FDA Orders Black Box Warnings on Breast Implantation

• “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.” 

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.” 

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. 

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

Our Texas and San Antonio mass tort lawyers have successfully represented many victims injured by dangerous pharmaceuticals and other hazardous substances. That’s exactly why we were founded.

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.