Has there been an fda recall for power morcellators. Plaintiffs allege they were never warned that morcellators can seed undiagnosed leiomyosarcoma in uterine fibroids, leading to the spread of cancer. Laparoscopic hysterectomy with manual morcellation of the. Just one year ago, capital blue cross used their website to announce that they had witnessed what seemed to be a significant patient safety concern connected to power morcellator use and, from november of 2014 on, discontinued all reimbursements for procedures involving the device. Moresolution tissue morcellator power morcellators cleared without clinical testing through the fdas 510k route the fdas primary concern as we consider the continued use of these devices is the safety and wellbeing of patients, said william maisel, deputy director for science and chief scientist at the fdas center. Myomectomy fibroids can trigger morcellator lawsuit myomectomy is the surgical removal of fibroids from the uterus. Power morcellator lawsuit morcellator lawsuit filings have begun to mount in u. The karl storz product portfolio includes loops for resection, incision, enbloc resection as well as vaporization and enucleation electrodes for the prostate, bladder and urethra. Morcellator with its simple and intuitive operation panel controls the speeds of the attached instruments. Karl storz provides a modern, adaptive morcellator system for enucleation that enables fast and efficient morcellation or the removal of prostate tissue from the.
Several women who have undergone morcellator surgery have experienced medical complications. Minimally invasive tissue extraction made simple with. Women who have been diagnosed with cancer after getting laparoscopic hysterectomies may be eligible to join the cancer lawsuits. A unique solution that improves patient outcomes by offering women all of the. The morcellator moresolution offers a very controlled extraction of tissue with a slow turning cutting blade.
This means a tumor may go from stage 1 to 4 after morcellation, which makes the cancer difficult to treat and decreases the chances of longterm survival. These devices are used to cut up the unwanted tissue so that they are in pieces that are smaller and therefore much easier for the surgeon to remove. The use of laparoscopic power morcellators during fibroid surgery may spread cancer, and decrease the longterm survival of. The 15mm morcellator is then placed at the umbilicus. A 38yearold patient wanted definitive treatment for menorrhagia. Fbi investigating morcellator device that spread uterine. In the video above, youll notice the introduction of dr. Instructions for use for the blue endo moresolution electromechanical laparoscopic morcellator system, model 55000011, consisting of the control unit, handgrip, flexible shaft, trocarsobturators, sleeves, valves, and blades. Traditional intracorporeal tissue extraction techniques use power morcellation without specimen containment.
Morcellators cut up the uterus to make it easier to remove, but they can also spread malignant cells and worsen undiagnosed cancer. Power morcellators may increase risks parker waichman llp. Morcellator lawsuit dozens of lawsuits have been filed by women who developed cancer after doctors used a morcellator during their hysterectomy. Blue endo moresolution tissue morcellator lina medical xcise cordless laparoscopic morcellator karl storz rotocut g1, g2, steiner, and sawalhell supercut morcellator. Morcellators have been linked to the spread of uterine cancer. Gynecare xtract tissue morcellator recalled blue endo. Morcellator class action lawsuit morcellator lawsuits. Uterine fibroids hysterectomy with morcellation youtube. Aug 30, 2016 power morcellator lawyer power morcellator lawsuit women planning to undergo a laparoscopic hysterectomy or other minimallyinvasive gynecological surgery that will involve the use of a power morcellator should be sure to speak with their doctors about the risks potentially associated with such procedures.
Lhh medical locates in beijing, and has won many national invention patents since its establishment. Power morcellator lawyer power morcellator lawsuit women planning to undergo a laparoscopic hysterectomy or other minimallyinvasive gynecological surgery that will involve the use of a power morcellator should be sure to speak with their doctors about the risks potentially associated with such procedures. Capital blue cross announced it will no longer pay for laparoscopic hysterectomy morcellation procedures as of november 1. Power morcellator lawsuits women who had hysterectomies and fibroid removals with power morcellators filed lawsuits against manufacturers after, they claim, the devices spread uterine cancer.
Clearview uterine manipulator, sound dilator, scope warmer, lap loop, trocar, spirotome, blue heat, blue heat boost, insufflation. Essentially, they are a piece of gear that handles a great deal of the cutting. How disfavored hysterectomy device got doctor groups blessing. While companies that have sold power morcellators in the past may remove them from the marketplace at any time, here are some of the names you may want to search for in your medical records if you wish to sue. Power morcellator lawsuits allege, among other things, that manufacturers.
Morcellation may then proceed, keeping in mind that the morcellator blade must be in view at all times. Lawyers for leiomyosarcoma lms cancer following hysterectomy, uterine fibroid removal surgery. Morcellator manufacturers you may be aware of the problems relating to the use of the laparoscopic surgical devices known as power morcellators. Laparoscopy in surgery, gynecology, and urology laparoscopy, the inspection of the abdominal cavity using a rigid endoscope, has been used to assess abdominal and pelvic organs for many years. Morcellator morcellator is used to smash and suck out sofe tissue after enucleation by laser device in urology bph treatment operation. The pks plasmasord bipolar morcellator is the first completely bladeless solid organ removal device. For abdominal hysterectomy, power mocellation offers the benefit of minimally invasive surgery since many years. Morcellator lawsuit hysterectomy cancer lawyer, attorney.
