Banning Textured Breast Implants — Australia is the Latest Nation to Act — What Women Need to Know About the Danger

"I find it very hard to find a compelling reason to use textured implants," Dr. Alyssa Golas, plastic surgeon at NYU Langone Health, told SurvivorNet earlier this year when the American Food and Drug Administration held it’s hearings to better understand the pros and cons of textured breast implants.

The specific type of non-Hodgkins lymphoma that implants have been linked to is called Breast Implant-Associated Anaplastic Large Cell Lymphoma or BIA-ALCL, and it is completely distinct from breast cancer. It is rare, and symptoms include pain, redness and swelling around the implant and breast area.

It’s important that women with textured breast implants don’t become panicked– only a very small number of women with the implants have actually been diagnosed with implant-related cancer.

FDA Information about textured breast implants and cancer

The United States Food and Drug Administration has acknowledged that it has known of a potential relationship between breast implants and increased risk of ALCL since 2011, and they have said that they continued to monitor the number of implant related cancer cases.

RELATED: The FDA Says It Won't Ban Textured Breast Implants, But Will Keep Collecting Data

"After a thorough data analysis, we are reporting that, as of September 2018, the agency has received a total of 660 total medical device reports regarding BIA-ALCL cases since 2010," the FDA said in a report earlier this year. "Of the 660 MDRs, our in-depth analysis suggests that there are 457 unique cases of BIA-ALCL, including 9 patient deaths." "MDR" stands for Medical Device Reports, so there's been an increase in the number of reports the FDA has received about instances of the disease.

"We understand that the information presented shows an increase of 246 new MDRs since last year," said the FDA. "These types of increases in the MDRs are to be expected and may include past cases that were not previously reported to the FDA. The increased number of MDRs contributes to our evolving understanding of BIA-ALCL and represents a more thorough and comprehensive analysis."

"In addition, it is difficult to determine the total number of cases or estimate risk from the MDR reporting system due to potential under-reporting of events, possible duplicate reporting, and lack of data about the exact number of breast implants," the FDA warned.

France and Canada both banned this type of implant, due to it’s link to cancer.

Australian proposal to cancel and suspend the implants

The Therapeutic Goods Administration (TGA), Australia’s regulatory body for health related products, proposed regulatory action, which could include canceling, suspending or recalling the implants.

“Based on the laboratory and statistical review, the TGA has proposed regulatory action in relation to a number of textured implants only. Those proposed regulatory actions are either a proposal to cancel or a proposal to suspend. The TGA has also imposed new conditions on the inclusion of a number of other textured implants in the Register,” reads the proposal.

Nine different textured breast implant models were proposed for cancellation, all from the maker Allergan.

The products proposed for suspension included 16 implant and tissue expander models made by drug companies including Adirel Consolidated, Emagin, Emergo Asia Pacific, Euro Implants, JT Medical, and Johnson and Johnson Medical.

The proposal also included a section about products for which patients should be provided informational leaflets before the implants. The six implants on that list are made by Allergan, Emagin, and JT Medical.

The Australian health minister Greg Hunt said that the government supported the proposal, which came after the TGA received seventy six reports of ALCL. The estimated risk of breast implant related ALCL is between 1 in 1,000 and 1 in 10,000.

Pros and Cons Of Textured Implants

For a lot of doctors, the risk of textured implants is just not worth the possible reward.

Yet, there are reasons why some women want textured breast implants. Some doctors used to think textured implants were preferable, because they reduced another health risk that other types of implants can cause. "It used to be thought that textured implants reduced the risk of capsular contracture, which is the body making scar tissue around the implant, which can be uncomfortable or it can change the appearance and deform the implant, or both,” said Dr. Golas said.

As it turns out, capsular contracture may not be as closely tied to textured implants as doctors once thought. "But as we learn more about capsular contracture, it seems to be more related to very low grade infection, as opposed to the texture of the implants."

Rather, there are factors that may contribute more directly to increased risk of capsular contracture. "There's some data to suggest that certain techniques that the surgeon uses while putting the implant in can reduce the risk of capsular contracture. It's not a totally well understood phenomenon, but that's what we think now," says Dr. Golas. "Also if women get radiation for cancer, then they are also at higher risk for capsular contracture."

Aesthetics of Textured vs. Smooth Implants

Aesthetic reasons can also play a role in the decision between textured and smooth implants. "Sometimes people want tear drip shaped (called "anatomic" implants) instead of round implants. And because the narrow part has to be at the top and the round part at the bottom, the texture prevents them from flipping around inside the body. If they're not textured, they can move and flip around inside the body. So if it's a round implant and it flips around, it's no big deal."

"Some people like that the implants stay exactly where you put them, and so some surgeons like that feature, and think it's important to use them. I don't," continues Dr. Golas. "I don't see breasts as fixed objects. I think they're more natural when they move around."

Dr. Golas also noted that smooth implants don't increase the risk of cancer. "There hasn't been any patient found with all with only smooth implants. There have been some patients who have had textured implants in the past, and then had them removed and then had smooth implants and developed ALCL, but there is no instance of a patient with only smooth implants. So it's possible that exposure to textured implants at some point in your life could put you at risk."

When asked what makes textured implants increase the risk of cancer, Dr. Golas says it is still unclear. "There are some studies about it now maybe something to do with chronic inflammation. But there is a lot of research happening right now to try to answer that question," says Dr. Golas.

 

Breast Cancer Risk Tied To Allergan

Previously, the issues the FDA highlighted were tied specifically to the Allergan brand. At the end of 2018, Allergan, a leading global biopharmaceutical company, suspended its sales of textured breast implants and tissue expanders, and withdrew its supply from all European markets.

"The withdrawal decision follows a compulsory recall request from Agence Nationale de Sécurité du Médicament (ANSM), the French regulatory authority. The suspension of sales stems from the expiration of the company's CE Mark for these products," Allergan announced at the time.

 

 

 

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