The federal Food and Drug Administration has ordered breast implant manufacturers to put “black box” warnings on their product packaging, and has instructed retailers to sell only sell implants to health-care providers who tell patients the risks of augmentation before surgery.
The FDA has been working on this guidance since 2019, after it heard from nearly two-dozen women who claimed that their health was harmed by surgical silicone breast implants.
Food and Drug Administration (FDA) Confirms Dangers of Breast Implants
Late 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.
In an FDA press release, Dr. Ashar stated that:
- “As 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,”
- “After 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.”
- “It 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.”
The FDA updated its guidance and issued its final orders this year.
What Do the FDA’s new Black Box Warnings for Breast Implants Require?
From October 27th, 2021 and going forward, the FDA will require that breast implant packaging include:
- A boxed warning.
- A “patient decision checklist,” 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.
- Updated silicone gel-filled breast implant rupture screening information and recommendations.
- Device-specific information, including the material and chemical composition of an authorized implant.
- A patient device card.
FDA Black Box Warnings for Breast Implants Directed to Patients Who Are Particularly At Risk
According to The New York Times, the FDA.’s updated checklist identifies particular types of patients who may be vulnerable to the ill health effects of breast implants, which can lead to:
- Joint Pain
- Mental Confusion
- Development of critical autoimmune diseases
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.
This particular guidance may have profound consequences for women who were encouraged to undergo breast reconstruction following partial or total mastectomies.
The FDA also identified other groups of people whose medical conditions or concerns should preclude them from receiving implants.
Along with women who have been treated for breast cancer, the list includes:
- People with active infections
- Patients with existing cancer
- People with pre-cancer of the breast that has not yet been treated
- Women who are pregnant or nursing
Women who have diabetes or lupus, an autoimmune disease, also have higher risks of poor or otherwise adverse outcomes.
Does the FDA’s Black Box Warning About the Dangers of Breast Implants Go Far Enough?
In spite of the agency’s decision to improve safety standards for breast implants, the parameters of the “black box” labeling and patient checklist have garnered some criticism.
Diana Zuckerman, a National Center for Health Research scientist who used to work with the FDA’s breast implant safety panel, told The New York Times that the checklist is over-broad.
“It’s better than nothing, but it’s not as good as it could be,” she said. “They say things like, ‘Breast implants are associated with lymphoma,’ but lymphoma is actually caused by the implants,” Zuckerman said. “People understand if you say, ‘Breast implants can cause lymphoma.’”
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.
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.
Nevertheless, some have praised the FDA’s warning requirement as a turn for the better.
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 “great.”
Sullivan herself was adversely affected by silicone implants.
“I got to the point where I couldn’t get out of bed anymore,” Sullivan said in an interview with CBS-Boston. “I was in so much pain.”
Sullivan said she experienced respiratory problems which prevented her from running.
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.
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 “the second [she] woke up from surgery.”
Many Experts Say That Breast Implants Are Temporary
Despite the changes, and some women’s support for them, experts have cautioned that breast implants are not considered “lifetime devices.”
“Breast implants are not lifetime devices,” the FDA’s warning states.
“The longer people have them, the more likely that they will develop complications, some of which will require more surgery.”
In 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.
|1/3 of Breast Implant Patients
|One-third of women who have breast implant surgery will experience breast pain, sensitivity or loss thereof, and asymmetry.
|1/2 of Breast Implant Patients
|Half of breast implant patients will experience painful tightening of scar tissue.
|1/3 of Breast Implant Patients
|Will have implants that eventually rupture or leak.
|> 1/2 of Breast Implant Patients
|More than half of breast implant patients will require at least another surgery.
The New York Times notes that
What This Means for Consumers Harmed By Surgical Breast Implants
Surgical Breast Implant Injury Lawsuits Can Be Complex to Prove
Winning a mass tort lawsuit for injuries caused by hazardous substances and defective medical devices like surgical breast implants can involve proving that manufacturers did not properly warn people taking it of the potential risks.
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.
But battling bullies is what Justinian & Associates does.
We Are Warriors For The Injured
As our record demonstrates, we have the legal knowledge, the experience, the resources, experience and trained investigators to take on adversaries of any size.
All we do is fight for injured victims. Our only goal is justice for our clients, whatever that means for them. And we do not accept defeat. Unless we get you money for your injuries, you don’t pay us a dime.
The Time to Act is Now
Your rights can be lost if you wait.
There are laws that limit how much time you have to file a lawsuit after being injured. They are known as statutes of limitation. They may apply to your lawsuit to recover for your talc injuries. The countdown may already have begun.
Every year, hundreds of thousands of women get breast implants—many for cosmetic reasons, and many to recover from cancer-related mastectomies.
Although implant manufacturers have known of the dangers of silicone implants for years, many have failed to adequately convey the risk to patients.
Countless women, including those trying to recover from breast cancer, have suffered serious, adverse health effects from implants that were poorly designed or not appropriate for persons with certain medical conditions.
If you were hurt by a bad product or negligent medical provider, you do not have to bear the expense of recovery alone. You may be entitled to damages, which can reimburse you for a bad surgery, pay for hospital bills, and help ease your emotional pain and suffering.
Call, text or email us for a free consultation, with no obligation. Speak to a Texas personal injury attorney from Justinian & Associates (not a “screener” or paralegal) to understand your rights.