Food and Drug Administration (FDA) Confirms Dangers of Breast Implants<\/strong><\/h3>\n\n\n\nLate last summer, Dr. Binita Ashar, Director of the Office of Surgical and Infection Control Devices in the Center for Devices and Radiological Health, said that the FDA was recommending changes in light of emerging information. <\/p>\n\n\n\n
In an FDA press release, Dr. Ashar stated that:<\/p>\n\n\n\n
\n\n\n- \u201cAs new information has become available about the risks and complications of breast implants, it is critical that women have access to information they need to make informed decisions,\u201d <\/li>\n<\/ul>\n<\/div>\n\n\n\n\n
\n- \u201cAfter working with stakeholders, including patients, today we are recommending format and content changes to breast implant labeling so the information is presented in an easy-to-understand way.\u201d<\/li>\n<\/ul>\n<\/div>\n\n\n\n\n
\n- \u201cIt is important that patients discuss the risks and benefits of breast implants with their health care provider and we hope that these labeling recommendations will help in facilitating these discussions.\u201d <\/li>\n<\/ul>\n<\/div>\n<\/div>\n\n\n\n
The FDA updated its guidance and issued its final orders this year.<\/strong><\/p>\n\n\n\n<\/div>\n\n\n\n![\"\"](\"https:\/\/justiniancom.bigscoots-staging.com\/wp-content\/uploads\/2021\/11\/Food-and-Drug-Agency-Confirms-Dangers-of-Breast-Implants.jpg\")
<\/figure>\n\n\n\n<\/div>\n\n\n\nWhat Do the FDA\u2019s new Black Box Warnings for Breast Implants Require?<\/strong><\/strong><\/strong><\/strong><\/strong><\/h3>\n\n\n\n\nFrom October 27th<\/sup>, 2021 and going forward, the FDA will require that breast implant packaging include:<\/p>\n\n\n\n\n- A boxed warning<\/strong>.<\/li>\n<\/ul>\n\n\n\n
\n- A \u201cpatient decision checklist,\u201d<\/strong> which must be shown and reviewed by patients prior to surgery. This checklist will help ensure that patients understand the benefits, risks, and potential hazards associated with the procedure.<\/li>\n<\/ul>\n\n\n\n
\n- Updated silicone gel-filled breast implant rupture screening information<\/strong> and recommendations<\/strong>. <\/li>\n<\/ul>\n\n\n\n
\n- Device-specific information<\/strong>, including the material and chemical composition of an authorized implant. <\/li>\n<\/ul>\n\n\n\n
\n- A patient device card<\/strong>.<\/li>\n<\/ul>\n<\/div><\/div>\n\n\n\n\n\n
FDA Black Box Warnings for Breast Implants Directed to Patients Who Are Particularly At Risk<\/strong><\/strong><\/strong><\/strong><\/h4>\n<\/div>\n\n\n\n\nAccording to The New York Times, the FDA.\u2019s updated checklist identifies particular types of patients who may be vulnerable to the ill health effects of breast implants, which can lead to:<\/p>\n\n\n\n
\n- Joint Pain<\/li>\n<\/ul>\n\n\n\n
\n- Mental Confusion<\/li>\n<\/ul>\n\n\n\n
\n- Development of critical autoimmune diseases<\/li>\n<\/ul>\n\n\n\n
Specifically, the Food and Drug Administration suggests that breast cancer patients who have or plan to have chemotherapy or radiation treatments are at elevated risk for developing these side-effects.<\/strong> <\/p>\n\n\n\nThis particular guidance may have profound consequences for women who were encouraged to undergo breast reconstruction following partial or total mastectomies. <\/p>\n\n\n\n
The FDA also identified other groups of people whose medical conditions or concerns should preclude them from receiving implants.<\/p>\n\n\n\n
Along with women who have been treated for breast cancer, the list includes:<\/p>\n\n\n\n
\n- People with active infections <\/li>\n\n\n\n
- Patients with existing cancer<\/li>\n\n\n\n
- People with pre-cancer of the breast that has not yet been treated<\/li>\n\n\n\n
- Women who are pregnant or nursing<\/li>\n<\/ul>\n\n\n\n
