More Implant Dangers

More provinces warning cancer risk of textured breast implants

By Robert CribbInvestigative Reporter
Jesse McLeanInvestigative Reporter

Fri., March 15, 2019 Toronto Star

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).

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.

A Toronto Star/CBC/Radio-Canada 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 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.

A Toronto Star review of the medical literature found many of those studies 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 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 early March, the Quebec ministry of health announced that 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 directly, 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.”

“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.

Robert Cribb is a Toronto-based investigative reporter. Reach him via email: Investigative reporter Jesse McLean can be reached at 416-869-4147.

Read more:

Breast implant recipients say doctors gloss over risks

Biocell breast implants at centre of ‘biggest controversy in plastic surgery’

*   *   *   *

Reports of breast implant illnesses prompt U.S. federal review

By Denise GradyThe New York Times
Roni Caryn Rabin

Tues., March 19, 2019

Reports from thousands of women that breast implants are causing problems like debilitating joint pain and fatigue, claims long dismissed by the medical profession, are receiving new attention from the Food and Drug Administration and researchers.

This may be a long-awaited moment of validation for tens of thousands of women who have been brushed off as neurotic, looking to cash in on lawsuits or just victims of chance who coincidentally became ill while having implants.

The FDA has begun to re-examine questions about implant safety after receiving reports from thousands of women that breast implants are causing problems like debilitating joint pain and fatigue.

The FDA has begun to re-examine questions about implant safety after receiving reports from thousands of women that breast implants are causing problems like debilitating joint pain and fatigue.  (MAXPPP / TNS)

The FDA has begun to re-examine questions about implant safety that have long been disputed by doctors and implant manufacturers, and that most consumers thought had been resolved a decade or so ago.

Millions of women have implants, which are silicone sacs filled with either salt water or silicone gel, used to enlarge the breasts cosmetically or to rebuild them after a mastectomy for breast cancer.

On Tuesday, the agency warned two makers of breast implants that they had failed to conduct adequate long-term studies of the devices’ effects on women’s health. Those studies were mandated as a condition of approving the implants, and the agency cautioned that the devices could be taken off the market if the research wasn’t properly carried out.

The agency also issued a statement Friday that applied to a broad array of medical devices, acknowledging that implanted devices may make some people sick. “A growing body of evidence suggests that a small number of patients may have biological responses to certain types of materials in implantable or insertable devices,” the agency said. Those effects can include “inflammatory reactions and tissue changes causing pain and other symptoms that may interfere with their quality of life.”

Read more:

More provinces warning cancer risk of textured breast implants

‘My entire body was shutting down.’ Breast implant recipients say doctors gloss over risks

Breast-implant-related complications, including cancer, kept secret thanks to broken reporting system

The FDA said it was gathering information to fill information gaps in the science “to further our understanding of medical device materials and improve the safety of devices for patients.” Silicone, used in implants, is one of the materials under scrutiny.

And next week, the agency will hold a two-day meeting about breast implants, hearing from researchers, patient advocacy groups and manufacturers.

One problem to be discussed is an uncommon cancer of the immune system called anaplastic large cell lymphoma, which has been detected so far in 457 women with breast implants, according to the FDA. Removing the implants usually eliminates the disease, but some women have also needed chemotherapy, and 17 deaths from the cancer have been reported worldwide.

Nearly all the lymphoma cases have occurred in women who had implants with a textured surface, rather than a smooth one. Textured implants made by Allergan, a major manufacturer, were taken off the market in Europe in December. Smooth implants are used more often than textured ones in the United States.

The new warnings are of potential concern to millions of women with implants. About 400,000 women in the United States get breast implants every year, including 300,000 for cosmetic reasons and 100,000 for reconstruction after mastectomies performed to treat or prevent breast cancer. Worldwide, about 10 million women have breast implants.

The FDA’s new focus on implants is a testament to the power of patient activism in the age of social media, as sick women frustrated by their doctors’ lack of answers sought information online, found other patients with similar complaints and banded together to demand regulatory action. One Facebook group, has nearly 70,000 members, according to its founder, Nicole Daruda, a Vancouver Island, British Columbia, woman who felt well when she got implants in 2005 for reconstruction after cancer surgery, but soon became so ill she had to stop working.

Daruda had them removed in 2013, and said most, but not all, of her symptoms have lessened.

Another patient activist, Jamee Cook, now 41, had implant surgery for cosmetic reasons when she was 21. Over the next few years she developed so many health problems, including fatigue, memory lapses, migraines and numbness in her hands, that she had to quit her job as a paramedic.

