Cook had chemotherapy and then surgery to remove the implants, followed by more chemotherapy. She will be closely monitored for many years to make sure there is no recurrence of the cancer.
“If I had known cancer was linked to implants, I would never have gotten them,” Cook said.
The link between textured breast implants and the disease was first reported in 1997. Since then, about 457 cases have been reported to the Food and Drug Administration and nine people have died of it. (Worldwide, there has been a total of 600 cases and 17 deaths.) Last month an FDA advisory committee met to hear testimony about the safety of implants.
BIA-ALCL is considered treatable if found early enough, with surgery to remove the implants and any masses, and possibly chemotherapy or radiation if the disease has spread.
About 400,000 breast implants are done each year in the United States for post-cancer reconstruction and, much more often, breast enhancement reasons. Implants are either filled with silicone gel or saline solution; their surfaces are smooth or textured. According to Mark Clemens, associate professor of plastic surgery at MD Anderson Cancer Center, only about 12.7 percent of implants sold in the United States are textured, but worldwide the number is closer to 99 percent, although many countries have now banned the textured implants or are phasing them out.
Clemens said the vast majority of implant surgeons were unaware of the disease until January 2011 when the FDA first identified a possible association between textured implants and the development of BIA-ALCL.
“Our understanding is greatly advancing in just the last few years. Today, implant surgeons and oncologists are much more aware of this disease, which is important,” he said, but “we still are focusing on physician and public education on this as much as we can.”
Clemens said most cases can be treated with surgery alone, to remove the implant and scar tissue. He said that 93 percent of women diagnosed and treated are disease-free after three years follow-up. In the U.S. cases where people have died of the disease, diagnosis, and treatment, was significantly delayed on average about two years after symptoms first appeared.
Mark Sisco, chief of plastic surgery at NorthShore University HealthSystem, said that textured implants are used because they can be helpful to hold an implant in place and might reduce scar tissue for some women. He said the textured implants are shaped like a teardrop and theoretically appear more natural. Sisco says he no longer uses textured implants and believes many U.S. surgeons do not now use them.
“I wouldn’t be surprised if the FDA pulls them [textured implants] from the market,” Sisco said.
The FDA has started a patient registry where cases of BIA-ALCL can be reported. Clemens said this should contribute to a better understanding of the causes and treatments.
'I lost my chest'
Amy Rose, spokeswoman for Allergan, one of the manufacturers of breast implants, said the company encourages patients to “have a thorough discussion with their plastic surgeon about the risks and benefits of each implant type to make a fully informed decision.” She said Allergan “supports informed consent for patients, and the company has included appropriate information in the surgeon Directions for Use and patient information leaflets to aid in an effective consultation and patient/physician discussion around the risks and benefits.”
That information specifically warns patients that, “If you have breast implants, you have an increased risk of developing BIA-ALCL,” and it says that for patients “with textured implants, Allergan will cover up to $1,000 of out-of-pocket fees toward diagnostic testing for BIA-ALCL.” If BIA-ALCL is found, Allergan will pay “up to $7,500 of out-of-pocket surgical financial assistance toward the removal of the breast implant(s) and the associated scar tissue.” The company will “also provide replacement implant(s) at no charge” for those diagnosed with BIA-ALCL.
Michelle Forney, 47, had breast implants for about 16 years for cosmetic reasons when she noticed swelling, asymmetry of her breasts and intense itching. The symptoms persisted for at least three years. Her family physician, gynecologist and dermatologist were unable to diagnose the problem.
“I had four mammograms and two ultrasounds in that three-year window” starting in 2015, said Forney, who lives in Sacramento. “Nothing showed up.”
Finally, she opted to have the implants removed. A biopsy done at the time found BIA-ALCL. Based on the advice of cancer experts at the MD Anderson Cancer Center in Houston, she has pursued a “wait and watch” protocol, with regular scans. She is not intending to replace the implants.
Raylene Hollrah was 33 in 2008 when she was diagnosed with breast cancer. After she learned that, she tested positive for the BRCA genetic mutation that has been linked to both breast and ovarian cancer. She underwent chemotherapy and opted for a double mastectomy. Then she had full breast reconstruction, including using textured implants. Five years later, she began experiencing swelling and the implants were removed. Testing confirmed that she had BIA-ALCL. She continues to be monitored with scans for any changes. Like the others, she has chosen not to replace the implants and regrets having used them in the first place.
“I am 40 now and diagnosed with cancer twice,” Hollrah said. “The second one I should never have had.”
Hollrah, Forney and Cook are active in a Facebook group that provides information about BIA-ALCL. All have testified at FDA hearings on the issues.
“I lost my chest, but I have not lost my voice,” said Hollrah, who would like to see the textured implants removed from use.
Both Sisco and Clemens said that women who have implants and are concerned about the possible BIA-ALCL connection should talk to their doctors. They both said that implants are not lifetime devices and that women who have them should keep an eye out for asymmetry or unusual swelling and consult a doctor if such problems develop.
“It is critically important women are aware of this disease but that does not mean they should panic,” Clemens said. “Complications do occur, and a woman can expect to remove or replace them after a decade or two.” Beyond that, he said, in most cases of BIA-ALCL, there is “a very good prognosis.”