Women who have diabetes or lupus, an autoimmune disease, also have higher risks of poor or otherwise adverse outcomes.<\/strong><\/p>\n<\/div>\n<\/div>\n\n\n\n\n\nDoes the FDA\u2019s Black Box Warning About the Dangers of Breast Implants Go Far Enough?<\/strong><\/strong><\/strong><\/strong><\/strong><\/h4>\n<\/div>\n\n\n\n\nIn spite of the agency\u2019s decision to improve safety standards for breast implants, the parameters of the \u201cblack box\u201d labeling and patient checklist have garnered some criticism.<\/p>\n\n\n\n
Diana Zuckerman, a National Center for Health Research scientist who used to work with the FDA\u2019s breast implant safety panel, told The New York Times that the checklist is over-broad.<\/p>\n\n\n\n
\u201cIt\u2019s better than nothing, but it\u2019s not as good as it could be,\u201d she said. \u201cThey say things like, \u2018Breast implants are associated with lymphoma,\u2019 but lymphoma is actually caused by the implants,\u201d Zuckerman said. \u201cPeople understand if you say, \u2018Breast implants can cause lymphoma.\u2019\u201d <\/p>\n\n\n\n
Dr. Zuckerman further explained that, even though health-care providers are required to run through the check-list, it remains to be seen whether they will actually explain its implications in-depth. <\/p>\n\n\n\n
Zuckerman said some patient groups are already concerned that cosmetic surgeons may simply give patients the option of going through the check-list, rather than ensuring they read through in detail and acknowledge the risks of receiving implants. <\/p>\n<\/div>\n<\/div>\n\n\n\n
<\/div>\n\n\n\n![\"\"](\"https:\/\/justiniancom.bigscoots-staging.com\/wp-content\/uploads\/2021\/11\/Does-the-FDAs-Black-Box-Warning-About-the-Dangers-of-Breast-Implants-Go-Far-Enough.jpg\")
<\/figure>\n\n\n\n<\/div>\n\n\n\n
\n\n\n\n\n\n <\/strong><\/strong><\/strong><\/strong><\/strong><\/h4>\n<\/div>\n\n\n\n\nNevertheless, some have praised the FDA\u2019s warning requirement as a turn for the better. <\/strong><\/strong><\/strong><\/strong><\/strong><\/strong><\/strong><\/strong><\/strong><\/h5>\n\n\n\nTwo Massachusetts residents told CBS-Boston that they suffered several health complications after receiving silicone breast implants. Meghan Sullivan of Quincy, Massachusetts, said the new warnings are \u201cgreat.\u201d <\/p>\n\n\n\n
Sullivan herself was adversely affected by silicone implants. <\/p>\n\n\n\n
\u201cI got to the point where I couldn\u2019t get out of bed anymore,\u201d Sullivan said in an interview with CBS-Boston. \u201cI was in so much pain.\u201d <\/p>\n\n\n\n
Sullivan said she experienced respiratory problems which prevented her from running. <\/p>\n\n\n\n
Alongside difficulty breathing, she had rashes break out across her body and suffered from chronic fatigue. While Sullivan suspected her breast implants, physicians dismissed her concerns.<\/p>\n\n\n\n
Only in 2017, after finding a doctor half-way across the country, was she able to have her implants removed. Sullivan said she could breathe better \u201cthe second [she] woke up from surgery.\u201d <\/p>\n<\/div>\n<\/div>\n\n\n\n
\n\n\n\n\n\n <\/strong><\/strong><\/strong><\/strong><\/strong><\/h4>\n<\/div>\n\n\n\n\nMany Experts Say That Breast Implants Are Temporary<\/strong><\/strong><\/strong><\/strong><\/strong><\/strong><\/strong><\/strong><\/strong><\/strong><\/h5>\n\n\n\nDespite the changes, and some women\u2019s support for them, experts have cautioned that breast implants are not considered \u201clifetime devices.\u201d <\/p>\n\n\n\n
\n\u201cBreast implants are not lifetime devices,\u201d the FDA\u2019s warning states. <\/strong><\/p>\n\n\n\n\u201cThe longer people have them, the more likely that they will develop complications, some of which will require more surgery.\u201d<\/strong><\/p>\n<\/div><\/div>\n\n\n\n<\/div>\n\n\n\nIn other words, breast implants can degrade over time. The FDA, for instance, has observed that, the longer women have breast implants, the greater their chances for developing complications. <\/p>\n<\/div>\n<\/div>\n\n\n\n
