Warnings issued over cancer risk tied to breast implants
Ontario among provinces telling doctors, patients to be vigilant as Health Canada conducts review
Provinces across Canada — including Ontario — have begun warning plastic surgeons and their patients about textured breast implants and their link to a rare form of cancer.
In a March 5 notice to surgeons and breast cancer reconstruction specialists, Cancer Care Ontario warned that textured implants — devices coated with a light sandpaper-like exterior — have been tied to breast implant-associated anaplastic large-cell lymphoma (BIAALCL).
Citing a 2017 study and “recent media publications regarding these implants,” the agency advises that women who have had the implants for more than a year and who experience swelling or fluid buildup should be tested for BIAALCL.
“We’re certainly aware of the increased risk for women who have got textured implants,” said Dr. Frances Wright, a Toronto surgeon and a lead with Cancer Care Ontario’s surgical oncology program.
“We have been in contact with our plastic surgery content experts to determine what our best approach is to provide guidance to clinicians who have treated patients with textured implants.”
Spokespersons for the health departments in Quebec and Nova Scotia say women with textured implants will be contacted and other provinces have urged physicians to monitor and inform patients.
These actions are part of a global shift in how governments view these popular breast implants after news organizations around the globe, including the Star, published a joint investigation into medical devices in November with the International Consortium of Investigative Journalists.
A Toronto Star/CBC/RadioCanada series exposing lax oversight of medical devices in this country reported for the first time that Biocell implants by manufacturer Allergan have been quietly blacklisted by a growing number of Canadian plastic surgeons who have noticed high rates of health issues, including BIA-ALCL. Some called for the devices to be removed from the market.
All cases reported in Canada have been associated with Allergan Biocell textured implants, the Cancer Care Ontario warning reads. Biocell implants remain on the market and inside millions of women across the continent.
“This is the biggest controversy in plastic surgery,” Dr. Frank Lista, a prominent Toronto plastic surgeon, told the Star in the fall.
“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.”
Allergan said in a statement that patient safety is the company’s “highest priority” and the safety of its breast implants is supported by “extensive preclinical device testing, more than a decade of worldwide clinical use, as well as a large number of peer-reviewed and published studies.”
The company said it supports Health Canada and other in- ternational regulators in their reviews of the rare cancer associated with breast implants.
“Breast implant patients should consult their healthcare professional if they are experiencing unusual changes to their breasts, including breast pain, sudden swelling, or a lump,” an Allergan spokesperson said.
A Toronto Star review of the medical literature found many of those studies were authored by researchers who are paid consultants for the industry — an issue that has triggered conflict-of-interest allegations from medical associations and physicians.
Following the Toronto Star/ CBC/Radio-Canada investigation, Health Canada announced sweeping reforms to its regulation of the medical device industry. And last month, the agency announced it will be updating its safety review of BIA-ALCL after receiving information of 22 confirmed cases and another 22 suspected cases. Previously it had said no further inquiry was required.
Allergan said the spike in Canadian cases of BIA-ALCL is believed to be caused by an increased awareness among doctors, and there “has been no new clinical evidence” concerning the safety of textured breast implants.
In a statement last week, Health Canada said it is now working with international partners to gather information that will “inform any regulatory actions.” The safety review is expected to be completed this spring, it says.
Canadian women with textured implants who spoke with the Star received a letter from a Health Canada director general in the past week saying the agency wishes to hold a breast implant safety meeting with patient advocates later this month. Health Canada confirmed Tuesday it is planning to meet with “several women who wrote to the department about breast implants” as part of its review.
In December, a month after the investigation was published, Brazil — the world’s second largest breast implant market — suspended Allergan textured implants.
Last month, the U.S. Food and Drug Administration warned American doctors about the association between the implants and BIA-ALCL. The agency is also holding hearings on breast implant safety later this month.
Provincial health ministries and cancer agencies across Canada are also urging vigilance as they await clear guidance from Health Canada, a survey of provinces has found.
In early March, the Quebec Ministry of Health announced it has asked the province’s hospitals and clinics to contact all patients who received textured breast implants since 1995 and warn them of a potential risk of BIA-ALCL. A spokesperson said by contacting the estimated 15,000 patients, the minister “is taking an additional step to ensure that women with textured implants are aware of the situation, know if they are affected by it, and know the symptoms to watch for.”
In Nova Scotia, a spokesperson said the province’s health authority is gathering details on how many women received textured implants, adding it’s believed “use has been limited.”
In New Brunswick, the Department of Health is reviewing Health Canada’s safety alert and communicating with the regional health agencies “where these surgeries are performed in relation to messaging for women with textured breast implants,” a spokesperson said.
A spokesperson said Newfoundland and Labrador’s Department of Health would expect regional health authorities to use health records to identify any potentially affected patients and “inform their respective physicians, so the physicians can then in turn notify their patients.”
A statement from Alberta Health says: “We encourage anyone with concerns or symptoms to call their family physician or plastic surgeon.” Saskatchewan’s Ministry of Health said in a statement that plastic surgeons in the province are “working directly with patients so that they can make informed choices about their options and risks.”
In Manitoba, the government says plastic surgeons “are aware of this issue and have received information on what to look for and how to care for these patients. They share that information with their patients to provide details of any potential risks associated with the specific breast implant.”
B.C. Cancer said it is aware of an “increase in reports of Canadian cases” of BIA-ALCL and has included a Vancouverbased plastic surgeon in its discussion on the topic.
Cancer Care Ontario said in a statement to the Star last week that it is now working with the province’s Ministry of Health and Long-Term Care to “co-ordinate next steps to ensure patients are receiving the best evidence-informed care.”
Health officials from Prince Edward Island did not answer questions about their response to the safety concerns.
All reported Canadian cases are associated with Allergan Biocell textured implants