Woman who beat breast cancer once says breast implants caused cancer again
WASHINGTON (ABC7) —
In a Safety Alert issued by the FDA in March of 2017, the government agency strengthened its position on whether implants can cause lymphoma. Initially the FDA had reported only a possible association, but the recent update strengthens that language, saying ALCL can develop following breast implants. This position aligns the FDA with the World Health Organization’s view; but stops short of the FDA’s counterpart in France which called it a “clearly established link.” The alert also indicated, for the first time, that textured implants, rather than smooth implants, tend to be cited more often as problematic. The number of cases reported to the FDA has risen by 100 since 2015, but the agency and health statisticians acknowledge that the numbers are likely underreported worldwide.
"You have cancer — again."
"What? Breast cancer?"
"No ... a new one."
So went the conversation between a stunned 40-year-old Raylene Hollrah and the plastic surgeon who performed her reconstructive surgery after she HAD survived breast cancer seven years earlier.
Her new cancer diagnosis? Breast Implant-Associated Anaplastic Large Cell Lymphoma, or BIA-ALCL for short. Of all the potential side effects of breast implants, she did not recall her surgeon ever mentioning a small but increased risk of cancer.
“I did everything to keep cancer away,” Hollrah told 7 On Your Side. “Yet, I put a device in my body that caused cancer.”
THE PATIENT: “I didn’t choose cancer, either time.”
The US Food and Drug Administration is not prepared to say that the textured breast implants Hollrah chose cause lymphoma, a cancer of the immune system.
But in 2011 and again in 2016, the FDA cautioned of a “possible association” between ALCL and implants.
Implant manufacturers included the FDA safety communication in its packaging, something surgeons would see but not patients. The manufacturers also started to include the information on their websites.
But in 2013, when Hollrah’s right breast tripled to an alarming size in a matter of days, she became the 25th documented case in the U.S. She had never heard of ALCL.
“No one ever warned me,” Hollrah said. “It makes me mad. I say now, 'I've lost my chest but not my voice.'”
She created a foundation, Just Call Me Ray, which pushes for mandatory warnings for women who will not only get the implants but who already have them. She calls the effort “implanting awareness.”
THE SURGEONS: “It has to be worth it.”
“This has created a certain amount of anxiety and concern among the medical community," said Dr. Mark Clemens of MD Anderson Cancer Center, one of the leading experts on ALCL in the world.
Clemens met Hollrah after her diagnosis, explanted her implants and asked her questions about what she was told and when. His research, and others of patients and surgeons, reveals that patients never think to ask about ALCL and only one-quarter of surgeons always discuss the risk with patients in the initial consultation.
“We would like surgeons to always discuss the small, rare, but potential risk of this serious disease,” said Clemens, who serves on the board of the American Society of Plastic Surgeons (ASPS) as the liaison to the FDA. ASPS urges its board-certified members to always talk to patients about the risks as part of the informed consent process.
When 7 On Your Side filed a Freedom of Information Request (FOIA) about ALCL cases reported to the FDA, we received more than 800 documents representing 441 cases, more than one-third unconfirmed, and at least 12 deaths. Even since the 2011 advisory from the FDA about ALCL and implants, when manufacturers responded to reported adverse events, they often listed many risks but didn’t include ALCL.
“They should. Absolutely,” said Madris Tomes, CEO of Device Events, and a former FDA analyst who managed the build of a new adverse event reporting system. Tomes looks for patterns of problems with medical devices, but spotty reporting makes pinning down exact numbers for ALCL tricky.
Take, for example, one report to the FDA of an “injury” after the patient with breast implants developed lymphoma and died.
“The cause was ‘patient device incompatibility,’” pointed out Tomes. “The findings here indicate an ALCL diagnosis, but that didn't show up as death because they didn't check the death box.”
“The FDA website had the product safety data sheets for the silicone and saline breast implants on the market but over half of the links are outdated and do not contain any information on BIA-ALCL,” complained Jamee Cook, the founder of a Facebook support group titled ALCL In Women With Breast Implants BIA-ALCL. The group has nearly 400 members, with 30 claiming to be diagnosed, and two who lost their mothers to ALCL.
“When researching, you would have to dig around on the manufacturers' sites to get the most updated version that does contain that warning," Cook said.
In the U.S., the lifetime risk of developing ALCL is low, according to Clemens: 1 in 30,000. But in Australia, it’s 1 in 1,000. Tomes believes the hard-to-believe statistical difference proves that the disease is under-reported. Plastic surgeons say they are eager to find out why so they can inform responsibly and accurately.
“Are you concerned about ALCL?” 7 On Your Side asked Dr. David Song, Region Chief of MedStar Plastic Surgery and Chairman of the Department of Plastic Surgery at Georgetown University School of Medicine.