\n1\/3 of Breast Implant Patients<\/strong><\/strong><\/td>One-third of women who have breast implant surgery will experience breast pain, sensitivity or loss thereof, and asymmetry.<\/td><\/tr> 1\/2 of Breast Implant Patients<\/strong><\/td>Half of breast implant patients will experience painful tightening of scar tissue.<\/td><\/tr> 1\/3 of Breast Implant Patients<\/strong><\/td>Will have implants that eventually rupture or leak.<\/td><\/tr> > 1\/2 of Breast Implant Patients<\/strong><\/td>More than half of breast implant patients will require at least another surgery.<\/td><\/tr><\/tbody><\/table><\/figure>\n<\/div><\/div>\n\n\n\nThe New York Times notes that<\/p>\n\n\n\n
What This Means for Consumers Harmed By Surgical Breast Implants<\/strong><\/strong><\/strong><\/strong><\/strong><\/strong><\/h3>\n\n\n\n\n\nSurgical Breast Implant Injury Lawsuits Can Be Complex to Prove<\/strong><\/strong><\/strong><\/strong><\/strong><\/strong><\/h4>\n<\/div>\n\n\n\n\nWinning a mass tort lawsuit for injuries caused by hazardous substances and defective medical devices<\/a> like surgical breast implants can involve proving that manufacturers did not properly warn people taking it of the potential risks. <\/p>\n\n\n\nThat can include investigating medical studies, corporate publications and using testimony from experts on how the medication caused an injury. This is not easily done, particularly when drug companies show up with an army of lawyers.<\/p>\n\n\n\n
But battling bullies is what Justinian & Associates does.<\/em><\/p>\n<\/div>\n<\/div>\n\n\n\n\n\nWe Are Warriors For The Injured<\/strong><\/strong><\/strong><\/strong><\/strong><\/strong><\/strong><\/h4>\n<\/div>\n\n\n\n
- \n
- \u201cAs new information has become available about the risks and complications of breast implants, it is critical that women have access to information they need to make informed decisions,\u201d <\/li>\n<\/ul>\n<\/div>\n\n\n\n\n
- \n
- \u201cAfter working with stakeholders, including patients, today we are recommending format and content changes to breast implant labeling so the information is presented in an easy-to-understand way.\u201d<\/li>\n<\/ul>\n<\/div>\n\n\n\n\n
- \n
- \u201cIt is important that patients discuss the risks and benefits of breast implants with their health care provider and we hope that these labeling recommendations will help in facilitating these discussions.\u201d <\/li>\n<\/ul>\n<\/div>\n<\/div>\n\n\n\n
The FDA updated its guidance and issued its final orders this year.<\/strong><\/p>\n\n\n\n
<\/div>\n\n\n\n<\/figure>\n\n\n\n<\/div>\n\n\n\nWhat Do the FDA\u2019s new Black Box Warnings for Breast Implants Require?<\/strong><\/strong><\/strong><\/strong><\/strong><\/h3>\n\n\n\n
\nFrom October 27th<\/sup>, 2021 and going forward, the FDA will require that breast implant packaging include:<\/p>\n\n\n\n
- \n
- A boxed warning<\/strong>.<\/li>\n<\/ul>\n\n\n\n
- \n
- A \u201cpatient decision checklist,\u201d<\/strong> which must be shown and reviewed by patients prior to surgery. This checklist will help ensure that patients understand the benefits, risks, and potential hazards associated with the procedure.<\/li>\n<\/ul>\n\n\n\n
- \n
- Updated silicone gel-filled breast implant rupture screening information<\/strong> and recommendations<\/strong>. <\/li>\n<\/ul>\n\n\n\n
- \n
- Device-specific information<\/strong>, including the material and chemical composition of an authorized implant. <\/li>\n<\/ul>\n\n\n\n
- \n
- A patient device card<\/strong>.<\/li>\n<\/ul>\n<\/div><\/div>\n\n\n\n\n\n
FDA Black Box Warnings for Breast Implants Directed to Patients Who Are Particularly At Risk<\/strong><\/strong><\/strong><\/strong><\/h4>\n<\/div>\n\n\n\n
\nAccording to The New York Times, the FDA.\u2019s updated checklist identifies particular types of patients who may be vulnerable to the ill health effects of breast implants, which can lead to:<\/p>\n\n\n\n
- \n
- Joint Pain<\/li>\n<\/ul>\n\n\n\n
- \n
- Mental Confusion<\/li>\n<\/ul>\n\n\n\n
- \n
- Development of critical autoimmune diseases<\/li>\n<\/ul>\n\n\n\n
