Currently, doctors are not required to report adverse events or potential defects associated with medical devices used during surgical procedures, such as power morcellation to the FDA.
This may soon change, though, as a new bill aims to prevent life-threatening power morcellation side effects, such as the potential to cause theย spreadย of cancer cellsย during gynecologic surgeries.
Inspired by one womanโs experience with power morcellation spreading undiagnosed uterine cancer, Rep. Mike Fitzpatrick and other lawmakers have introduced a bill mandating doctors to report serious complications with medical devices like the power morcellator to the FDA.
In 2013, Dr. Amy R. and her husband embarked on a campaign to educate both the medical community and the public about a little-discussed but potentially life-threatening issue: the spread of undiagnosed uterine cancer through the use of a power morcellation during laparoscopic gynecologic surgery.
When Dr. Amy learned that leiomyosarcoma she didnโt know she had was spread throughout her abdomen after a power morcellator was used during her hysterectomy, she and her husband began to investigate the issue.
After learning thatย up to one in 350 women may have undiagnosed uterine cancer spread through power morcellation,ย she began a public crusade to save other women from morcellation cancer.
It was Dr. Amyโs story and activism that prompted Reps. Mike Fitzpatrick (R. Pa.) and Louise Slaughter (D., N.Y.) to draft theย โMedical Device Guardianโs Actโย and present it to Congress.
โNot one person had reported this deadly effect to the FDAโ until [Amy], a mother of six, experienced it herself, said Rep. Mike Fitzpatrick, โIt should not have been falling to the patients to bring this to the FDAโs attention,โ Fitzpatrick said.
Power Morcellation Risks
Surgeons may use power morcellation when performing laparoscopic hysterectomies or myomectomies. Myomectomy refers to the removal of uterine fibroids and hysterectomy refers to the removal of the uterus, and possibly other reproductive organs such as the fallopian tubes, ovaries, and cervix.
When surgeons use a minimally invasive approach to perform these surgeries, the structures must be rendered into small pieces before the surgeons can remove them from the patient. Power morcellation accomplishes this.
However, in breaking up bodily structures, power morcellation also has the potential to spread undetected uterine cancer cells well beyond their point of origin, effectivelyย turning a stage one diagnosis into a stage four diagnosis.
This is a matter of concern because some women undergoingย hysterectomies and myomectomiesย are unaware that they have cancer before having these surgeries.
Under this proposed new law, doctors and their offices would be added to the list of mandated FDA reporters for any issues noted with medical devices. They would also be protected from civil lawsuits regarding any of their reports to the FDA.
It is hoped that this new law will help to spread awareness of potential risks or defects associated with medical devices such as morcellation cancer much more quickly, possibly preventing future adverse events.
Power Morcellation Cancer Lawsuits
Someย lawsuits alleging uterine cancer afterย morcellationย have been filed,ย claiming that the manufacturers should be held liable.ย The FDA issued a black box warning for these devices after reports of morcellator risksย arose.
Johnson & Johnson pulled its power morcellators from the market. Although other brands are still available, many hospitals have restricted or eliminated their use.
If the bill is signed into law, itย would facilitate preciseย tracking of many other high-risk medical devices, in addition to power morcellators.
While this new law could certainly reduce future damage done by faulty or defective power morcellation devices, it does not diminish the suffering of the women and families who have already suffered as a result of cancer spread by power morcellation.
Do YOU have a legal claim? Fill out the form on this page now for a free, immediate, and confidential case evaluation. The morcellation cancer attorneys who work with Top Class Actions will contact you if you qualify to let you know if an individual lawsuit or class action lawsuit is best for you. [In general, morcellator cancer lawsuits are filed individually by each plaintiff and are not class actions.] Hurry โ statutes of limitations may apply.
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If you or a loved one were diagnosed with cancer in the uterus, pelvis or abdomen within two years of undergoing surgery for a myomectomy (removal of fibroids), hysterectomy (removal of the uterus), oophorectomy (removal of the ovaries), or salpingectomy (removal of fallopian tubes), you may have a legal claim. See if you qualify by filling out the short form below.
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