The FDA’s recommendations are aimed at helping individuals and patients with breast cancer make better informed decisions about the decision to receive breast implants, according to experts.
The Food and Drug Administration’s (FDA) recent guidance regarding the risks associated with breast implants is a significant achievement in ensuring that patients with breast cancer who are considering reconstructive surgery are well educated and have realistic expectations about the dangers linked to the prosthesis.
“The FDA’s recommendations represent an enormous step forward in improving patient consent and promoting shared-decision making by ensuring a reasonable understanding of risks and benefits of breast implants,” Dr. Mark W. Clemens, associate vice president of perioperative services at University of Texas MD Anderson Cancer Center in Houston, said in an interview with CURE®.
The agency last week issued updated recommendations to strengthen safety requirements for all approved breast implants.
The recommendations, according to Clemens, include a formalized black-box warning, updated long-term surveillance and screening recommendations, as well as a detailed list of implant materials and ingredients used in the device. Moreover, the FDA has asked breast implant manufacturers to develop patient checklists specific to their products and ensure that physicians are reviewing said checklist with their patients.
“Traditionally, the FDA has not been prescriptive on the informed consent process and this standardizes that conversation amongst all plastic surgeons placing breast implants,” he said.
The updated guidance is in response to the risk of health issues that can arise from implant use: breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) and breast implant illness (BII), an autoimmune condition that can result in brain fog, fatigue, rash, and muscle or joint pain.
“The recommendations are being made based on concerns that some patients are not receiving and/or understanding information regarding the benefits and risks of breast implants,” Dr. Umar Choudry, an associate professor of plastic and reconstructive surgery in the Department of Surgery at University of Minnesota Medical School, said in an interview with CURE®. “It is all to better inform patients so that they make better choices for themselves.”
Two years in the making
In 2019, the FDA General and Plastic Surgery Devices Advisory Panel convened to hear from several women who developed various illnesses, including BIA-ALCL, after receiving implants.
The aim, according to Choudry, was to discuss the long-term risks and benefits of breast implants indicated for breast augmentation and reconstruction.
Then, in the fall of 2020, the agency issued its guidance detailing its initial recommendations.
Now, more than two years after the panel meeting, the FDA has released more updates and suggestions.
“The FDA proposed the black-box warnings and at the same time allowed a period of feedback by which patients, surgeons, and manufacturers could weigh in on the recommended changes and make suggestions,” Clemens explained, regarding the two-year period. “The FDA took these suggestions into account in their safety communication which formalized and implemented the recommendations.”
Improving the information
Choudry highlighted that these, and any future steps, taken by the FDA are to better inform patients and provide them enough accurate information to make better decisions for themselves.
“These recommendations only suggest incorporating steps to document and provide easy-to-understand information to prospective patients, but do not add any new information being discussed with patients,” he said.
Moreover, Choudry noted, these recommendations improve the consent process.
In the past, he explained, the consent process normally included discussing potential issues, safety concerns and/or complications associated with breast implants. However, now there is a push to implement a more standardized and well documented process.
A reduction in the number of breast reconstructions?
The new guidance, according to Clemens, will not necessarily influence the decision of patients with breast cancer to forgo reconstruction. Instead, it will provide patients with the knowledge to decide they feel is best for them.
In fact, Clemens noted that less than half of the women who undergo mastectomy for breast cancer are offered breast reconstructive surgery. And less than 20% undergo immediate reconstruction.
“In our institution’s experience, more data and information has not led to less reconstructions, but it has ensured more educated patients able to better participate in their own care,” he said.
The science around breast reconstruction, breast implant technology and outcomes data are constantly evolving, according to Choudry. He continued and further explained that research is always happening and any information that indicates a potential harm to patients is acted upon quickly to change or update patients care decisions.
“Constant vigilance and good quality research are the key to learning, improving, and providing safe patient care now and for the future,” he concluded.
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