Specifically, the Food and Drug Administration suggests that breast cancer patients who have or plan to have chemotherapy or radiation treatments are at elevated risk for developing these side-effects.<\/strong> <\/p>\n\n\n\n
This particular guidance may have profound consequences for women who were encouraged to undergo breast reconstruction following partial or total mastectomies. <\/p>\n\n\n\n
The FDA also identified other groups of people whose medical conditions or concerns should preclude them from receiving implants.<\/p>\n\n\n\n
Along with women who have been treated for breast cancer, the list includes:<\/p>\n\n\n\n
- \n
- People with active infections <\/li>\n\n\n\n
- Patients with existing cancer<\/li>\n\n\n\n
- People with pre-cancer of the breast that has not yet been treated<\/li>\n\n\n\n
- Women who are pregnant or nursing<\/li>\n<\/ul>\n\n\n\n
Women who have diabetes or lupus, an autoimmune disease, also have higher risks of poor or otherwise adverse outcomes.<\/strong><\/p>\n<\/div>\n<\/div>\n\n\n\n
\n\nDoes the FDA\u2019s Black Box Warning About the Dangers of Breast Implants Go Far Enough?<\/strong><\/strong><\/strong><\/strong><\/strong><\/h4>\n<\/div>\n\n\n\n
\nIn spite of the agency\u2019s decision to improve safety standards for breast implants, the parameters of the \u201cblack box\u201d labeling and patient checklist have garnered some criticism.<\/p>\n\n\n\n
Diana Zuckerman, a National Center for Health Research scientist who used to work with the FDA\u2019s breast implant safety panel, told The New York Times that the checklist is over-broad.<\/p>\n\n\n\n
\u201cIt\u2019s better than nothing, but it\u2019s not as good as it could be,\u201d she said. \u201cThey say things like, \u2018Breast implants are associated with lymphoma,\u2019 but lymphoma is actually caused by the implants,\u201d Zuckerman said. \u201cPeople understand if you say, \u2018Breast implants can cause lymphoma.\u2019\u201d <\/p>\n\n\n\n
Dr. Zuckerman further explained that, even though health-care providers are required to run through the check-list, it remains to be seen whether they will actually explain its implications in-depth. <\/p>\n\n\n\n
Zuckerman said some patient groups are already concerned that cosmetic surgeons may simply give patients the option of going through the check-list, rather than ensuring they read through in detail and acknowledge the risks of receiving implants. <\/p>\n<\/div>\n<\/div>\n\n\n\n
<\/div>\n\n\n\n<\/figure>\n\n\n\n<\/div>\n\n\n\n
\n\n\n\n\n\n<\/strong><\/strong><\/strong><\/strong><\/strong><\/h4>\n<\/div>\n\n\n\n
\nNevertheless, some have praised the FDA\u2019s warning requirement as a turn for the better. <\/strong><\/strong><\/strong><\/strong><\/strong><\/strong><\/strong><\/strong><\/strong><\/h5>\n\n\n\n
Two Massachusetts residents told CBS-Boston that they suffered several health complications after receiving silicone breast implants. Meghan Sullivan of Quincy, Massachusetts, said the new warnings are \u201cgreat.\u201d <\/p>\n\n\n\n
Sullivan herself was adversely affected by silicone implants. <\/p>\n\n\n\n
\u201cI got to the point where I couldn\u2019t get out of bed anymore,\u201d Sullivan said in an interview with CBS-Boston. \u201cI was in so much pain.\u201d <\/p>\n\n\n\n
Sullivan said she experienced respiratory problems which prevented her from running. <\/p>\n\n\n\n
Alongside difficulty breathing, she had rashes break out across her body and suffered from chronic fatigue. While Sullivan suspected her breast implants, physicians dismissed her concerns.<\/p>\n\n\n\n
Only in 2017, after finding a doctor half-way across the country, was she able to have her implants removed. Sullivan said she could breathe better \u201cthe second [she] woke up from surgery.\u201d <\/p>\n<\/div>\n<\/div>\n\n\n\n
\n\n\n\n\n\n<\/strong><\/strong><\/strong><\/strong><\/strong><\/h4>\n<\/div>\n\n\n\n