“As of today no,” said Song. “It's still an extremely rare situation. You don't want to yell 'fire' in a theatre when there's no fire.”
Song and many plastic surgeons who spoke to 7 On Your Side, expressed deep concerns about unnecessarily scaring women and limiting their options, which many of them believe was the case when silicone breast implants came under fire and caused a health scare in the early 1990s.
Whether silicone or saline, Song explained why patients choose textured implants. They have a more natural, teardrop look, thinner at the top, thicker at the bottom. Texturing is intended to keep them from rotating. Researchers are evaluating whether that texturing, or a bacteria, or genetics make a patient more vulnerable to developing lymphoma.
“Is there some belief that rubbing creates this lymphoma?” 7 On Your Side asked Song.
“We don’t know what creates this lymphoma,” said Song.
We’re getting closer to the truth. In 2016, for the first time, the World Health Organization recognized BIA-ALCL as a new lymphoma. The National Comprehensive Cancer Network developed the first international standard for its diagnosis. A French health agency issued the strongest warning yet, that there exists “a clearly established link,” between implants and cancer.
For these reasons, one of the country’s leading advocates of breast implants, Dr. Scott Spear in Chevy Chase, rarely uses textured implants, and always discusses the risk.
“Although it's rare,” said Spear. “It's a risk people need to know they are taking and it has to be worth it.”
7 On Your Side first interviewed Spear for a report on the increased risk of suicide after implants. While he dismissed the research backing that claim, he insisted that this connection is “special” and “deserves our attention.”
Hollrah would have liked to have known all of it.
“People say, ‘You chose the implant.’ But I didn't choose cancer, neither time,” Hollrah said. “I can assure you, if I had choice, and I knew that the implant I was about to put in my body could give me cancer, that's a choice.”
THE MANUFACTURER: “Allergan takes this disease seriously.”
Hollrah’s textured implant, and the implant that shows up most often in FDA adverse reporting records regarding ALCL, was made by Allergan.
She and another implant patient, Michelle Mays, a health care provider who wrote to 7 On Your Side after learning we were researching the topic, both participated in Allergan studies about textured implants, but were told that the studies were dropped. Mays said the study was supposed to span 10 years, she would be paid $200 to $300 each time she returned to the surgeon and reported back, essentially reimbursing her for the extra $2,000 she paid to get textured implants.
“After two years, I called the plastic surgeon’s office and they said they were no longer in the study and good luck,” wrote Mays.
One patient who chose to have her implants removed, and asked to remain anonymous, showed 7 On Your Side emails from the FDA explaining that three case-controlled studies by three manufacturers investigating five rare disease outcomes, including lymphoma, were all terminated:
7 On Your Side asked Allergen to respond and explain why their study appeared to be terminated. Frances DeSena, Vice President, US Brand & R&D Communications for Allergan responded:
"Upon receiving approval for the Natrelle 410 breast implant, Allergan was required to conduct post-approval follow-up studies of approximately 3,500 patients who were enrolled in the 410 clinical study. These studies were part of the normal FDA approval process for breast implants and were not specific to BIA-ALCL. Allergan fulfilled all of its post-approval commitments in 2014 and requested FDA’s approval to discontinue the studies early in light of Allergan meeting all post-approval commitments. FDA approved Allergan’s request and the studies were discontinued in 2014. The discontinuation of these post-approval studies had nothing to do with BIA-ALCL. Allergan complied with standard protocols and regulations relating to the termination of the studies, which included proper notification to the trial sites and the Institutional Review Boards.
The link to the FDA website provided below is to a Natrelle 410 case-control study that Allergan never conducted because FDA ultimately deemed it unnecessary. The case-control study was designed to evaluate several rare diseases, including rare CTDs, rare neurological diseases, brain cancer, cervical/vulvar cancer, and lymphoma.
Lastly, to reiterate, Allergan has a robust post-market surveillance process (e.g., collecting reports of BIA-ALCL from surgeons, notifying FDA and other international regulatory agencies of all suspected cases, monitoring literature and case presentations, etc.) to monitor and report suspected cases of BIA-ALCL."
The patient also learned that the manufacturers collectively sponsored the American Society of Plastic Surgeons to conduct a study.
For perspective, when adverse events are reported to the FDA, the manufacturer isn’t always known. Allergan often prints its name on implants, but others sometimes don’t. In many cases, a patient does not remember the name of the manufacturer.
7 On Your Side asked the director for Corporate Affairs at Allergan, Mark Marmur, for an on-camera interview. He declined but wanted to make sure that patients who had contacted 7 On Your Side had reported their experiences directly to the company, and he shared information about how to confidentially facilitate that process.
