Brentwood woman played role in changing views on surgical tool linked to cancer
January 11, 2017 12:00 AM
By Kris B. Mamula / Pittsburgh Post-Gazette
A Pittsburgh-area woman whose experience helped curtail health insurance coverage in three states for a surgical tool linked to cancer died of the disease Friday at age 57 at her home.
Brentwood resident Bonnie Davis said, in a 2014 interview, that she was fit and healthy when she underwent a hysterectomy for the treatment of uterine fibroids on Feb. 1, 2012. Six days later, her doctor told her that cancer cells had been found in tissue removed during the procedure and she would have to start immediate chemotherapy.
Used in Ms. Davis’ surgery was a hand-held device called a power morcellator, which uses tiny blades to mince uterine tissue for easy removal during minimally invasive hysterectomies and other gynecologic procedures. Research has linked use of the device to the spread of cancer cells that are otherwise undetectable.
Ms. Davis said, in the 2014 interview, that she was diagnosed with leiomyosarcoma, an aggressive form of cancer with a poor prognosis.
About 600,000 hysterectomies are performed annually and the percentage of cases done in a minimally invasive manner — which often include the use of power morcellation — increased to about 63 percent in 2012 from 30 percent in 2002, according to AAGL, a Cypress, Calif.-based trade group representing gynecologists and others. Minimally invasive gynecologic surgery causes less blood loss, fewer infections and speeds recovery when compared to traditional surgery and it’s preferred by many women.
For that reason, AAGL and the Washington, D.C., professional group American College of Obstetricians and Gynecologists say power morcellation continues to have a role in gynecologic surgery.
Center Valley, Pa.-based Olympus America Inc. in November received FDA approval for a containment device that is designed to prevent the spread of cancer cells during power morcellation.
But critics of the surgical tool question the effectiveness of the Olympus shield, and are advocating for a complete ban on the use of power morcellation.
The Food and Drug Administration has reviewed the device’s hazards, but stopped short of a ban.
Instead, the FDA issued a safety advisory in April 2014 to doctors and patients, saying the morcellator’s risk of spreading cancer was about 1-in-350 women undergoing the procedure — far higher than the previous estimate of 1-in-10,000 to 1-in-20,000 women.
Cardiothoracic surgeon Hooman Noorchashm has been advocating for a ban of all uses of power morcellation because of the cancer risk it poses.
Dr. Noorchashm and his wife Amy, an anesthesiologist and surgical intensivist, underwent the same procedure as Ms. Davis at Brigham and Women’s Hospital in Boston in October 2013. Like Ms. Davis, Amy Reed was diagnosed with leiomyosarcoma after a power morcellator was used in her procedure.
Two of the Noorchashms’ six children stood at their father’s side in July 2014 as Dr. Noorchashm urged the FDA to ban the surgical tool at a hearing. The family later moved to Philadelphia from Boston to be closer to family, where Amy Reed continues to battle cancer.
Within days of the FDA’s advisory in April 2014, Johnson & Johnson’s Ethicon Inc. unit, among the biggest manufacturers of the morcellation devices, suspended worldwide sales, distribution and marketing of the tool. The company withdrew the product from the market in July 2014, but the withdrawal didn’t affect other makers of the tool.
The FDA updated its safety advisory in November 2014 by requiring manufacturers to affix to the devices a so-called black box warning, notifying doctors of the cancer risk.
And in September 2014, Pittsburgh-based Highmark, the nation’s fourth largest Blues plan, became among the first insurers in the country to stop paying doctors for gynecologic procedures using the power morcellator. UPMC Health Plan, Aetna and other insurers also stopped paying doctors for the procedure.
Highmark President and CEO David Holmberg said in a December 2014 interview with the Wall Street Journal that “one of our people went through this,” suffering the unexpected consequences of power morcellation. He didn’t mention Ms. Davis by name, but she worked as an administrative assistant at Highmark for more than 20 years, including more than 10 years for former chief medical officer Don Fischer, who she talked with about the procedure.
He remembered her this week as “highly professional and in every way a business partner.” He also praised her courage in becoming an outspoken critic of power morcellation after her surgery. Ms. Davis said she would never have consented to the procedure had she’d known the risks.
“She provided incredible support and judgement,” Dr. Fischer said. “She never let on she had a bad day. I thought the world of her. She made me successful.”
As Ms. Davis underwent chemotherapy and radiation, her treatment experience accelerated Highmark’s research into patient safety and related effects of the device, which led to the insurer’s ban on reimbursement for procedures using the power morcellator, Dr. Fischer said.
The ban affects 5.2 million Highmark members in Pennsylvania, West Virginia and Delaware.
Ms. Davis was born in Pittsburgh on Sept. 15, 1959, and raised in the city’s Allentown section. She attended Indiana University of Pennsylvania and a business school before starting her career at Highmark.
She told her husband Jim O’Neill, 58, that she loved her job at Highmark and planned to work until she was 70. The couple was together 32 years — her name is tattooed on his arm.
Mr. O’Neill remembered his wife as athletic and devoted to her Roman Catholic faith. Ms. Davis often attended daily Mass during her lunch break at St. Mary of Mercy Church on Stanwix Street, Downtown, he said. She also loved swimming and the sun, which she said reminded her of God’s blessings.
“I just loved her so, so, so much,” Mr. O’Neill said. “She was everything to me.”
Ms. Davis died surrounded by her family at home. In addition to her husband, she is survived by her mother, Lois Heller, of Brentwood; son Kenneth Davis, of Upper St. Clair; daughter Cynthia Donaldson, of Brentwood; and stepdaughter Dana O’Neill, of Baldwin Borough.
A funeral Mass was scheduled for 10 a.m. Wednesday at St. Stanislaus Kostka Church in the Strip District.
Kris B. Mamula: email@example.com or 412-263-1699
Correction, posted Jan. 11, 2017: Story has been changed to correct Amy Reed’s name and the number of children who accompanied their father at the FDA hearing.
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