Bipartisan Congressional Committee Demands Investigation of Power Morcellator Dangers from FDA
A 12-member bipartisan Congressional group sent a letter on Friday, August 7th, to the U.S. Government Accountability Office (GAO), insisting that the group open an investigation with the Food and Drug Administration regarding the real dangers of power morcellators.
“Hundreds, if not thousands of women in America are dead because of a medical device known as the laparoscopic power morcellator,” the letter stated. Included in the letter, the 12 Congress members wanted further information regarding:
The FDA’s 510(k) approval process, and how the “fast track” can identify potential medical device problems;
Whether or not medical device reporting regulations were appropriately followed to protect patients;
What the standards of training are regarding these robotic devices; and
What steps the FDA takes after issuing a black box warning, as it has for many drugs and medical devices in the past.
The bipartisan letter added that the FDA’s warning about power morcellators “came decades after some studies were already pointing to a serious problem.”
If the GAO opens an investigation into the FDA’s approval of power morcellator devices, it could change how the FDA approves medical devices in the future. Morcellation surgery, performed with a power morcellator, is supposed to be a simple, non-invasive procedure in which the laparoscopic device and most commonly either removes uterine fibroids – which can cause pain during menstruation – or perform minimally-invasive hysterectomies. Gynecological surgeons claim that the main problem is not the tool itself, but the fact that there are no good tests to distinguish between a uterine fibroid, which is benign, and a cancerous tumor.
Last year, the FDA released information that its original estimate of 1 in 7,000 women developing cancer after power morcellator surgery for misdiagnosed fibroids was incorrect. The real number was much higher – a dramatic 1 in 350 women could develop uterine cancer after power morcellator surgery for a partial hysterectomy or fibroid removal. In response, Johnson & Johnson withdrew their power morcellator devices from the market, and many insurance companies have stopped covering the surgery.
Despite the studies, “the FDA, the medical device industry, and many gynecologists pointed to the risk of a hidden cancer as being low, only one-in-10,000,” the letter said. “How did they get it wrong for so long?”
“We typically look at such things as whether data needed would be available, whether there are any legal obstacles, whether an inspector general’s office has work under way, as well as several other factors,” said GAO spokesman Chuck Young.
Many of the latest versions of the power morcellator device have been cleared through the 510(k) approval process, in which the FDA fast-tracks approval of new medical devices when they are significantly similar to other forms of approved devices. The government agency has received a great deal of scrutiny and concerned comments about the process, which has allowed some dangerous device including the transvaginal mesh devices, to enter the marketplace before. The FDA continues to defend the process, stating that the fast-track approval allows for greater “innovation and safety.”
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