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Recalls of Power Morcellators

Daily, women discover from all walks of life they have an issue linked to their reproductive system. Symptoms may entail pain during sex, prolapsed uterus, discomfort in the back, and frequent and heavy periods.

These are indications of an underlying problem that is greater, often, such as tumors or cancer.

Typically, physicians, when this is the case, prescribe a procedure of a hysterectomy to rid of all, or even a portion, of the uterus, or another cancerous reproductive system, such as fallopian tubes, ovaries, cervix, et al.

In the presence of tumors (fibroids), physicians recommend the myomectomy procedure.

Physicians use morcellators to achieve any of these types of surgeries.

Since the invention of morcellators more than 20 years ago, there’s been a gain in popularity within the healthcare community.

Due to the makeup of the device, their prevalence is huge. The device entails a crane-like, skinny arm with an interior that is hollow.

This enables medical surgeons to operate with an impact that is minimal with the device upon entry, and administer surgery at a distance from the precise point of access.

The whole process is referred to as laparoscopic morcellation, and is usually preferred due to lacking invasiveness.

US Food and Drug Administration Warnings Against Morcellation

Associated with laparoscopic morcellators, however, there are key problems. The most crucial in the concerns is the actual operation.

Morcellators work by dicing up and removing the part of the body that’s affected. 

A number of studies have proven that the process may boost the risk that the cancer disease may spread.

Other concerns related are that laparoscopic morcellation can increase time to complications and surgery if multiple points become necessary.

Some years ago, the U.S. Food and Drug Administration shared similar concerns, and offered guidance to medical providers, as well as women, to understanding, with respect, the nature of hazards the morcellators posed.

Considering recalls of power morcellators, leading morcellator device manufacturers began to consider seriously the production of the devices, after numerous studies, the US Government, and major organizations all expressed concerns strongly to suggest a correlation between the spread of cancer and laparoscopic morcellation.

These prominent corporations entail Olympus, Lumenis, Richard Wolf, Blue Endo, and Ethicon. In fact, the Johnson & Johnson owned Ethicon went one step further, and suspended sales in power morcellators.

This was done while making note that it waited for the U.S. Food and Drug Administration to clarify the purpose of laparoscopic morcellation in the invasion of fibroid disease and uterine cancer. The suspension, therefore, may only be temporary.

Ethicon through Johnson & Johnson, however, took a major and voluntary step via recalls of power morcellators from hospitals across the globe.

It is not clear, yet, whether other device manufacturers will make a decision in recalls of power morcellators.

Mainly following the lead of the U.S. Food and Drug Administration, in the healthcare community, several individuals and groups have expressed concerns recently pertaining to laparoscopic morcellation use in myomectomies and hysterectomies.

Contact us for a free consultation or call Anzalone Law Firm PLLC, at: 603.548.3797.

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