Tag Archives: breast implant

Allergan is trying to track down women with breast implants it recalled nearly a year ago

Maria Aspan, Fortune: June 03, 2020


More than 10 months after recalling some of its breast implants, Allergan is making a new effort to find tens of thousands of women who still have the dangerous devices.

The pharmaceutical company, now owned by AbbViesaid this week that it will launch a digital and social media ad campaign to alert patients about the July 2019 recall of its textured Biocell implants. Those implants have been linked in academic studies to a sometimes-fatal cancer known as BIA-ALCL, for “breast implant–associated anaplastic large cell lymphoma.” More than 33 women have now died from BIA-ALCL.

Allergan’s announcement comes two weeks after Fortune published an investigation into the persistent problems with breast implants and the health risks, including BIA-ALCL, they have created for millions of women worldwide. These risks have been amplified by decades of inadequate study and problems that were hidden by breast implant manufacturers, as well as the generally poor tracking of medical devices, our investigation found.

Many women affected by Allergan’s Biocell recall told Fortune that they found out about it through social media or news reports, rather than directly from the company or the U.S. Food and Drug Administration, which requested the recall.

On Monday, Allergan acknowledged that it does not have device-tracking information for some 52,000 Biocell breast implants. Despite “robust efforts” to reach patients since last July, “the company is still seeking to directly contact all U.S. Biocell patients that have not yet been notified,” Allergan said in a press release.

“We are continuing to make every effort to make sure that each and every patient is made aware of the Biocell recall, and knows their implant type and implant history,” John Maltman, Allergan’s vice president of medical affairs, said in the release.

A company spokesperson did not respond to a request for more specifics about when the ad campaign would launch, or what exactly it would entail. And longtime critics of breast implant safety greeted Allergan’s announced plans with skepticism.

“I don’t know how visible it’s going to be,” says Diana Zuckerman, president of the National Center for Health Research. “Will the kind of money and effort be put into this in a way that’s comparable to ad campaigns when they’re selling something?

The new ad campaign appears to be at the behest of the FDA, which “asked Allergan to develop a strategy to contact patients who may not have heard about the recall,” an agency spokesperson told Fortune by email on Tuesday, adding that the FDA “is working with Allergan to amplify the message and outreach related to its July 2019 voluntary recall of certain breast implants.”

This is the latest of several actions the FDA has taken on breast implant safety in the wake of Fortune’s investigation. Last month, after speaking with Fortune, the FDA sent a warning letter to Allergan over its longtime failure to comply with regulatory requirements for selling its implants. At the same time, the agency also sent a letter to a smaller manufacturer warning about manufacturing and quality-control issues.

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Read the full article here.

Women Should Be Warned of Breast Implant Hazards, F.D.A. Says

Roni Caryn Rabin, NY Times: October 23, 2019


Women considering surgery to receive breast implants should be warned of the risk of serious complications, including fatigue, joint pain and the possibility of a rare type of cancer, the Food and Drug Administration said on Wednesday.

Agency officials are urging manufacturers to print a boxed warning on the packaging of the implants, and to provide a checklist spelling out the risks for patients considering surgery. It will be left to doctors to review those risks with women seeking breast implants.

The measures are not mandatory and are now open to public comment and industry input. But the recommendations reflect a growing acknowledgment at the agency that implants may cause more harm in women than previously known.

Several years ago, the agency linked implants to a rare form of immune system cancer called anaplastic large cell lymphoma. In July, at the request of the F.D.A., one manufacturer, Allergan, recalled textured breast implants linked to the cancer.

More recent studies have reported higher rates of autoimmune disease among women with breast implants. Advocates for women with these complications called the F.D.A.’s proposals on Monday “an important step,” but noted that the action is only a recommendation.

“What matters most is what happens next,” said Diana Zuckerman, president of the National Center for Health Research in Washington, who has analyzed breast implant studies and has been advising patients.

She said surgeons should be required to go over the checklist with prospective patients before they put down a deposit.

“If breast implants can cause cancer of the immune system, doesn’t it make sense they can cause other systemic problems of the immune system?” Dr. Zuckerman asked.

Millions of women have implants, silicone sacks filled with saltwater or silicone gel that are used to enlarge the breasts for cosmetic reasons or to rebuild them after a mastectomy for breast cancer.

Breast augmentation with implants is the most popular cosmetic surgical procedure. Some 313,000 augmentations were performed in 2018, a 4 percent increase over the number in 2017. Breast reconstruction after cancer surgery accounts for another 100,000 procedures.