7 On Your Side submitted the following questions to Allergan:
- To the extent that it is possible, will Allergan track down, or ask surgeons to track down, every woman who received textured breast implants to inform them of the small but potential risk of BIA-ALCL?
- What is Allergan’s plan moving forward to help educate women and physicians about the issues regarding textured breast implants and ALCL? If an information campaign is in the works, please share the details.
- Is Allergan currently researching possible causation between textured breast implants and ALCL? When will results be released (whether to the FDA, ANSM, or the public at large)?
- Do you consider ALCL to be exclusive to the textured implants? If yes, what is it about texturing that appears to be problematic?
- How many cases of ALCL did you discover prior to adding it to your label, and when was it added?
Allergan’s Marmur replied to our questions with a statement, which is published in full below:
"Patient safety is always Allergan’s first priority. However rare, Allergan takes this disease seriously.
According to the FDA, BIA-ALCL has been reported in patients with textured breast implants from all manufacturers. Because of the limited number of confirmed BIA-ALCL case worldwide, the medical community has not been able to establish causality.
Allergan is actively working to help advance the knowledge of this disease, understand the association of BIA-ALCL and textured implants, and educate the community, including:
- Working closely with the FDA and global regulatory bodies to ensure that our products’ labeling documents include all information necessary for healthcare professionals and patients. This includes safety data, precautions, warnings, potential side effects. In addition, Allergan has added information on BIA-ALCL as a rare adverse event into the patient literature that accompanies every pack of implants in the US and internationally.
- Convening global medical experts and researchers to foster collaboration and advance the medical community’s knowledge and awareness of the disease. Allergan also has conducted surgeon education meetings and webcasts in the US and internationally since 2014.
- Working closely with FDA and other regulatory authorities to submit all reports of BIA-ALCL annually. Please see the FDA’s web site for additional information: http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm240000.htm#howtoreport;
- Supporting ongoing research to ensure physicians and patients have the latest scientific findings to appropriately diagnose and effectively treat the disease, ensuring women are appropriately informed, monitored, and managed if diagnosed with BIA-ALC.
- Partnering with ASPS, ASAPS and ISAPS to distribute BIA-ALCL educational materials and work with these societies on guidance for healthcare professionals regarding the appropriate management of patients.
Women with breast implants should be advised to perform regular breast self-examination, and consult their healthcare provider if they notice changes such as, swelling, pain, lumps, or asymmetry."
When 7 On Your Side asked again for direct answers to our questions, we received the following responses from DeSena:
1) To the extent that it is possible, will Allergan track down, or ask surgeons to track down, every woman who received textured breast implants to inform them of the small but potential risk of BIA-ALCL?
"Allergan continues to provide educational information regarding this disease to both physicians and patients, as well as working with the FDA and regulatory authorities to collect and assess safety reports to help inform the physician community, regulatory agencies and patients on the appropriate use of our implants. The surgeon and patient FDA-approved labeling for Allergan’s breast implants – as well as the labeling documents of all other breast implant manufacturers – discusses BIA-ALCL. Both the FDA and the leading plastic surgeon societies (ASPS and ASAPs) encourage routine breast care and support for patients who have received breast implants:
“Healthcare Providers: If you have patients with breast implants, you should continue to provide them routine care and support. ALCL is a very rare condition; when it occurs, it has been identified most frequently in patients undergoing implant revision operations for late onset, persistent seroma. Because it has generally only been identified in patients with late onset of symptoms such as pain, lumps, swelling, or asymmetry, prophylactic breast implant removal in patients without symptoms or other abnormality is not recommended.”
ASPS and ASAPS state: “Expert opinion is that asymptomatic women without breast changes do not require more than a routine follow-up."
Allergan supports the recommendations of the FDA and ASPS/ASAPS."
6) How many cases of ALCL did you discover prior to adding it to your label, and when was it added?
"Manufacturers have been reporting cases of BIA-ALCL as they have occurred, leading to FDA’s press release in 2011 informing the public of the potential association between breast implants and the development of ALCL. Then, US breast implant manufactures worked with FDA to develop language to be included in approved labeling documents, which were released in 2013. Allergan complies with applicable regulations relating to the reporting of BIA-ALCL to the FDA. The FDA has a webpage devoted to reports of ALCL it receives from breast implant manufacturers, which includes the date range of the reports, information regarding the type of implants, whether the surgery was for reconstruction or augmentation, etc.
THE FDA: “Many medical device reports … failed to include information about the texture.”
7 On Your Side also requested an on-camera interview with the FDA. Instead, press officer Stephanie Caccomo supplied written answers to all of our questions, paraphrased below:
FDA: First, let me direct you to information we have available on our website regarding ALCL which includes a link to our 2011 Safety Communication on the topic.
