Tag Archives: lymphoma

Patients Must Be Warned of Breast Implant Risks, F.D.A. Says

We Are Quoted, , , ,

Roni Caryn Rabin, The New York Times: October 27, 2021

Federal regulators on Wednesday placed so-called black box warnings on breast implant packaging and told manufacturers to sell the devices only to health providers who review the potential risks with patients before surgery.

Both the warnings and a new checklist that advises patients of the risks and side effects state that breast implants have been linked to a cancer of the immune system and to a host of other chronic medical conditions, including autoimmune diseases, joint pain, mental confusion, muscle aches and chronic fatigue.

Startlingly, the checklist identifies particular types of patients who are at higher risk for illness after breast implant surgery. The group includes breast cancer patients who have had, or plan to have, chemotherapy or radiation treatments.

That represents a large percentage of women who until now were encouraged to have breast reconstruction with implants following their treatment.

The Food and Drug Administration is also requiring manufacturers for the first time to disclose the ingredients used to make breast implants, information that patient advocates have long sought. The information must be made public in 30 days.

It is not clear how the new requirements will be enforced, and patients are highly unlikely to ever see a warning label on a packaged sterile medical device that is usually handled only by a surgeon. F.D.A. officials said in a statement that the patients “must be given the opportunity” to sign the checklist.

[….]

Reactions to the new requirements were mixed. While some doctors welcomed the new warning system, others worried that the potential risks and side effects would not be conveyed adequately by plastic surgeons who were eager to reassure patients the procedure is safe and that the new checklist would be handled in a dismissive manner.

Critics also said the checklist was overly long and written in obtuse language. “It’s better than nothing, but it’s not as good as it could be,” said Diana Zuckerman, a scientist who heads the National Center for Health Research and was a member of the working group that advised the F.D.A. on implant safety.

“They say things like, ‘Breast implants are associated with lymphoma,’ but lymphoma is actually caused by the implants,” Dr. Zuckerman said. “People understand it if you say, ‘Breast implants can cause lymphoma.’”

She worried that surgeons would not take the time to adequately review the information with patients.

“What if a surgeon says, ‘Here’s a checklist — I know it’s long, so it’s up to you if you want to read it or not’?” Dr. Zuckerman said. “Patient groups are very concerned that will happen.”

[….]

To read the entire article, click here.

Patients Continue to Be Inadequately Informed of Risk for Breast Implant-Associated ALCL

We Are Quoted, , , , ,

Christina Bennet, MS, Cancer Therapy Advisor: February 8, 2021

Although the risk for breast implant-associated anaplastic large-cell lymphoma (BIA-ALCL) has been well-documented, patients considering breast implants continue to be inadequately informed of the propensity for disease development. Awareness of BIA-ALCL has risen since 2020, but adequate safeguards have not yet been put in place, according to experts in the field.

“There have been efforts made [to ensure patients are informed], but they have not been successful,” Diana Zuckerman, PhD, president of the National Center for Health Research (NCHR), said in an interview with Cancer Therapy Advisor.

The most recent effort to more frontally disclose the risk for BIA-ALCL is a final guidance document released by the FDA on September 28, 2020.1 The guidance, which applies to all breast implants, advised breast implant manufacturers to add a black box warning that mentions the risks associated with breast implants such as BIA-ALCL. In the guidance, the FDA also encouraged manufacturers to incorporate a patient decision checklist in the labeling to “better ensure certain information is received and understood by patients.”1,2 Manufacturers, however, are not required to follow these recommendations.

Zuckerman, who is a member of the Breast Implant Working Group, said she was surprised by the FDA’s decision to recommend rather than require these facets of the guidance. “We don’t have the answer to that question other than we have talked to FDA officials who said that at least some of this will at some point be a requirement, but we don’t know when that is,” she said.

With no mandates in place to ensure that patients receive information about the risks for BIA-ALCL—among other breast implant-associated complications—upfront, the industry is left to educate—and this does not seem to be working.

Patient advocates Terri McGregor and Jennifer Cook, both of whom have received a BIA-ALCL diagnosis, discussed a misleading patient brochure that has further contributed to the misinformation about breast implant-associated cancer risk. Sold online by the American Society of Plastic Surgeons (ASPS), the brochure featured the symbol for breast reconstruction awareness—a modified pink ribbon—and the slogan “Closing the loop on breast cancer.”3

The brochure was sponsored by several companies, including 2 prominent breast implant manufacturers, Allergan and Mentor. Though the document was promoted on Twitter by the ASPS and users were encouraged users to “stock up now” ahead of Breast Reconstruction Day,3,4  it notably made no mention of BIA-ALCL—not even on the page that describes the risks and safety issues associated with breast implants.

Conflicts of Interest Cloud Risk Disclosure

[…]

Eric Swanson, MD, a plastic surgeon at the Swanson Center for Cosmetic Surgery in Leawood, Kansas, told Cancer Therapy Advisor that plastic surgeons’ financial ties to breast implant manufacturers are part of the reason why they have been slow to respond to the issue of BIA-ALCL. “There’s a big problem with conflict of interest in plastic surgery. Once [a person has] taken funds from a company, it is very rare for the taker to be critical of that company,” Swanson said.

[….]

Zuckerman described the ASPS brochure as “terribly” out of date. “The Institute of Medicine report is more than 20 years old, and there has been a great deal of research since then,” she said.

[….]

The ASPS Brochure: Current Status

When Cancer Therapy Advisor inquired about the content of the brochure, an ASPS representative agreed that the information was “outdated” and removed the brochure from sale on its website.

Enclosed in the ASPS brochure was a list of websites that included breastimplantsafety.org, which—despites its domain name—did not include any safety information about breast implants. Instead, the domain redirected users to a different domain, smartbeautyguide.com, the patient site for The Aesthetic Society, a professional organization for plastic surgeons. A representative for The Aesthetic Society told Cancer Therapy Advisor that breastimplantsafety.org was active until 2015, when it migrated to their patient site, Smart Beauty Guide.

“We have been developing and will launch our new Aesthetic Society website that will include a dedicated section for patient education,” the representative wrote in an email. Within days of being contacted by Cancer Therapy Advisor, The Aesthetic Society updated the breastimplantsafety.org domain name to direct users to an existing page that provides resources about breast implants, including information about BIA-ALCL and breast implant illness, a systemic condition characterized by a wide range of symptoms that is currently under FDA investigation.18

Read the full article here