But thousands of women with implants have reported developing debilitating illnesses, such as severe muscle and joint pain, weakness, cognitive difficulties and fatigue — a constellation of symptoms some experts call “breast implant illness.”

Some of the ailments are forms of connective tissue disease, which includes lupus, rheumatoid arthritis and other serious autoimmune conditions.

Dr. Zuckerman has found that most breast implant studies were carried out by manufacturers or plastic surgery associations and did not track long-term outcomes, or lost so many participants to follow-up that results were not meaningful.

The studies focused on well-defined illnesses, she said, ignoring debilitating symptoms that lacked specific diagnoses, and most were too small to detect rare diseases.

Earlier this year, the agency warned two implant manufacturers that they had failed to carry out adequate long-term safety studies of implants, which had been mandated as a condition of their approval.

The proposed checklist and boxed warning were developed in response to demands by patients who testified last March at an advisory panel meeting about illnesses they blamed on their implants.

Breast implants and mammography: what we know and what we don’t know

Elizabeth Santoro, RN, MPH and Dr. Diana Zuckerman

There has been a lot of attention given to mammography screening in recent years. Some of this information has been confusing to women—at what age should I first have a mammogram, how frequently should I have repeat mammograms, and are mammograms even effective? These are questions that women both with and without breast implants have been trying to understand. Despite this confusion, the U.S. Preventive Services Task Force recommends screening every two years for women ages 50-74 who have an average risk of breast cancer. Women at high risk because of family history, BRCA gene mutations, or other reasons should discuss a screening schedule with their doctor.  But, what does this mean for women who have breast implants? Are women with breast implants faced with different risks when undergoing a mammography screening? Will women with implants require special considerations during the procedure?

Delayed Breast Cancer Detection

Breast implants can interfere with the detection of breast cancer, because the implants can obscure the mammography image of a tumor. Implants therefore have the potential to delay the diagnosis of breast cancer. Although mammography can be performed in ways that minimize the interference of the implants, as described below, Miglioretti and her colleagues found that even so, 55% of breast tumors were missed, compared to 33% of tumors for women without implants.1  They also found that among newly diagnosed breast cancer patients who did not have any symptoms, the augmented women had larger tumors than those who did not have implants.

What is the impact of this possible delay in diagnosis?  Research findings have been inconsistent, but a 2013 Canadian systematic review of 12 studies found that women with breast cancer who had breast implants are diagnosed with later-stage cancers than women with breast cancer who did not have implants.2

A delay in diagnosis could result in the woman needing more radical surgery or the delay could be fatal.  A 2013 Canadian meta-analysis of five studies found that if women who had breast augmentation later developed breast cancer, they were more likely to die from it than women diagnosed with breast cancer who did not have breast augmentation.3

These studies indicate that for an individual woman, a delay in diagnosis could potentially result in death, and more research is needed to determine how often that happens, and under what circumstances. From a public health perspective, delays in diagnosis could potentially necessitate more radical surgery: a cancer that could have been treated at an earlier stage with breast-sparing treatments, such as lumpectomy, may instead require a mastectomy.3,4

What are the other possible problems that implants can cause regarding mammography?

A study by FDA scientist Dr. S. Lori Brown and colleagues describes problems that were reported to the FDA related to breast implants and mammography screening.5 The authors found 66 adverse events that were reported as either occurring during the mammogram or involving breast implants interfering with the mammogram. Forty-one reports of either silicone or saline breast implants- – almost two out of three reports– pertained to ruptures that were suspected as happening during mammography. The other 25 reports included delayed breast cancer detection, inability to perform the mammogram due to capsular contracture or because of fear that the implant would rupture, and pain/soreness during and after the procedure.

Description of the FDA Study

This study examined data from the Manufacturer and User Facility Device Experience (MAUDE) database. This FDA database collects mandatory or voluntary reports of medical device adverse events from physicians, breast implant manufactures, consumers, and others. The reports were received between June 1992 and October 2002 for events that occurred between June 1972 and June 2002. The mean age of the implant was 14.5 years, and ranged from 2-29 years.

The use of the MAUDE database has limitations. The FDA does not verify the information that is provided. Therefore, the FDA cannot guarantee that the information is accurate and complete. In addition, in some cases, a doctor and a patient could potentially report the same problem.  On the other hand, most problems are not reported even once, since patient and physician reporting is voluntary. It is well-documented that the vast majority of problems arising from medical products are not reported to the FDA. As a result of these shortcomings, these data cannot be used to calculate the number of new adverse events expected for a given number of people in a defined time period.

