Additional Cancers Linked to Breast Implants

 The FDA issued a safety communication that cancer cases, including squamous cell carcinomas (SCC) and other lymphomas, have been linked to scar tissue around breast implants.

The pathology of these cases differs than that of anaplastic large lymphomas linked to breast implants a decade ago.

A preliminary review of published literature found fewer than 20 cases of SCC and fewer than 30 cases of various lymphomas in the scar tissue around the implant.

Women who have had implants should be aware of symptoms of cancer, which include swelling, pain, lumps or skin changes, the FDA said, noting that some cases emerged years after women received their implants. The SCC cases were linked to both textured and smooth implants, and saline and silicone implants.

FDA warns breast implants linked to rare form of cancer

The Food and Drug Administration (FDA) issued a letter warning health care professionals to check women with breast implants for Anaplastic Large Cell Lymphoma (BIA-ALCL) a rare cancer that usually arises in the scar tissue that forms around implants.

The FDA said at least 457 women in the United States have so far been diagnosed with anaplastic large cell lymphoma, and nine women have died from the disease. Though the number of BIA-ALCL is small compared to the estimated 1.5 million patients who receive breast implants worldwide every year, confirmed data and published information reviewed to date suggests that patients with breast implants have an increased risk of BIA-ALCL.

In most of the cases the patients were diagnosed with BIA-ALCL due to symptoms such as pain, lumps, swelling, or asymmetry that developed after their initial surgical sites were fully healed. These symptoms were due to collection of fluid, or masses surrounding the breast implant. Cytological examination of the fluid and histologic examination of the capsule surrounding the breast implant can lead to the BIA-ALCL diagnosis.

The FDA is asking health care providers to report cases of BIA-ALCL in patients with breast implants. The FDA request health care providers with questions to either email the Division of Industry and Consumer Education (DICE) at DICE@FDA.HHS.GOV, or call 1-800-638-2041 or 301-796-7100.

FDA requires a warning on Gadolinium Contrast Agents

The U.S. Food and Drug Administration (FDA) has issued a new advisory requiring a new class warning and other safety measures for all gadolinium-based contrast agents (GBCAs) for magnetic resonance imaging (MRI) regarding gadolinium remaining in patients’ bodies, including the brain, for months to years after receiving these drugs which may be linked to renal harm.   These agents have been associated with nephrogenic systemic fibrosis in patients with pre-existing renal failure.  Although this complication is rare, it is serious enough to justify the advisory to all professionals and patients.

Although the benefit of all approved GBCAs continues to outweigh any potential risks the FDA now requires several actions to alert health care professionals and patients about gadolinium retention after an MRI using a GBCA, including actions that can minimize problems.  Health care professionals should consider the retention characteristics of each agent when choosing a GBCA for patients who may be at higher risk for gadolinium. These patients include those requiring multiple lifetime doses, pregnant women, children, and patients with inflammatory conditions. FDA suggests fewer repeated GBCA imaging studies when possible, particularly closely spaced MRI studies. However, physicians are advised to not avoid or defer necessary GBCA MRI scans.

Patients, parents, and caregivers should carefully read the new patient Medication Guide that will be given to him before receiving a GBCA. The Medication Guide explains the risks associated with GBCAs.  It also asks the patient to inform health care professional about medical conditions, such as: pregnancy, date of last MRI and number of prior MRI with gadolinium and kidney problems.

All new patients will be provided with the Medical Guide that provides educational information that every patient will be asked to read before receiving a GBCA. FDA will also require manufacturers of GBCAs to conduct human and animal studies to further assess the safety of these contrast agents.

No need to print mammograms on films; FDA

An FDA communiqué to mammography facilities “said that printing breast images to hard-copy film is no longer necessary and can be performed at the discretion of individual centers”. 

Over the past 20 years, there has been significant evolution in mammography, with the shift from screen-film to digital imaging being the most prominent change.

A total of 39 million procedures were performed in the 8,737 mammographic facilities that were accredited by the FDA as of Nov 1, 2015.   Today fewer than 350 screen-film units remain in use in the U.S. The nearly universal availability of computers for viewing of digital images diminishes the need for a facility to maintain a printer.

Today, with many mammograms shared on computer media such as compact discs or via online access, the provision of printed hard copies is becoming obsolete.