FDA Asks Allergan to Voluntarily Recall Breast Implants to Protect Against Rare Cancer
The Food and Drug Administration has requested that the manufacturer voluntarily recall certain breast implants and tissue expanders from the market to protect women from risks such as breast implant-associated anaplastic large cell lymphoma.
BY ALEXANDRA GUADAGNO
PUBLISHED JULY 24, 2019
The Food and Drug Administration (FDA) has requested that Allergan, a breast implant manufacturer, voluntarily recall from the market certain textured models of its breast implants and tissue expanders to protect women from risks associated with these products. This action by the FDA is intended to protect women from breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) by taking specific models of Allergan’s textured breast implants off the U.S. market due to their association with BIA-ALCL.
“Although the overall incidence of BIA-ALCL appears to be relatively low, once the evidence indicated that a specific manufacturer’s product appeared to be directly linked to significant patient harm, including death, the FDA took action to alert the firm to new evidence indicating a recall is warranted to protect women’s health,” said Dr. Amy Abernethy, principal deputy commissioner for the FDA.
Allergan responded to the FDA’s request and has notified the agency that it is issuing a worldwide recall of its BIOCELL textured breast implant products, including:
Natrelle Saline-Filled breast implants
Natrelle Silicone-Filled breast implants
Natrelle Inspira Silicone-Filled breast implants
Natrelle 410 Highly Cohesive Anatomically Shaped Silicone-Filled breast implants
The recall also includes tissue expanders used by patients prior to breast augmentation or reconstruction, including:
Natrelle 133 Plus Tissue Expander
Natrelle 133 Tissue Expander with Suture Tabs
"The recall of these textured implants is a big deal in protecting women from the potential risks of developing, and dying from, this rare type of aggressive lymphoma," said Dr. Joshua Brody, director of the Lymphoma Immunotherapy Program at The Tisch Cancer Institute at Mount Sinai. "While case reports have suggested a potential link between some types of breast implants and this disease, anaplastic lymphoma. For over 20 years, it has taken time to gain sufficient evidence to suggest, and understand, the causality. Some types of implants induces inflammation which can both increase the chance of developing cancer, and also help to 'hide' developing cancers from the immune system. Many cases of implant-associated lymphoma have developed mutations and expression of immune-suppressive proteins which prevent anti-tumor immune cells from clearing the cancer, and these chances likely begin with the inflammation induced by some implants. By preventing further use of these implants, the FDA is helping women to protect themselves from the medically serious and emotionally exhausting effects of these risks."
The FDA has also issued a safety communication today for patients with breast implants – and patients considering breast implants – as well as their health care professionals, outlining the known risks of breast implants and what patients should know when checking for symptoms of BIA-ALCL, such as swelling and pain in their breasts. “The FDA does not recommend removal (of implants) for patients without symptoms due to potential risks, but we provide helpful information for patients and providers to consider when discussing next steps,” said Dr. Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health.
In a July 24 update to its BIA-ALCL webpage, the FDA states that there have been 573 cases of BIA-ALCL and 33 patient deaths from it across the globe; of these cases, 481 are associated with Allergan implants. The FDA’s safety communication statement said that, based on the most current information, including data submitted after an FDA panel meeting in March, “FDA analysis demonstrates that the risk of BIA-ALCL with Allergan BIOCELL textured implants is approximately six times the risk of BIA-ALCL with textured implants from other manufacturers marketing in the U.S., and continued distribution of Allergan’s BIOCELL textured breast products/implants would likely cause serious, adverse health consequences and potentially death from BIA-ALCL."
The recall also is intended to ensure that any remaining products are removed from suppliers’ and doctors’ offices.
“The FDA has been diligently monitoring this issue since we first identified the possible association between breast implants and ALCL in 2011 and, at that time, communicated to patients and providers that there is a risk for women with breast implants, more frequently occurring in women with textured implants, for developing this disease,” said Abernethy. “Based on new data, our team concluded that action is necessary at this time to protect the public health. We will continue to monitor the incidence of BIA-ALCL across other textured and smooth breast implants and tissue expanders as well as other devices intended for use in the breast. If action is needed in the future, we will not hesitate to do what is necessary to protect patients,” she added.
(original article found at www.curetoday.com)
Wings of Hope expanding cancer care services
By Jon Leu
October 14, 2018
Wings of Hope Cancer Support Center was started more than 20 years ago in response to the needs of cancer patients in the Council Bluffs community, a support group that met the social and emotional needs of people who were diagnosed with cancer.
Founder Patti Higginbotham soon observed that the community needed more than a support group for people affected by cancer.
In 1994, Wings of Hope became an official nonprofit organization focused on helping cancer patients, survivors and caregivers. Over the next 24 years, the staff and Board of Directors at Wings of Hope began exponentially expanding the services that were offered, always responding to the needs of cancer patients and their caregivers.
The grassroots efforts of those involved has led to both practical care programming for patients in active cancer treatments and a broad base of psychosocial programming that supports cancer patients at the diagnosis, throughout treatment and in the survivorship phase.
With the American Cancer Society predicting an increase in the numbers of those diagnosed with cancer and those who survive cancer — as well as the increasing recognition that cancer impacts a patient’s mental health — the services offered at Wings of Hope Cancer Support Center are now more important than ever.
When a patient is diagnosed with cancer, it is not just their body that is affected by the disease. The cancer journey also affects the patient’s mental and emotional health. Medical teams are put in place to diagnose the organs being affected by the disease. Wings of Hope Cancer Support Center takes care of the mental and emotional side of a cancer diagnosis.
In addition to the original support groups, Wings offers a plethora of integrative therapy programs for cancer survivors, including counseling/coaching services, healing touch treatments, guided imagery and survivorship rehabilitation programs. Wings has a Hope Chest Renewal Room that contains wigs, scarves, etc., and offers exercise and other health-related classes.