Key Implications of the Studies on Implants and Mammograms

Potential Implant Rupture

The FDA warns that all implants will eventually break, and research shows that most women who have implants for ten years or longer will have at least one broken implant.6 The risk of breast implant rupture is known to increase as the implant ages. A study by Holmich and colleagues suggested that during the first ten years a woman has implants, most implants do not break, between 11-20 years most will break, and by the time they are more than 20 years almost all have broken.7 Women with implants have been told that mammography is safe for them, but the results of the Brown study suggest that the risk of rupture can be exacerbated by mammography.

Brown and her colleagues also reviewed the published research on implant rupture during mammography and found an additional 17 cases reported in medical journals. According to the American Society of Plastic Surgery, approximately half of the women who get breast implants are in their 20′s or early 30′s,8 which means that the implants are already broken or vulnerable by the time these women are old enough for screening mammograms.

Mammography may therefore increase the risk of a rupture earlier in the typical lifespan of implants, and the squeezing involved in mammography probably increases the risk of leakage in implants that are already ruptured. The potential risk of rupture or leakage needs to be weighed against the benefits of mammography by each individual woman. For women who are concerned about breast cancer, knowledge of mammography problems might discourage women from getting breast implants, or encourage them to have their implants removed and not replaced. Current guidelines encourage women with breast implants to have regular mammograms provided that the technician knows the woman has implants prior to the procedure and that special techniques are utilized.6 In light of this new research, those guidelines need to be reconsidered, especially for women with silicone gel breast implants, where leakage can cause permanent disfigurement and has unknown health risks.

Avoidance of Mammography

The Brown study also found that implants sometimes make it impossible to perform a mammogram. This can happen for two reasons. First, conditions such as capsular contracture, where the scar tissue around the implant tightens and causes the breast to become hard and misshapen, can make it very difficult or even impossible to perform the mammogram.9, 10 The compression of the breast that is required in order to perform the mammogram can be extremely painful if there is capsular contracture, and in some cases the hardness of the breast makes it impossible to compress the breast for the mammogram. Some women avoid getting mammograms because they are afraid of rupture and the latest research indicates that this is a reasonable concern.

Biomaterials testing of breast implants indicates that implants should only break under the most traumatic circumstances, and yet implants break for no apparent reason, as well as under pressure from mammograms.11 It is difficult to know how much risk a mammogram increases the risk of rupture since so little is understood about why implants break and under what circumstances.

What Does this Mean for Women?

Women considering breast implants and women with breast implants need to be informed consumers, and that includes knowing about the problems that arise from having mammograms with breast implants. This is true for all women, but especially breast cancer patients who may use implants on a healthy breast so that it will match the reconstructed breast after a mastectomy. (Detection of cancer in the reconstructed breast is unlikely to be a problem because mammography is not used after a mastectomy. Since breast cancer survivors are at greater risk for breast cancer in the breast that was not removed, compared to women who have not had breast cancer, survivors should have regular mammograms of the surviving breast, and need to know the risks.

Women with breast implants and those considering breast implants need to know that they will have a different mammography experience than women without implants, to try to improve the accuracy. The special techniques used will push the implant back to try to move it out of the way, and extra views will be taken. Even so, as reported earlier in this article, mammograms performed on women with implants will still miss more tumors than is typical of mammograms for women who do not have implants.7, 12 In addition, women with implants should expect that mammography will require more views and take longer, thus costing more and exposing them to increased levels of radiation. Unfortunately, the most common problem, capsular contracture, can make mammography more painful, less accurate, or even impossible to perform. In such cases other, more expensive tests, such as an MRI or ultrasound, may be required.

Women also need to understand that even if breast implants do not cause contracture or other problems, they will still interfere with mammography and mammograms might still cause rupture and leakage.

The bottom line is that women considering breast implants and those who already have them need to be informed about potential problems with mammography so that they can make the decisions that will help them reduce the risk of breast cancer and avoid the problems that arise with implant breakage and leakage.

For more information on breast implants, see www.breastimplantinfo.org.


Related Content:
What you need to know: Breast cancer, suicide, mastectomy, and breast implants
Summary of: Breast Implants, Self-Esteem, Quality of Life, and the Risk of Suicide
2016 Update: When should women start regular mammograms? 40? 50? And how often is “regular”?