Johnson & Johnson Does Right Thing with Uterine Surgical Tools?

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The medical device manufacturer, Johnson & Johnson, is earning praise for its recent decision to withdraw a potentially dangerous surgical tool from the market that is used in a controversial process for removing uterine fibroids.

As the Wall Street Journal reported, Johnson & Johnson’s Ethicon unit announced July 30 that it would conduct a “worldwide market withdrawal” of the devices, which are called laparoscopic power morcellators.

The devices are used to remove fibroids, or non-cancerous growths within the uterus, by cutting the tissue into tiny pieces. Those pieces are then removed through tiny incisions. The minimally invasive surgical technique is used as an alternative to traditional hysterectomy procedure because it may reduce a woman’s risk of infection and require less recovery time.

However, cancerous growths, or sarcomas, can “masquerade” as fibroids, the Wall Street Journal reports. As a result, the use of power morcellators could actually facilitate the spread of cancer through a woman’s pelvis and abdomen under such circumstances.

Johnson & Johnson had actually stopped sales of its power morcellators in April after the U.S. Food and Drug Administration (FDA) urged doctors to stop using the devices due to this possible cancer-related risk.

The manufacturer’s decision to completely remove the devices from the market – even without any further FDA action to date – has been hailed as a progressive safety measure, especially coming from a company that has come under fire in recent years for failing to act faster with other medical devices, the New York Times reports.

“[Johnson & Johnson] has had a rather abysmal track record on the public health front of ethical breaches in the last few years, so this is good that they’re doing this,” the president of the National Center for Health Research advocacy group told the Times.

Johnson & Johnson’s Recent Problems

Johnson & Johnson has faced a flood of litigation in recent years due to several medical devices, including metal-on-metal hip implants and transvaginal mesh devices.

In August 2010, Johnson & Johnson’s DePuy Orthopaedics unit voluntarily recalled its all-metal ASR XL Acetabular hip and ASR hip resurfacing systems due to their high failure rates. As the Times reported last fall, internal company documents from 2011 indicated that the company knew that the metal-on-metal hip implants could fail in about 40 percent of patients within five years after they received the implant. The company is in the process of paying billions of compensation to recipients of the implants, the Times reports.

In June 2012, after thousands of lawsuits had been filed, the company’s Ethicon unit halted sales of its Gynecare line of transvaginal mesh devices. The move came after the FDA had received numerous reports that the devices – used to treat women with pelvic organ prolapse and stress urinary incontinence – had caused pain, bleeding and other serious injuries, the Times reports.

In light of those events, Johnson & Johnson’s July 30 move to voluntarily withdraw its Gynecare Morecellex, X-Tract and Morcellex Sigma devices has been seen by many as a positive, responsible decision, and one which many hope is evidence of the firm’s adoption of a more proactive, “safety-first” philosophy.

Power Morcellator Cancer Risks Merit Investigation

It should be noted that the jury is still out, so to speak, about these devices. As the Washington Post recently reported, some in the medical community believe that the risks of spreading cancer related to these devices outweigh any benefits, while others insist the opposite. It will be important for the medical community to further study this issue.

Investigation is also needed to find out what power morcellator manufacturers know about the safety of using these devices from their development of this technology. Ultimately, it may be up to consumer rights advocates in the legal community to discover this information.

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