Biocell breast implants at the centre of ‘biggest controversy in plastic surgery’
More plastic surgeons are sounding alarm on health problems but device makers defend their safety
Katherine Smylie gradually lost her health, her career and mobility and no one could explain why.
Her Edmonton doctors tested her. They concluded she was fine.
That diagnosis was at stark odds with what the 47-year-old was experiencing: After a double mastectomy led to breast augmentation surgery in 2012, Smylie’s symptoms began piling up — from se- vere pain to hair loss, poor sleep, dry eyes, memory loss, irritable bowel syndrome, low libido, brain fog, exhaustion, migraines and an inability to complete basic work or household tasks.
By 2016, she was too sick to continue working.
“I couldn’t figure out why this was happening,” she said. “I never thought in a million years that (breast implants) were the reason why I was getting sick.”
Smylie’s textured Biocell implants — made by industry giant Allergan — have come under scrutiny among a growing number of plastic surgeons who are documenting high incidents of health problems. Some are blacklisting the oncepopular devices and calling for their removal from the market, a Toronto Star/ CBC/Radio-Canada investigation, in partnership with the International Consortium of Investigative Journalists, has found.
Device makers defend the safety of textured, rough-surface implants, in part, through industry funded studies au- thored by researchers who are paid consultants. This has led to conflict of interest allegations that medical associations and physicians acknowledge have merit.
Health Canada and the U.S. Food and Drug Administration acknowledge a connection between textured implants and lymphoma — a phenomenon that has not emerged with smooth-surfaced breast implants.
IMPLANTS from A1
Biocell implants remain on the market and inside millions of women across the continent.
Textured implants, designed to keep the devices from moving inside the body, were first embraced by plastic surgeons three decades ago and quickly grabbed dominant marketshare through the 1990s and early 2000s. They have since declined in popularity — down to about 12 per cent of the market today in North America — as evidence mounts of complications, movement post-implantation and connections to a rare form of breast-implant-related cancer called BIA-ALCL. But the North American market is an anomaly. Worldwide, textured implants remain popular.
There are 25 confirmed cases of BIA-ALCL in Canada — according to yet-to-be published data compiled by two prominent plastic surgeons — of which 23 are linked to Biocell implants. Last week, French authorities announced a review of textured implants, noting the country’s 53 confirmed cases of BIA-ALCL had an “over-representation of textured breast implants.” Out of 272 BIAALCL cases documented by the U.S. Food and Drug Administration (FDA), 242 were found to have textured surfaces — 89 per cent.
Allergan declined interview requests for this story and issued a statement that did not specifically address its Biocell implants. Patient safety is Allergan’s “highest priority,” the company said in a statement, and the safety of its breast implants is supported by “extensive pre-clinical device testing, more than a decade of worldwide clinical use, as well as a large number of peer-reviewed and published studies.”
Based on information “provided by manufacturers and a variety of other sources,” health authorities around the world have monitored the safety of implants and “are not recommending any change in implant availability, current practice, post-implant care and checkups,” the statement company’s reads.
“There’s a real problem here,” said Dr. Donald Mackay, a plastic surgeon and associate chair of the surgery department at PennStat e Hershey who stopped using textured implants, as did all faculty at the teaching hospital, in 2016.
“I’m embarrassed that we as plastic surgeons haven’t managed to sort this out. It’s been one of the most frustrating things for me that I can’t convince our leaders in industry that we have a problem here. It’s staring us in the face.”
The latest warning about Biocell is a Vancouver study that found more than 85 per cent of the Biocell breast implants analyzed had “failed” — defined by a range of outcomes, including hardening, pain, rupture and other “abnormal findings.” That failure rate was well beyond that of any other type of implant.
“I think we’re close to the point where it’s probably a device that should be removed from the market,” said Dr. Nicholas Carr, a Vancouver plastic surgeon and senior author of the study which analyzed 539 implants that were removed by him from his patients. “There have been voices arguing for that.”
