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 RiskOn 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