Q1. What is the relationship between ALCL and textured implants, since it appears this kind of implant is the one associated with the disease?
A1: Some scientists have suggested that a textured surface may be a risk factor for ALCL, but this has not been evaluated in a large, well-designed, epidemiologic study. Additionally, many of the ALCL medical device reports sent to the FDA in breast implant patients failed to include information about the texture of the shell. As of September 2015, of the reports received by the FDA, 50 percent of BIA-ALCL cases are with textured implants, four percent are with smooth implants, one percent have a history of both and 45 percent do not specify whether they were textured or smooth implants. As we continue to gather and analyze information, we will provide updated findings on our website as it becomes available.
Q2. At what point, in consideration of adverse event reporting, illnesses & death, does the FDA take some kind of action generally?
A2. The FDA typically issues Safety Communications related to reports of adverse events or other problems with medical devices when broad dissemination of the information is needed to reach affected patients and health professionals to ensure proper use of devices and the health and safety of patients. This may include posting recall information or issuing an FDA safety or other type of communication about a specific product or class of products. The FDA issued a Safety Communication regarding breast implants and ALCL in Jan. 2011 to communicate that while ALCL is rare, the FDA believes that women with breast implants may have a very small but increased risk of developing this disease in the scar capsule adjacent to the implant.
Q3.Why are textured breast implants designated as Class III medical devices?
A3: Class III devices are generally the highest risk devices and are therefore subject to the highest level of regulatory control. Class III devices must be approved by FDA before they are marketed. Breast implants were originally designated as Class II medical devices by the classification panels of the late 1970s. In 1988, in response to emerging safety concerns and recommendations from an expert advisory panel, the FDA re-classified breast implants to class III devices (requiring premarket approval). This class III designation applies to all breast implants, including saline-filled and silicone gel-filled implants with either a textured or smooth surface.
Q4: In 2011, the FDA was aware of 60 cases of ALCL in women with breast implants, and at the time, the FDA cautioned patients and health care providers about the risk. Now that the number of cases is at least double that number, including deaths. Additionally, the product sheets on the FDA website (for example, Allergan’s booklet Natrelle Saline-Filled Breast Implants Smooth & Biocell Texture) are from 2009 as well and don’t have the up to date information on BIA-ALCL. Should the information not be updated in 2017? Should the FDA not issue a new warning to patients & physicians?
A4: The FDA updated information available on its public ALCL website in 2016. This update included a summary of Medical Device Reports (MDRs), the medical literature, and FDA recommendations. The FDA continues to believe that the available information suggests that women with breast implants have a very low, but increased risk of developing ALCL. The agency strives to provide the public with evidence-based information that patients and health care providers can use to make informed decisions. Since 2011, FDA has approved revised breast implant labeling for all manufacturers to include information about ALCL. We will continue to provide updated findings as new information and analyses become available.
THE ANALYST: “We don’t know how common it is.”
7 On Your Side spoke with a leader in the field of women’s health, Diana Zuckerman, PhD, President of the National Center for Health Research. Zuckerman was our chief source for information about the risk of suicide after implants. Regarding BIA-ALCL, she wrote:
"It is not true that textured implants are the only ones associated with BIA-ALCL. This summary of a recent medical journal article clearly says that “most women with ALCL have at least one textured implant” but that doesn’t mean they all do.
Plastic surgeons have generally rejected any studies that report an association between disease and breast implants, and implant companies have paid researchers to publish studies that deny these associations, but there has been evidence of a link to various diseases for at least 15 years, including studies by NIH and FDA scientists:
- Silicone breast implants and autoimmune disease
- Ruptured breast implants and fibromyalgia
- Breast implants and cancer
- Study Links Breast Implants To Lung and Brain Cancers
Nobody really knows how common BIA-ALCL is. It is extremely unlikely that it is much more common in Australia than the US, and the US estimates are changing as doctors get better at diagnosing it and reporting it in medical journals. Unfortunately, like most complications, it is under-reported to the FDA. Most complications, even serious ones, are not reported to the FDA. In general, countries with National Health insurance have better medical records to calculate disease rates than we have in the U.S."
7 On Your Side is committed to following future developments regarding BIA-ALCL.
On a personal note, the plastic surgeon who alerted 7 On Your Side to his concerns about ALCL and implants passed away, in his sleep, this month. Dr. Scott Spear was a giant in the field of plastic surgery, having pioneered nipple-sparing mastectomies, having single-handedly brought silicone gel implants back on the market after a 14-year-long FDA ban, two noteworthy accomplishments among hundreds in a 125-page long resume. Dr. Spear told 7 On Your Side that when he served on the board at Allergan, he advise the company to do more to educate and warn women about the risks and he urged this journalist to stay on the story.