The USFDA is warning women that the Morcellation system could result in the spreading of cancerous cells and tissue to other regions of the body thus resulting in a increased risk of cancer. Our defective medical and surgical device law firm
is currently investigating the filing of class action and or single party lawsuits against the manufacturers of morcellation devices used in hysterectomies across the country.
FDA Warning on the Use of Morcellator Device Due to Cancer Risk
On April 17th 2014 the Food and Drug Administration issued an advisory warning against the use of Morcellator surgical devices
in hysterectomy operations. According to the warning letter the use of the surgical device has been linked to a heightened risk of the development of cancer amongst women undergoing the procedure. The medical device safety communication states, “If laparoscopic power morcellation is performed in women with unsuspected uterine sarcoma, there is a risk that the procedure will spread the cancerous tissue within the abdomen and pelvis, significantly worsening the patient’s likelihood of long-term survival.”
Generally hysterectomies are preformed to eliminate symptoms associated with fibrosis a condition that can result in severe cases of pain, discomfort, bladder and bowl irregularities and chronic vaginal bleeding. The morcelattion system was developed to be a less invasive way of removing post surgical flesh from a patient uterine system via the vaginal canal. Additionally the morcellator system was to result in faster recovery time for patients.
Specific Make and Models of Laproscopic Morcellation Devices Posing a Threat to Patients:
A list of specific morcellation devices believed to pose a threat of exposing women to an increased risk of post surgical-hysterectomy cancer are provided below..
- FemRx: Diva Morcellator
- Lumenis Incorporated: VersaCut Morcellator
- Ethicon Gynecare: X-Tract System, Morcellex Tissue, Morcellator Morcellex Sigma
- Hologic: MyoSure
- Nouvag: Morcellator TCM3000BL
- Interlace Medical: Hysteroscopic Morcellator
- Smith & Nephew: Trueclear Hysteroscopic Morcellator
- Olympus: Gyrus PKS PlasmaSORD
- Blue Endo – MOREsolution Tissue Morcellator
- LiNA Medical – Xcise Cordless Laparoscopic Morcellator
- Karl Storz – Rotocut G1, G2, Steiner, and Sawalhell Supercut Morcellator
- Morce-Power: 2306 Electronic Morcellator
Filing a Defective or Unsafe Medical Device Lawsuit – And Class Action Claim
Generally, there are three ways to prove the existence of a defect in a medical device. (1) Defect in the original design of the product. (2) Defect in the manufacturing process of the device. (3) Defect in the labeling – also known as the failure to properly warn of all known and or knowable defects associated with the use of the medical device. According to the FDA morcellation devices are used in tens of thousands of procedures every year prompting calls for the implementation of a class action – mass tort lawsuit. However in some instances single party claims are more beneficial to victims then mass tort class action lawsuits. This is because in class action lawsuits every individual member has a right to an equal portion of the settlement amount provided regardless of the severity of magnitude of the ham suffered. Thus victims who are more severely harmed will not be able to receive the full and just compensation they would have attained vial the filing of a single party defective product claim.
Attorney Consultation for Morcellation Cancer Lawsuits – Cost of Legal Representation
All confidential legal consultations are conducted by our attorneys free of charge for any harmed individual who contacts our law offices. In many instances victims of harmful medical devices maybe hesitant to seek out legal representation for fear of costs associated with pursuing legal actions against at fault and liable parties. In response our legal system allows for legal representation on a contingency fee basis. This means that any legal fee or cost associated with representation will only be taken out of a financially successful settlement or jury verdict. There are no upfront or out of pocket legal fees associated to any legal work that is completed. No Win Zero Fee Guarantee
– If there is no successful settlement or jury verdict you will not have to pay us anything.
If you have any further questions feel free to contact our attorneys by calling (855)385-2529.
Laparoscopic Device Surgery Injury Attorney
Statute of Limitations for Filing a Defective Product Lawsuit