After having the implants removed in 2015, she said, her health has improved. Though she still has some bad days, Cook said, “It’s been like a 180.”

Silicone-filled breast implants were first marketed in the United States in the 1960s. Over the next few decades, reports of illness emerged. In 1992, silicone implants were banned, except for reconstruction after mastectomy or to replace a previous implant, and then only in clinical trials.

A flood of lawsuits followed.

Studies conducted afterward generally found no link to connective tissue disease, but a few did suggest a connection. In 1999, the Institute of Medicine, then part of the National Academy of Sciences, concluded that overall, there was no evidence that breast implants caused connective tissue disease, cancer, immune disorders or other ailments.

In 2006, silicone implants came back on the market. But manufacturers were required to follow large numbers of women for seven to 10 years, as a condition for FDA approval. Deficiencies in the studies have now prompted the agency to send warning letters to two of the four companies approved to market breast implants in the United States.

One warning letter, sent to manufacturer Sientra, of Santa Barbara, California, on Tuesday, said the company had not kept enough patients in its study of an implant approved in 2012, and warned that if the follow-up monitoring did not improve, the agency could withdraw approval of the implant, effectively taking it off the market.

Rosalyn d’Incelli, vice president of clinical and medical affairs for Sientra, said the company tries to retain patients in follow-up studies by compensating them, contacting them several times a year through email, phone calls, letters and postcards, and transferring them to doctors in more convenient locations. But she said that patients’ work obligations, child care, lack of transportation and other issues often present obstacles.

“We are aware of and take this matter seriously,” D’Incelli said, adding that the company will respond to the FDA about corrective measures it plans to take. “Patient safety, ensuring long-term safety and effectiveness of our devices and complying with FDA’s requirements are our highest priority.”

Its stock price dropped a little more than 4 per cent on the FDA news.

In September, the Securities and Exchange Commission accused its former chief executive, Hani Zeini, of concealing damaging information about the manufacturer of its implants before closing a $60 million (U.S.) stock offering in 2015. The Brazilian manufacturer had had a certificate of compliance required for selling in the European Union suspended. Sientra said its issue with the SEC had been resolved.

The other letter went to Mentor Worldwide, owned by Johnson & Johnson and based in Irvine, California. The FDA said the company had not enrolled enough patients in a study of its MemoryShape implant, approved in 2013, and also threatened to rescind approval for the product. Withdrawing approval for a medical device is time-consuming and rarely occurs.

Mindy Tinsley, a spokeswoman for Mentor, said the company was disappointed by the FDA’s decision to issue a warning letter “despite our good faith efforts to address post-approval study requirements.” She said Mentor notified the FDA last year that it would fall short of study enrollment targets because of changes in consumer preferences, but did not hear back. Johnson & Johnson’s stock remained unaffected Tuesday.

According to the FDA, the other two manufacturers whose breast implants are approved in the United States are Allergan and Ideal Implant, which did not receive warning letters Tuesday. But their implants have also drawn some illness-related complaints from women.

Plastic surgeons and implant manufacturers often say breast implants are the most intensely studied of all medical devices. But critics and patient advocates say most studies done to date are flawed.

“When plastic surgeons tell women that ‘this is the most studied medical device in the world,’ women assume that means they are proven safe,” said Diana Zuckerman, president of the National Center for Health Research in Washington, D.C., who has been advising advocates for patients with implant-related illness. But, “we still don’t know what percentage of women become seriously ill from their breast implants. We still don’t know why some women get sick right away, some get sick years later and some never get sick.”

Plastic surgeons at M.D. Anderson Cancer Center in Houston who looked at the long term outcomes of 99,993 women with silicone implants reported finding they had six, seven and eight times the normal population rates of rheumatoid arthritis, scleroderma (a connective tissue disease) and Sjogren syndrome (an autoimmune disorder), all of which are relatively rare diseases.

An author of the study, Dr. Mark Clemens, cautioned that it did not prove cause and effect, and said in an interview: “The overarching message is that breast implants are reasonably safe and have high patient satisfaction, but also have complications that patients should be made aware of.”

Critics said the study, published in Annals of Surgery in September, did not adjust for underlying differences between women with and without implants, and that the data, drawn from the FDA’s own database, was flawed because of high dropout rates.

“All the evidence we have to date is that implants are safe,” said Dr. Amy S. Colwell, a plastic surgeon at Massachusetts General Hospital in Boston who wrote an editorial criticizing the study, and who is a consultant for Allergan, an implant manufacturer.

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