“Cancer doesn’t wait” as nationwide breast biopsy needle shortage delays care
By Erin Clark
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SALINAS, California (KSBW) — A nationwide recall of breast biopsy needles has caused delays and uncertainty for patients, as breast care centers scramble to address the shortage and prioritize high-risk cases.
“I’m on a national waiting list, and it could be until the end of the year. And I’m thinking, cancer doesn’t wait, you know, and I’m not the only woman in this position,” said Donna Rand-Jordan, who is waiting for a biopsy after her doctors identified tiny calcifications in her breast during her last mammogram.
The nine-gauge stereotactic needle, manufactured by Hologic, was recalled due to the risk of metal and plastic particles being dislodged during use. Dr. Stemerman, a physician at the Salinas Valley Health Nancy Ausonio Breast Health Center, explained how his team adapted to the recall.
“And so we complied with that recall, and we pivoted to using a different needle within Hologic, framework. That could do the same thing, that we can use mantle bands to guide the needle to make to do this, breast biopsies,” Stemerman said.
The replacement Evivo needles require additional steps but are equally effective. However, the sudden shift to these needles created a nationwide shortage.
“And that’s primarily because about 70% of breast centers across the country were using the provider needed. That was needles that were recalled. And so, once we had a shortage, we’ve now placed women on waiting lists and we’re, being allocated needle biopsies from the vendor, on a weekly basis,” Stemerman said.
The FDA added stereotactic needles to its list of device shortages in April. The American College of Radiology (ACR) raised concerns in a letter to the FDA, with CEO Dana H. Smetherma stating:
“The current backlog is not an isolated operational inconvenience, but rather, it represents a broader patient safety and public health concern, particularly in high-volume centers and safety-net institutions where alternatives may be limited or unavailable,” Smetherma said.
Hologic has announced efforts to address the shortage, including expanding manufacturing shifts and expediting orders. However, the company estimates it may take until March of next year to fully meet demand.
At the Salinas Valley Health Nancy Ausonio Breast Health Center, Dr. Stemerman said they are working to minimize delays for patients.
“We have about 40 patients or so on the waiting list. And every week we get, between 10 and 15 needle or needles to do biopsies. And so we are pulling patients off the waiting list as quickly as possible. And so there is there has been a delay, up to a month or two in some cases,” Stemerman said.
For patients like Rand-Jordan, the wait is agonizing.
“And I don’t know. I don’t know, it could be totally benign, or it could be something progressive, progressing, as cancer does. Well, while you wait, cancer progresses and everything. So, I want to know and I want I want my treatment,” Rand-Jordan said.
Breast care centers across the country are prioritizing high-risk patients and working to get all women off the waiting list as quickly as possible.
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