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Making Things Safer: FDA’s Handling of Morcellator’s Demonstrates Role in Improving Public Safety

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The use of power morcellators in minimally invasive surgical procedures was extremely popular until the FDA issued a warning due to compelling evidence that they can spread cancer during the removal of fibroids and hysterectomies. One of the benefits of increasingly popular minimally invasive procedures is that patients undergo shorter recovery times, but they are often misled in regards to the level of risk involved. While such surgeries are marketed as low risk, they can actually carry the same risks as traditional procedures, if not more serious ones. Oversight by the FDA is instrHair Removal Laser Safe wordcloud umental in protecting the public when device manufacturers fail to properly disclose these risks.

Hidden Cancer Risk Compounded Through Morcellator Use

 The FDA issued a warning in 2014 that power morcellators could disseminate cancer cells during abdominal and uterine procedures and that this risk was compounded by the fact that a significant portion of the population have undetected cancer. Early detection of cervical and uterine cancer is instrumental in providing a positive prognosis, which is why the spread of cancer cells throughout the pelvic organs is so perilous.

Following the release of the FDA’s warning, the number of procedures requiring morcellation fell significantly. In 2013, about 14% of hysterectomies were performed with morcellators and this dropped to just 3% the following year as concerns over the links to advanced stage cancers became widely known. Numerous lawsuits followed the FDA’s announcement and it eventually led to the removal of all of Johnson & Johnson’s morcellators from the market.

Doctors Dispute FDA Warning on Grounds of Benefits Outweighing Alleged Risks

There has been some disagreement by some in the medical community over whether the risks associated with morcellation are outweighed by the potential for decreased recovery times and reduced chances of complications. Doctors in support of the procedures claim that the risks can be mitigated through more stringent cancer screenings prior to performing the procedures. By ruling out the presence of cancer, the doctors can assure that women who qualify for the operations are able to receive all of the benefits with little to no risk.

The problem lies in the fact that studies revealed the doctors using power morcellators had the same success rate in detecting the presence of cancer as their counterparts.

FDA Oversight is Instrumental in Protecting the Public

 Women should be allowed to make educated choices regarding their own care and the issue at hand is that Johnson & Johnson pushed all of the benefits without warning of the most serious risks. Power morcellator use had been approved since the 1990s, but it required an FDA warning for the public to receive all of the facts. Now that the morcellators linked to the upstaging of cancer have been removed from the market, women are able to select safer surgical options that will not place their lives at risk.

The drastic reduction in the number of uterine procedures requiring power morcellation only highlights the need for more FDA oversight. In reality, however, the FDA is severely limited in its ability to protect the public because of the loopholes available for pharmaceuticals and device manufacturers to push their products to market without knowing whether they are truly safe. The vast number of new medications and products that have been approved also make it much harder for an agency with severely limited resources to keep up with the number of complaints and adverse effects that patients experience.

Sometimes the benefits of a drug or procedure really can outweigh the risks, but we have the right to know what those risks are so that we decide whether to take them.

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The Drug Law Center is sponsored by lawyers who represent individuals and families who have suffered a serious injury or death from a dangerous drug or medical device. While these medical inventions have been marketed to improve the quality of life for people, unsafe drugs and poorly designed medical devices can drastically reduce the quality of life for the individual and his or her family.

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