More provinces warning cancer risk of textured breast implants
|Toronto Star 15 Mar 2019 at 13:29|
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 (BIA-ALCL).
Textured breast implants, seen here after they were removed from a B.C. woman who developed a rare form of cancer, implant-associated anaplastic large cell lymphoma (BIA-ALCL). Provinces across Canada have begun warning doctors and patients about the implants. (Jesse Winter / Star Metro file photo)
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 BIA-ALCL.
“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.
Biocell breast implants at centre of ‘biggest controversy in plastic surgery’
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 international regulators in their reviews of the rare cancer associated with breast implants.
“Breast implant patients should consult their health care professional if they are experiencing unusual changes to their breasts, including breast pain, sudden swelling, or a lump,” an Allergan spokesperson said.
Allergan said the spike in Canadian cases of BIA-ALCL are 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 in the spring of this year, 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 textured implants and BIA-ALCL. The agency is also holding hearings on breast implant safety later this month.
Also last month, France’s health regulator called for a ban of textured breast implants. Allergan had suspended sales of its textured implants in Europe in late December after the devices’ safety certification, known as a CE mark, was not renewed by a French regulatory authority. The company said at the time that it stands behind the safety of its products.
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 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.”
“The Nova Scotia Health Authority will followup with patients who are identified as having this device, if any,” the spokesperson said.
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, “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 Vancouver-based plastic surgeon in its discussion on the topic.
In Ontario, Cancer Care Ontario said in a statement to the Star last week that it is now working with the Ministry of Health and Long-Term Care to “co-ordinate next steps to ensure patients are receiving the best evidence-informed care” while it awaits updates from Health Canada.
Health officials from Prince Edward Island did not answer questions about its response to the emerging safety concerns.