Doctors, patients warn about cancer linked to textured breast implants

Experts believe there's an interaction between a woman's body and the implants, which have a suede-like coating.

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/ Source: TODAY
By Lauren Dunn, Vicky Nguyen and A. Pawlowski

Raylene Hollrah is on a mission to save women who are considering textured breast implants from the ordeal she has endured.

“I always say I lost my chest, but I haven't lost my voice,” she told TODAY.

Raylene Hollrah is trying to raise awareness about for breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) after being diagnosed with the disease.Courtesy Raylene Hollrah

The 46-year-old mother of two from Missouri had to undergo five months of treatment for breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). It’s not breast cancer, but a type of non-Hodgkin's lymphoma.

Since 2011, there have been 457 cases in the U.S. linked between textured breast implants and the disease, according to the Food and Drug Administration. Nine women have died.

Hollrah received her implants after surgery for breast cancer 13 years ago.

“I was sold on the fact that this was newest to the market and approved by the FDA — the safest textured implant on the market,” she told NBC News Investigative and Consumer Correspondent Vicky Nguyen.

But almost seven years later, her right breast filled with fluid and swelled to three times its normal size.

"I saw my doctor and I knew something was wrong. He informed me that I had cancer again,” Hollrah recalled. After researching her diagnosis, she called it “a man-made cancer.”

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Hollrah now runs a website and Facebook page dedicated to raise awareness about the issue, and gets 20 messages a day from concerned women.

In March, the FDA said BIA-ALCL is most likely caused by textured breast implants, which have a suede-like coating. But the agency stopped short of taking the implants off the market, noting it wanted to continue studying the disease and tracking cases. It’s estimated that of the 400,000 women who get breast implants each year, about one in 10 has textured implants.

Dr. Elisabeth Potter, a plastic surgeon specializing in breast reconstruction in Austin, Texas, said she's heard from hundreds of women in the past three months who want their textured implants removed.

“The textured surface is almost like a tiny Velcro. It grows into the woman's body. I believe that that's the source of the breast implant-associated lymphoma because there's an interaction between the woman's body and the implant,” Potter said.

The latest FDA statement says the risk of developing BIA-ALCL in women with textured breast implants ranges from one in 3,817 to 1 in 30,000 based on studies reported in medical literature.

But an NBC News investigation in partnership with the International Consortium of Investigative Journalists last fall reported the cancer could be much more common than first thought — as high as one case out of every 1,000 women with breast implants, according to Australian health officials. The FDA said the implants available in Australia are different from those sold in the U.S., which complicates efforts to figure out the true risks.

Since that report, 38 countries have pulled one brand of implants, Allergan, off the market. All brands are still sold in the U.S.

In a statement, Allergan said patient safety remains the company's highest priority.

"Allergan continues to stand behind the benefit/risk profile of its products. The safety profile of Allergan's breast implants is supported by extensive pre-clinical device testing, more than a decade of worldwide clinical use, and a large number of peer-reviewed published studies," the statement read.

Two other implant makers, Mentor and Sientra, also stood by their products.

"We believe MENTOR Textured Breast Implants are an important option for women who are considering breast reconstruction following mastectomy or for those considering augmentation because they have certain advantages over smooth implants," Mentor said in a statement.

"The long-term safety and effectiveness of our breast implants is supported by more than a decade of clinical data and peer-reviewed studies," Sientra said in a statement.

But some doctors are in favor of pulling textured implants from the market.

“I think that the implants shouldn't be on the market unless the FDA can say to women, ‘We know that there's no increased risk of cancer with this implant,’” Potter said.

Hollrah agreed.

“Everybody's looking for a cure for cancer, we can cure this cancer. They need to be removed from the market,” she said.

In a statement, the FDA said it has been tracking the potential risk of certain types of breast implants “carefully and closely for many years.”

“The FDA is increasingly concerned about the potential BIA-ALCL risk for women with certain textured breast implants. Our experts have been reviewing new information presented since the public advisory committee meeting in March. We intend to update the public shortly with the findings of our analysis,” the agency said.

Hollrah is now working with the FDA to require a "black box" warning for these implants to force makers to disclose the cancer risks, similar to the warnings added to packs of cigarettes.

If you have breast implants:

  • There is no need to change your routine medical care and follow-up, the FDA says.
  • Go to your doctor if you notice something unusual, such as new swelling, lumps, an unexplained rash or pain around breast implants.
  • The majority, or 80%, of women with breast implant-associated ALCL will have a “spontaneous fluid collection,” which may show up as a sudden enlargement or swelling of the breast, Dr. Mark Clemens, associate professor of plastic surgery at The University of Texas MD Anderson Cancer Center in Houston, told TODAY. About 40% will feel a mass or a lump.
  • One part of the diagnosis is a screening test called CD30. If you don’t get that test, you can miss the disease, Clemens said.
  • The treatment for the vast majority of patients is surgery. If the disease progresses to the lymph nodes, it usually requires chemotherapy.