Power Morcellator Lawsuits
On November 24, 2014, the U.S. Food and Drug Administration (FDA) updated a warning issued in April regarding power morcellators and the risk for spreading previously undetected cancer.
The FDA warning stated the following:
- Power morcellators should not be used in the removal of the uterus or uterine fibroids in the vast majority of women.
- The FDA recommends that power morcellator devices contain boxed warnings on labels stating that the device may spread undetected cancer during fibroid surgery.
- In rare cases when a power morcellator is recommended by a physician for removal of uterine fibroids, the FDA recommends that physicians must fully advise patients of the risks involved.
The Law Offices of Peter Angelos, P.C. is investigating cases of women who have been diagnosed with cancer following an OB-GYN doctor's use of a power morcellator to remove uterine fibroids.
Power Morcellators Spreading Undetected Cancer
Power morcellators are surgical devices with rotating blades that grind uterine fibroids into small fragments for removal through small incisions in the abdomen. Unfortunately, there are no reliable methods to pre-operatively determine whether a fibroid contains a hidden uterine cancer. The inability to definitively rule out cancer prior to using the morcellator makes the laparoscopic supracervical hysterectomy using a power morcellator, a high risk procedure. If a fibroid contains cancer cells, including a deadly type known as leiomyosarcoma, cutting the fibroid or uterus with the morcellator could cause the cancer to upstage by spreading cancerous cells throughout a woman's abdomen and pelvic area.
The safer alternative is a classic hysterectomy, which removes the uterus and fibroids intact. There is no middle ground. Power morcellators should have never been manufactured, approved or used by surgeons because this medical device endangers the lives of women.
In 2013, Dr. Amy Reed experienced first-hand the drastic consequences of the power morcellator device. Following her uterine fibroid removal by power morcellation, Dr. Reed was diagnosed with cancer. Since this time, she and her husband, Dr. Hooman Noorchashm, have been outspoken about the dangers presented by morcellation. Recently, Drs. Reed and Noorchashm have spoken with the FBI about their concerns that Johnson and Johnson had knowledge of the dangers presented by the devices.
UPDATE: The FBI has launched an investigation addressing the specific concerns pertaining to the loss of life, which occurred in part, as a result of Johnson & Johnson’s negligence.
Johnson & Johnson was Alerted to Risks of Power Morcellator in 2006
The Pittsburgh Business Times reported on May 30, 2014, that eight years ago, in 2006, a pathologist communicated with a Johnson & Johnson subsidiary urging the company "to reconsider the risk to the patient from the use of the device-called a power morcellator". The device may spread cancer from the fibroid tissue that is being divided and removed by morcellation throughout the body. The physician told Johnson & Johnson that "[w]hen the operative procedure is a standard hysterectomy, no damage is done. If a morcellation is done, the patient's survival is jeopardized."
The FDA Alert
On April 17, 2014, the FDA issued a warning advising doctors that as many as one in 350 women who undergo a power morcellation procedure is at risk for the spread of cancer. An FDA Advisory Committee conducted hearings on July10-11, 2014, and heard testimony regarding the serious risks of power morcellation to a woman's health.
The FDA advises women who have already undergone a hysterectomy or myomectomy for fibroids and have been told that testing of the tissue removed during the power morcellation procedure was negative for the presence of cancer that they should have routine follow-up with their physicians.
Contact Experienced Attorneys at The Law Offices of Peter Angelos, P.C.
If you, a family member or a friend has been diagnosed with cancer or other serious medical complications after a power morcellator procedure for removal of uterine fibroids, you should contact The Law Offices of Peter Angelos, P.C. for additional information and a no-charge consultation with one of our experienced attorneys.
We are dedicated to fighting for the rights of the victims of dangerous products.