PHOENIX (3TV/CBS 5) -- Joanne Chaplin-Shuman survived cancer twice.
More than 20 years ago, she was diagnosed with breast cancer and underwent a double mastectomy.
Her second round of cancer was caused by the breast implants used in her reconstruction.
Joanne says she is horrified by the FDA's recent decision not to ban textured breast implants linked to an increased risk of cancer.
Women fighting for stronger warnings for breast implants believe the number of cancer cases caused by implants is under reported.
[LEARN MORE: Breast implant illness]
Breast Implant-Associated Anaplastic Large Cell Lymphoma is a lymphoma that forms in the scar tissue around a breast implant.
The FDA has 457 verified cases of BIA-ALCL in the United States with nine deaths.
Canada and France have both banned or suspended the sale of textured breast implants because of their increased risk of cancer.
Netherlands did not suspend the use of textured breast implants.
Netherlands Association of Plastic Surgery and Reconstruction advised against using textured implants for some women after breast cancer (Link to full article)-
“As the pathologic mechanism continues to unravel, we will begin to develop a disease profile with established relative and absolute contraindications. A number of cases have recently been linked to women with JAK/STAT acquired and germline mutations46 and with the Li-Fraumeni syndrome, who carry the p53 oncogene mutation.47,48 In such cases, and in women following mastectomy for breast cancer, reconstruction with textured breast implants would be inadvisable.”
For Joanne, it took five doctors and a series of tests to diagnose and treat her BIA-ALCL, despite showing the classic symptoms of pain, lumps, swelling and breast asymmetry.
Two years ago at the age of 74, Joanne was discovered by a modeling agency and even walked the runway in New York Fashion Week. Shortly after her new career started to take off, she could tell something was wrong.
Joanne's symptoms began with a sharp, debilitating pain in her right breast.
After a few painful episodes, she noticed her right breast was swollen, hard and significantly higher than her left breast.
Joanne recalls first going to her family doctor.
"She didn't really know what she was looking at, nor did I," said Joanne.
The family doctor sent Joanne to a plastic surgeon.
"He kept staring at it. You know. Like he's never seen anything like it before," recalled Joanne.
After his reaction, Joanne went back to her family doctor who sent her to a radiologist and surgeon.
They diagnosed her with BIA-ALCL.
Joanne says they came up with a plan to treat her.
"We're going to give you radiation and chemotherapy head to toe. We're going to knock this thing out," they said, according to Joanne.
Prior to starting treatment, the surgeon recommended Joanne see one more surgeon in Scottsdale who previously treated a case of BIA-ALCL.
That surgeon told Joanne he could surgically remove cancer.
"He said, 'I'm going to take care of you. We're going to remove the whole thing. You don't need either radiation or chemotherapy. And you're going to be fine,'" she recalled.
Based on her experience, Joanne believes there are doctors who don't recognize BIA-ALCL when they see it.
There are no requirements for doctors to test for cancer when implants are removed, even if there are symptoms.
In March, the FDA held a public meeting to discuss BIA-ALCL as well as additional risks associated with breast implants.
Women came from across the country to FDA headquarters in Maryland with two main demands.
The first demand is stronger warnings about potential health risks for breast implants. They also wanted a ban on textured implants linked to an increased risk of cancer.
In May, the FDA issued a statement acknowledging women suffering from symptoms including chronic fatigue, cognitive issues and joint and muscle pain may get better if their breast implants are removed.
In that same statement, the FDA said scientific evidence linking textured implants to cancer wasn't strong enough to warrant a ban.
A portion of FDA statement:
"A few of our international counterparts have started to initiate actions to ban or restrict sales of some textured breast implants, based on concerns about BIA-ALCL. In those markets, there are textured implants that are not marketed in the U.S. and where the use of textured implants is much higher, sometimes as high as 80% market share. In 2018, textured breast implants represented less than 10% of breast implants sold in the U.S. The type of macro-textured implants targeted by some of our international counterparts represents less than 5% of breast implants sold here. At this time, the FDA does not believe that, on the basis of all available data and information, the device meets the banning standard set forth in the Federal Food, Drug and Cosmetic Act.
The FDA believes regulatory action must be based on scientific data. While the majority of women who develop BIA-ALCL have had textured implants, there are known cases in women with smooth-surface breast implants and many reports do not include the surface texture of the implant at the time of diagnosis. We are focused on strengthening the evidence generated to help inform future regulatory actions and to assure that women and providers are adequately informed of the risk of BIA-ALCL, including that the risk is higher with the use of textured implants, albeit still low. We are still investigating the cause of the association and we will continue to monitor, assess and report our findings as we continue to strengthen our evidence collected so that women and providers can be better informed about BIA-ALCL as they consider breast implants."
For full FDA statement, go here.
Over the past 20 years, Joanne had 4 sets of breast implants.
The implants removed at the time of her cancer diagnosis were smooth, but she believes at one time, she had a set of textured implants.
Joanne recalls a doctor telling her the implants would stay in place better.
Textured implants are often used for breast reconstruction. Unlike implants with smooth shells, textured implants have a rough outer shell sometimes compared to sandpaper. The texture helps hold them in place.
All implants, textured or smooth, have silicone shells. According to the FDA, an implant's fill (saline versus silicone) doesn't appear to be a factor in the risk of BIA-ALCL.
However, the agency acknowledges cancer occurs more often with textured implants.
Joanne says she is now done with implants and will not have hers replaced.
Her warning to women is that even though the FDA says that type of cancer is rare, she believes women should get stronger warnings.
"It happened to me. It can happen to anyone," Joanne warns.
CBS 5 Investigates reached out to the FDA with the following question:
What immediate actions will the FDA be taking to provide additional information/warnings on the risks of BIA-ALCL to medical community and the public?
Since 2011, the FDA has been providing regular updates on known MDRs regarding BIA-ALCL, and as we noted in our recent statement on breast implants, we are committed to continuing those updates. Similar to our communications in the past when we’ve updated our MDRs on BIA-ALCL, we will continue to publicly share information about any new MDRs we receive on BIA-ALCL. For instance, this past year, we updated our known MDRs on BIA-ALCL and also issued a Letter to Health Care Providers to warn them about the association between all breast implants and BIA-ALCL.
Additionally, as we outlined in our recent statement on breast implants, we are pursuing other actions to ensure patients have complete information about both the benefits and risks of breast implants, including BIA-ALCL. First, we will take steps to improve the information available to women and health care professionals about the risks of breast implants that would include addressing the risk of BIA-ALCL, the greater risk of BIA-ALCL with textured implants, and the risk of developing systemic symptoms that would contribute to the patient-provider discussion about breast implants. We are also looking at ways to incorporate product ingredient information into the labeling in a way that is easy for patients to understand. The FDA would work with stakeholders, including patient groups, on the content and format of any labeling changes proposed or recommended by the FDA, which could include a boxed warning and a patient decision checklist, and would work with manufacturers on implementing any changes to the information they provide to health care professionals and patients, including labeling.