The study found Biocell had the shortest lifespan (from implantation to explantation) and were more frequently associated with pain. Just under half of the Biocell implants — 42 per cent — developed double capsules, a formation of two distinct layers of tissue around the implant separated by fluid that “was not observed with any other implant type.”
In an interview, Carr said the Biocell textured implants “stood out as having…an array of abnormal inflammatory type findings we’d never seen before.”
In a statement, Health Canada said it reviews scientific literature, including the Vancouver study, noting that “these studies are based on small population samples over a large period of time” and that “researchers and surgeons have recognized the confusing effectiveness evidence with regard to textured breast implants and further investigations are planned by clinical researchers.”
In 2011, Alberta plastic surgeon Dr. Elizabeth Hall-Findlay was one of the first to raise concerns about Biocell implants in a study that found double capsules were only seen with the Biocell textured surface implants.
She stopped using the implants a decade ago.
“I now look back at all cases with textured implants and can say my complication rate with those has been way higher,” said Hall-Findlay, who had a patient with ALCL in 2012. “Why are we ignoring the elephant in the room?”
Toronto-raised-and-trained plastic surgeon Dr. Eric Swanson proposed the immediate abandonment of textured implants at a Canadian plastic surgery meeting in June 2016. He said there were physicians who supported his statement, but little in the way of change or public awareness has followed.
“I don’t think the word has really gotten out on this,” said Swanson, who practises in Kansas City.
Here’s his theory on why that is: “There is a heavy commercial influence keeping them in the marketplace.”
That commercial influence includes company-funded research that attributes adverse events to surgeons not being adequately sterile when inserting the implants rather than faulty implants.
“Most of the (researchers in the U.S.) are funded by industry,” he said. “These are profitable implants that have been put inside millions of women. Ironically, none of the recommendations include simply not using textured implants. You can look for a cause if you like, but in the meantime, you should take these off the market because they’re causing risks to women.”
Swanson used textured implants in the 1990s but he grew to dislike them because they failed to reduce capsular contracture — the formation of scar tissue around implants that can become hard and painful — as promised. He stopped using them in 2000, switching to smooth-surfaced implants.
“I suspected for a few years now that this would become a crisis,” said Swanson. “And I think it’s on the verge of that happening. I think there are surgeons who will be concerned about their liability and I think they should be.”
Toronto plastic surgeon Dr. Frank Lista stopped using textured implants in 2013 after coauthoring a study based on the outcomes of 440 patients with an Allergan textured implant. The study detailed a 16.6-percent complication rate and 10.7 per cent of patients requiring another operation.
“This is the biggest controversy in plastic surgery,” he said in an interview. “There’s a lot of money involved. The companies have a lot of money invested in the development and propagation of these implants. And there are surgeons who have staked their reputations on the advantages of these implants. Those guys are really concerned about that, not from a purely financial viewpoint, but from the reality that what you’ve been doing in the best interests of your patients, and you’ve been talking about and promoting, maybe isn’t in the best interests of patients anymore. That’s a huge course adjustment in your life. That’s a cold awakening.”
There is plenty of published academic literature defending Biocell implants. The authors of those papers frequently identify themselves as paid company consultants, stockholders or even employees.
A 2014 study summarized the recommendations of five plastic surgeons who have performed numerous breast augmentations with Biocell implants and concludes that the benefits, including low rates of “rippling” — ridges or wrinkles in an implant that are visible through the skin — far outweigh the “small risks.”
The study, published in the Aesthetic Surgery Journal, discloses Allergan as having provided financial support for “manuscript, writing and editorial assistance” as well as for the authors’ attendance at a 2013 meeting in Stockholm, Sweden. Four of the five authors identified themselves as consultants and/or speakers for Allergan. One also listed himself as a shareholder and royalty recipient.
Another study published last year that found that despite complications linked to a specific model of Allergan textured implants, the devices remain a safe option. The lead author is a paid consultant and speaker for Allergan and a co-author is an Allergan employee and stockholder.
An Allergan spokesperson said the company adheres to “all legal and regulatory requirements for training physicians on the safe use of our products, and transparency in our interactions with physicians around clinical research.”
