In 2016, Jennifer Cook, a Californian teacher who had had breast implants in 2010, noticed a change in one of her breasts. So when a play she was attending with her class had a line about breast cancer and implants, she was getting nervous.
After a quick search online, revealing scary stories, she was scanned and quickly learned that she had four masses around the implant – two of which were behind the implant, and therefore not palpable and not visible on a regular mammogram or ultrasound. He was diagnosed with a syndrome called anaplastic large cell lymphoma associated with a breast implant, or BIA-ALCL.
Cook underwent chemotherapy and then surgery to remove the implants, followed by additional chemotherapy. She will be closely monitored for many years to make sure that cancer will not happen again.
"If I had known that cancer was related to implants, I would never have had them," Cook said.
BIA-ALCL is a rare type of non-Hodgkin's lymphoma, a cancer of the cells of the immune system. It can occur in different parts of the body, including lymph nodes and skin. Although BIA-ALCL is found in the breasts of some people with breast implants, it is not specific to breast cancer.
The link between textured breast implants and the disease was reported for the first time in 1997. Since then, approximately 457 cases have been reported to the Food and Drug Administration and nine people have died. (Worldwide, there were a total of 600 cases and 17 deaths.) Last month, an FDA advisory committee met to hear evidence on implant safety.
BIA-ALCL is considered treatable if it is found early enough, with surgery to remove implants and any mass, and possibly chemotherapy or radiation therapy if the disease spreads.
Approximately 400,000 breast implants are performed each year in the United States for post-cancer reconstruction and, more often, for breast enhancement. 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 the MD Anderson Cancer Center, only about 12.7% of implants sold in the United States are textured, but this figure is closer to 99% worldwide. However, many countries have already banned textured implants. are in the process of eliminating them.
Clemens said that 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 has come a long way in recent years. Today, implant surgeons and oncologists are much more aware of this disease, which is important, "he said, but" we always focus as much as we can on the disease. " educating doctors and the public about it.
Clemens said that most cases can be treated by surgery alone, in order to remove the implant and scar tissue. He said that 93% of women diagnosed and treated are disease free after three years of follow-up. In the United States, when people died as a result of the disease, diagnosis and treatment were significantly delayed on average about two years after the first onset of symptoms.
Mark Sisco, head of plastic surgery at HealthSystem of NorthShore University, said textured implants are used because they can be helpful in keeping an implant in place and could reduce scar tissue in some women. He added that the textured implants were shaped like a drop of water and seemed theoretically more natural. Sisco says he no longer uses textured implants and thinks many US surgeons are not using them now.
"I would not be surprised if the FDA attracted them [textured implants] of the market, "said Sisco.
The FDA has launched a patient registry in which cases of BIA-ALCL can be reported. Clemens said this should contribute to a better understanding of causes and treatments.
"I lost my chest"
Amy Rose, a spokesperson for Allergan, one of the breast implant manufacturers, said the company encourages patients to "have a thorough discussion with their plastic surgeon about the risks and benefits of each type of implant. to make an informed decision. " "Supports the informed consent of patients and the company has included the appropriate information in the surgeon's instruction manual and patient information brochures to facilitate effective consultation and patient / physician discussion on risks and benefits ".
This information specifically warns patients that, "if you have breast implants, you have an increased risk of developing BIA-ALCL," and indicates that for patients "with textured implants, Allergan will cover up to $ 1,000 expenses paid. to diagnostic tests for BIA-ALCL. If BIA-ALCL is detected, Allergan will provide "surgical funding of up to $ 7,500 for the removal of breast implants and associated scar tissue." The company will also provide "free replacement implants" for those diagnosed with BIA-ALCL.
Michelle Forney, 47, had breast implants for about 16 years for aesthetic reasons when she noticed swelling, breast asymmetry and intense itching. The symptoms persisted for at least three years. His family doctor, gynecologist and dermatologist were unable to diagnose the problem.
"I've had four mammograms and two ultrasounds in this three-year window" as of 2015, said Forney, who lives in Sacramento. "Nothing has appeared."
Finally, she opted for removal of implants. A biopsy performed at the time revealed BIA-ALCL. On the advice of cancer experts at the MD Anderson Cancer Center in Houston, she has put in place a protocol for waiting and monitoring, with regular scans. She does not intend to replace the implants.
Raylene Hollrah was 33 years old in 2008, the year of the breast cancer diagnosis. After learning this, she was tested positive for the BRCA genetic mutation that has been linked to breast and ovarian cancers. She underwent chemotherapy and opted for a double mastectomy. Then she had a complete breast reconstruction, including using textured implants. Five years later, she began to have swelling and the implants were removed. The tests confirmed that she had BIA-ALCL. She continues to be monitored with scans for any changes. Like the others, she chose not to replace the implants and regrets having used them in the first place.
"I'm 40 now and have been diagnosed with cancer twice," Hollrah said. "The second one I should never have had."
Hollrah, Forney and Cook are active in a Facebook group providing information about BIA-ALCL. All testified at FDA hearings on these issues.
"I lost my chest, but I did not lose my voice," said Hollrah, who would like to see the textured implants removed from use.
Sisco and Clemens both said that women who have implants and who are worried about the possible BIA-ALCL connection should talk to their doctor. They both said that implants are not lifelong devices and that women who have them should keep an eye on asymmetry or unusual swelling and consult a doctor if such problems develop.
"It's extremely important that women be aware of this disease, but that does not mean that they should panic," Clemens said. "There are complications and a woman can expect to remove them or replace them after a decade or two." He added that in most cases of BIA-ALCL, there is "a very good prognosis ".