\nMany Experts Say That Breast Implants Are Temporary<\/strong><\/strong><\/strong><\/strong><\/strong><\/strong><\/strong><\/strong><\/strong><\/strong><\/h5>\n\n\n\n
Despite the changes, and some women\u2019s support for them, experts have cautioned that breast implants are not considered \u201clifetime devices.\u201d <\/p>\n\n\n\n
\n\u201cBreast implants are not lifetime devices,\u201d the FDA\u2019s warning states. <\/strong><\/p>\n\n\n\n
\u201cThe longer people have them, the more likely that they will develop complications, some of which will require more surgery.\u201d<\/strong><\/p>\n<\/div><\/div>\n\n\n\n
<\/div>\n\n\n\nIn other words, breast implants can degrade over time. The FDA, for instance, has observed that, the longer women have breast implants, the greater their chances for developing complications. <\/p>\n<\/div>\n<\/div>\n\n\n\n
\n1\/3 of Breast Implant Patients<\/strong><\/strong><\/td> One-third of women who have breast implant surgery will experience breast pain, sensitivity or loss thereof, and asymmetry.<\/td><\/tr> 1\/2 of Breast Implant Patients<\/strong><\/td> Half of breast implant patients will experience painful tightening of scar tissue.<\/td><\/tr> 1\/3 of Breast Implant Patients<\/strong><\/td> Will have implants that eventually rupture or leak.<\/td><\/tr> > 1\/2 of Breast Implant Patients<\/strong><\/td> More than half of breast implant patients will require at least another surgery.<\/td><\/tr><\/tbody><\/table><\/figure>\n<\/div><\/div>\n\n\n\n The New York Times notes that<\/p>\n\n\n\n
What This Means for Consumers Harmed By Surgical Breast Implants<\/strong><\/strong><\/strong><\/strong><\/strong><\/strong><\/h3>\n\n\n\n
\n\nSurgical Breast Implant Injury Lawsuits Can Be Complex to Prove<\/strong><\/strong><\/strong><\/strong><\/strong><\/strong><\/h4>\n<\/div>\n\n\n\n
\nWinning a mass tort lawsuit for injuries caused by hazardous substances and defective medical devices<\/a> like surgical breast implants can involve proving that manufacturers did not properly warn people taking it of the potential risks. <\/p>\n\n\n\n
That can include investigating medical studies, corporate publications and using testimony from experts on how the medication caused an injury. This is not easily done, particularly when drug companies show up with an army of lawyers.<\/p>\n\n\n\n
But battling bullies is what Justinian & Associates does.<\/em><\/p>\n<\/div>\n<\/div>\n\n\n\n
\n\nWe Are Warriors For The Injured<\/strong><\/strong><\/strong><\/strong><\/strong><\/strong><\/strong><\/h4>\n<\/div>\n\n\n\n
- Development of critical autoimmune diseases<\/li>\n<\/ul>\n\n\n\n
- Mental Confusion<\/li>\n<\/ul>\n\n\n\n
- Joint Pain<\/li>\n<\/ul>\n\n\n\n
- A patient device card<\/strong>.<\/li>\n<\/ul>\n<\/div><\/div>\n\n\n\n
- Device-specific information<\/strong>, including the material and chemical composition of an authorized implant. <\/li>\n<\/ul>\n\n\n\n
- Updated silicone gel-filled breast implant rupture screening information<\/strong> and recommendations<\/strong>. <\/li>\n<\/ul>\n\n\n\n
- A \u201cpatient decision checklist,\u201d<\/strong> which must be shown and reviewed by patients prior to surgery. This checklist will help ensure that patients understand the benefits, risks, and potential hazards associated with the procedure.<\/li>\n<\/ul>\n\n\n\n
- A boxed warning<\/strong>.<\/li>\n<\/ul>\n\n\n\n
- \u201cIt is important that patients discuss the risks and benefits of breast implants with their health care provider and we hope that these labeling recommendations will help in facilitating these discussions.\u201d <\/li>\n<\/ul>\n<\/div>\n<\/div>\n\n\n\n
- \u201cAfter working with stakeholders, including patients, today we are recommending format and content changes to breast implant labeling so the information is presented in an easy-to-understand way.\u201d<\/li>\n<\/ul>\n<\/div>\n\n\n\n
![\"\"](\"https:\/\/justiniancom.bigscoots-staging.com\/wp-content\/uploads\/2021\/11\/The-Time-to-Act-is-Now.jpg\")
<\/figure>\n\n\n\n