According to public registers, more than half of American plastic surgeons have declared financial relationships with industry.
For the first time, the American Association of Plastic Surgeons will require prospective presenters at its next annual conference to disclose the money they have received from industry over the past three years. “We have no idea what its impact will be, but those of us in leadership feel very good about it and providing leadership for our specialty in (conflict-of-interest) disclosure,” said Dr. Niicholas Vedder, the association’s president.
In its statement, Health Canada said promotional activities by pharmaceutical and medical device industries can help create awareness of products but can also “lead to certain purchasing practices,” “unduly influence prescribing behaviours and lead to inappropriate prescribing.”
Some plastic surgeons have been warning their patients about textured implants. In 2016, a Texas plastic surgeon who had stopped using Biocell warned of links between implants and lymphoma, writing “it seems that the lymphoma occurs in textured Biocell implants,” calling models made by Allergan, “the most likely culprit.”
Allergan will not say how many Biocell devices have been implanted in Canada. Plastic surgeons interviewed say that as much as 70 per cent of the market could have been textured during the peak of its popularity.
“We’re talking well in excess of thousands (implanted in Canada),” Carr said in an interview. “It was certainly a lot.”
A recent Penn State survey of 824 North American plastic surgeons found 40 per cent still using textured implants.
Two patients whose implants were analyzed in Carr’s study agreed to an interview on condition that they not be named because their family members and colleagues are not aware of their implants.
One, a Vancouver woman in her 30s, got the implants eight years ago. Seven months ago, she noticed severe swelling in the right breast.
“The first thing they told me was that it was cancer. It was a lot of emotion for a girl who is five months pregnant and has dealt with cancer with my dad. I couldn’t sleep for weeks.”
She had surgery within five days. It turned out that a pocket of fluid had formed around the implant — not cancer. Because she is pregnant, she will wait until after giving birth to have the second implant removed.
The other patient is a Vancouver woman in her 40s who got textured Allergan implants in 2012. Everything was fine for years. But a test earlier this year showed that although she had tested negative for cancer, her lymph node was covered in silicone from a ruptured implant.
“It was shocking. When my pathologist read this out loud, he said, ‘Wow, I’ve never seen this before.’ He said, ‘Your body is having a reaction to silicone.’…If I had not gone for the mammogram I would never have known.”
Biocell implants remain beneath the public radar because there are few mechanisms in Canada to inform the public of any concerns, say experts.
“You’d expect some mechanism for public reporting,” says Carr. “I don’t think that system is intact. The feedback loop isn’t there. If you go to Health Canada or the FDA and ask a simple question like how many Biocell implants have been removed…I don’t think you could find that data, even though industry may have it.”
Absent clear public reporting of adverse events, it was anecdotal — but conspicuous – problems with Biocell implants that led Carr to analyze his patient records.
Even physicians, he said, have a hard time detecting the broader trends and health issues with devices until they perform enough procedures to spot patterns.
“The flow of information from adverse event reporting, industry monitoring, industry reporting to government and back to physicians and consumers is currently not reliable,” said Carr. “It’s not a terribly good system."
In March, Katherine Smylie’s research led her to a clear decision: “I wanted them out.” She had trouble finding a physician who would do it.
“They all told me that I was crazy, that there was no such thing as breast implant illness,” she said. “I was told by numerous doctors, neurologist, family physician, plastic surgeon, that I was out of my mind.”
She eventually found a specialist in Florida who performed the surgery last month.
Already, most of her symptoms have vanished or eased, she said.
“Such a big difference. (It is a) sigh of relief.”
“They all told me that I was crazy, that there was no such thing as breast implant illness. I was told by numerous doctors, neurologist, family physician, plastic surgeon, that I was out of my mind.” KATHERINE SMYLIE “I’m embarrassed that we as plastic surgeons haven’t managed to sort this out.” DR. DONALD MACKAY PLASTIC SURGEON AND ASSOCIATE CHAIR OF THE SURGERY DEPARTMENT AT PENNSTATE HERSHEY