories exist. And while the recall right now is only for Allergan’s BIOCELL textured implants, the FDA said it, “will continue to evaluate any new information and may, as a result, take action regarding other breast implants, if warranted.”
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Read the full article here.