All of the services offered at Wings of Hope are completely free of charge to the patient.
As the number of cancer survivors increases, so does the community need for an organization that can reach out and offer help to these patients. In response to the growing need, Wings of Hope began its first expansion campaign last spring. The goal is to raise funds that would allow Wings to expand for the next five years.
With the growing number of nonprofits in the area, national grants are becoming more and more scarce. Large national cancer organizations have cut many of their grant amounts to smaller community nonprofits. With this, smaller nonprofits face greater financial challenges. To adapt to these changes, Wings of Hope is focusing more on community partnerships and community donors.
Wings of Hope is the only organization of their kind in the southwest Iowa area – and these are exactly the communities that Wings of Hope is reaching. While the hospitals and oncology offices focus on the physical effects of cancer, Wings of Hope focuses on the mental and emotional health of the patient.
Executive Director Carolyn Ettinger said the Wings of Hope expansion campaign goal is $250,000 by the end of the year. Every community partnership and donation is crucial. Wings of Hope remains committed to offering all of its services free of charge to cancer patients, survivors and caregivers. She said the only way to expand their programs and reach more people affected by cancer is through the help of generous donors in the community.
For more information about Wings of Hope Cancer Support Center, please visit wingsofhope.org or call 712-325-8970. For questions or information concerning the expansion campaign or donations, please contact Precious Watson at Watson@wingsofhope.org .
Obesity Linked to 12 Types of Cancer in New Report
Health experts have recommended 10 lifestyle changes, including quitting drinking and limiting the consumption of processed meats, to prevent 12 different cancers linked to obesity in a major new report.
The World Cancer Research Fund (WCRF) assessed decades-worth of evidence and found an association between obesity and cancers of the stomach, mouth and throat, liver, ovary, bowel, gallbladder, kidney, esophagus, pancreas, and womb. Breast cancer after the menopause and advanced prostate cancer were also linked to obesity.
The "Diet, Nutrition, Physical Activity and Cancer: a Global Perspective" report presented at the European Congress on Obesity in Vienna included an updated version of the organization's cancer prevention recommendations, which it dubbed its “blueprint to beat cancer.” It was accompanied by the Cancer Health Check tool, which offers personalized recommendations for how to prevent the disease.
The recommendations included: being a healthy weight; exercising; eating grains, veg, fruit and beans; avoiding high calorie foods; limiting the consumption of red and processed meat and sugar-sweetened drinks, as well as cutting out alcohol. The WCRF also warned against relying on dietary supplements and emphasized the benefits of breastfeeding babies.
Regularly drinking sugar-sweetened drinks was linked to cancer because it can cause weight gain and obesity, the experts said. But being physically active was found to directly protect against cancers of the bowel, womb and, post-menopause, breast, as well as cutting the wider risk of developing other cancers.
Mirroring a 2015 World Health Organization warning that linked the consumption of processed and red meats to forms of cancer including bowel, the report recommended a diet featuring wholegrains, vegetables, fruit and pulses. Red meat should be limited to no more than three portions (350 to 500g cooked servings) a week to prevent bowel cancer, the WCRF said.
Alcohol, meanwhile, was “strongly” associated with cancer of the breast, liver, mouth, bowel, throat, esophagus, and stomach.
And as more countries adopt Western lifestyles with sedentary living and obesity-causing foods, cancer rates are expected to spike 58% by 2035, causing 24 million global deaths per year, the researchers said. However, the onus to prevent cancer does not solely lie with individuals, they stressed, urging governments to prioritize cancer prevention policies.
Susannah Brown, senior science program manager with WCRF, told Newsweek: "This report contains significant findings on how diet, weight and physical activity affect cancer risk and show how important adopting a healthy lifestyle is to reducing cancer risk."
The aim of the report is not to worry people, she said. "We want people to know that what food they eat, what they weigh and how physically active they are can affect their risk and this report gives practical information on what patterns of diet and activity are conducive to reducing the risk of cancer."
Asked whether there is a risk that the public will adopt the attitude that "everything causes cancer" and believe there is no use changing behaviors, she countered: "This report collates over 30 years’ worth of strong scientific evidence and includes data from over 50 million people and so it is a very comprehensive review. It contains information on what positive steps people can take to reduce their risk (the ‘good news’ is that there are things you can do to reduce your cancer risk) and shows that in most cases it isn’t a single food or nutrient that makes a difference–there are no magic bullets–the important thing is what you eat and drink, your weight and how active you are through your lifetime."
"Living a healthy lifestyle in this day and age isn't always easy–it’s often difficult, or hard to find time and this is one reason why we want governments to take action and create environments where it’s easier for people to follow our recommendations and be healthy."
Caroline Cerny, the lead of the Obesity Health Alliance comprised of over 40 health charities, medical colleges and campaign groups, said carrying excess weight can not only raise the risk of cancer, but also type 2 diabetes, heart and liver disease and mental illness.
"It’s clear we need an environment that supports and encourages healthy choices, rather than steering us towards unhealthy options with constant adverts, promotions and offers," she said.
Professor Sir Ian Gilmore, Chair of the Alcohol Health Alliance U.K., welcomed the warning against alcohol use and said: "It is clear from the evidence in the report that drinking alcohol cannot be justified for other health reasons–to prevent heart disease, for example."
And while the report reiterates information we already know (that our lifestyles cut our risk of cancer), professor Linda Bauld, a prevent expert at Cancer Research U.K., said it is important to remember "it's the things you do every day that matter most."
"Building small changes into your daily life, like choosing sugar-free drinks or walking more, can add up to a big difference for your health."
Thank you to everyone who participated in our Journey of Hope Walk!