Breast Implant Alert : Again

"We're certainly aware of the increased risk for women who have got textured implants."
"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."
Dr. Frances Wright, surgeon, surgical oncology program, Cancer Care Ontario

On March 5 surgeons and breast cancer reconstruction specialists received a notice from Cancer Care Ontario warning that textured implants -- coated with a light sandpaper-type exterior -- have been linked to anaplastic large-cell lymphoma (BIA-ALCL) in the case of breast implants. "Recent media publications regarding these implants", referring to a study from 2017 was cited by the agency now advising that women who have worn the implants for over a year, and who have been assailed with swelling or fluid build-up are candidates for tests for BIA-ALCL.

Those who have the implants and scar capsules removed can make a full recovery, but if left untreated the cancer can spread. Photograph: The Guardian design team for the Guardian

"This is the biggest controversy in plastic surgery."
"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."
Dr. Frank Lista, plastic surgeon, Toronto

"[Patient safety is the company's] highest priority [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."
"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."
Allergan pharmaceutical company

"[By contacting the estimated 15,000 patients (in Quebec) 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."
Quebec Ministry of Health

"[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."
Manitoba Ministry of Health

BIA-ALCL is a kind of non-Hodgkin's lymphoma. (Photo: BranislavP, Getty Images/iStockphoto)

Across Canada provincial health ministries and their associated cancer agencies are actively urging vigilance while awaiting clear guidelines from Health Canada, according to a survey of provinces responding to the latest data linking these textured breast implants with a very specific type of breast cancer. Health Canada has assured that it is studying the issue and working with international partners in gathering information to "inform any regulatory actions", with the safety review's completion anticipated in spring.

News organizations globally have published a joint investigation respecting medical devices, along with the International Consortium of Investigative Journalists. An expose of lax oversight of medical devices in Canada was reported pointing out that Biocell implants by Allergan have been blacklisted by a number of Canadian plastic surgeons whose attention has turned to high rates of health issues including BIA-ALCL linked with the textured breast implants.

There have been calls for the devices' removal from the market entirely. The Allergan Biocell textured implants have been implicated in all cases reported to Cancer Care Ontario. Even so, the implants remain on the market, apart from the fact that they have been implanted in millions of women continent-wide. It has been revealed that many studies available in the medical literature were written by industry-paid researchers.

Terri McGregor underwent eight rounds of chemotherapy after being diagnosed with a rare form of cancer known as breast implant-associated anaplastic large cell lymphoma, or BIA-ALCL. (Terri McGregor)

As a result of the growing number of stories relating BIA-ALCL with the textured implants Health Canada announced its intention to institute sweeping reforms in its regulation of the medical device industry, announcing its intention to update its safety review of BIA-ALCL post 22 confirmed cases and an additional 22 suspected cases where previously the agency had considered no inquiry to be required.

As far as the manufacturer, Allergan is concerned, the rise in Canadian cases of BIA-ALCL may be the result of an increased awareness among doctors; that there "has been no new clinical evidence" with respect to the safety of textured breast implants. A month following the initial investigation in November and its publication, Brazil, which represents the world's second-largest beast implant market, suspended Allergan textured implants.

The U.S. Food and Drug Administration in February warned American doctors about the association between the cancer and the implants and the agency plans to hold hearings on breast implant safety in late March.

The physical properties of breast implants are thought to influence tissue morphology in the patients who receive them.