Amy reed, md, phd, an anesthesiologist whose laparoscopic hysterectomy in october 20 called into question the safety of power morcellation, died wednesday, may 24, at 44 years of age from. Robotic hysterectomy with morcellation of uterine fibroids tyler kirby, md. May 27, 2015 the fbi reportedly is investigating a medical device that was withdrawn from the market last year after it was found to spread cancer in women. Morcellator class action lawsuit morcellation lawsuits. Olympus morcellator cleared based on substantial equivalence the olympus pk morcellator is designed for the very same surgeries that the fda warned against. The innovative blue endo line for minimal invasive surgery is completely made in. A morcellator is a surgical instrument used for division and removal of large masses of tissues during laparoscopic surgery. The use of laparoscopic power morcellators during fibroid surgery may. A video of the morcellation viewed from the inside and the outside may be. It uses mechanical energy, rather than electrical to chop tissue. For the morcellation of tissue speeds of up to rpm are appropriate. Recent studies show that a laparoscopic morcellator, which is a tool used to remove large amounts of tissue through a small hole may be one of these devices. These are innovative tools that can be used in robotic surgical procedures as well as manual, laparoscopic ones.
Power morcellators were developed for this purpose in the early 90s and became widely used as the popularity of laparoscopic surgeries grew. Laparoscopic procedures have the advantage of allowing patients to have small scars, recover faster, have less pain, less blood loss, less infection, and the ability to return. The fbi reportedly is investigating a medical device that was withdrawn from the market last year after it was found to spread cancer in women. Minimallyinvasive surgical concepts using power morcellation have developed over the decades and have become widespread in use for hysterectomy and myomectomy.
Myomectomy saves the uterus, and it can save a woman from undergoing a complete hysterectomy. Feb 06, 2011 laparoscopic morcellator technique explained by prof. The tool was designed to allow surgeons to perform minimally invasive surgeries even when large pieces of tissue or organs needed to be removed. It is important that the umbilical incision is not too large because this area must be airtight. Many experts believe this litigation is just the tip of the iceberg, as fda officials are discouraging laparoscopic power morcellation in gynecological. She later found out the device had distributed undiagnosed leiomyosarcoma. Advincula reports that he is a consultant to blue endo, coopersurgical, intuitive.
This device uses a pouch to surround the tissue to be removed before it is chopped into pieces. In laparoscopic hysterectomy the uterus is minced up, or morcellated, into smaller pieces inside the womans abdominal cavity in order to extract from the abdomen. While the manufacturer of the device has not been identified, the lawsuit names blue endo, ethicon, lina medical and others as defendants. The fda cited the power morcellators potential to spread uterus cancer throughout the abdomen. Welcome to the world of endoscopy karl storz endoskope. Morecellsystem the solution that enables isolation and containment of tissue in power morcellation. Morecellsafe is designed to further increase the safety of blue endos moresolution system used for power morcellation in laparoscopic. A hysteroscopic morcellator is used for hysterectomies, the removal of the uterus. The first power morcellator was approved by the fda through a process called 501k clearance, which presents a new device as safe based on supposed similarity to a device already on the market. On one hand, these devices allow for a less invasive surgery with a lower risk of infection, bleeding and scarring, in. A morcellator is a device that can be inserted into a small incision, and chop up an organ or tissue to be removed. Ethicon, lina, and blue endo have been specifically named in lawsuits surrounding injuries and deaths caused by the spread and development of uterine cancers including leiomyosarcoma, endometrial stromal sarcoma, endometrial adenocarcinoma, and carcinoma after power morcellator use. Supported by experienced technicians and proper equipments, we also provide repairs and calibration for electromedical equipment. Instruments for urological and pediatric urology as well as flexible video endoscopes complete our line of urology products.
Jennifer chambers, chief medical officer of capital blue cross said, as a leading health insurer, we are counted on to help safeguard the health of those entrusted to us, which is why we are no longer providing coverage for procedures involving power morcellator. Please be advised that the pks plasmasord labeling has recently been revised to include the below information. In light of the morcellation controversy, what is your. Our lawyers are investigating potential lawsuits for women who were diagnosed with leiomyosarcoma or other cancer following. Class 2 device recall moresolution morcellator system. The model described here is viewable in the video, the excite technique, part 2. Contained tissue extraction system olympus america medical. Power morcellator lawsuits cancer risks from surgery.
Her uterus, which was 18 weeks in size, was removed. Myomectomy fibroids can trigger morcellator lawsuit. Power morcellator lawsuit leiomyosarcoma allegations. Hooman noorchashm, were the first plaintiffs to speak out about the issues with the device reed, a mother of six, had a hysterectomy with a power morcellator in 20. Many power morcellator cases are now consolidated ethicon is a common defendant. Tissue extraction during minimally invasive gyn surgery. Amy reed, md, phd, an anesthesiologist whose laparoscopic hysterectomy in october 20 called into question the safety of power morcellation, died wednesday, may 24. On one hand, these devices allow for a less invasive surgery with a lower risk of infection, bleeding and scarring, in addition to a shorter recovery time. Jul 15, 2016 myomectomy fibroids can trigger morcellator lawsuit myomectomy is the surgical removal of fibroids from the uterus.
Uterine morcellator morcellator blue endo medicalexpo. Consumers nationwide have filed lawsuits against blue endo, ethicon inc. A device called a power morcellator allows us to cut the tissue into small pieces so they can be removed through the small incisions, therefore avoiding a large incision. Power morcellator lawsuit uterine morcellation lawsuit. Minimallyinvasive surgical concepts using power morcellation have developed over the decades and. Blue endo innovative minimally invasive surgical products. Hooman noorchashm a thoracic surgeon have become the most vocal and outspoken critics of morcellation due to the extreme risks that have now come to light. In 2017, the fda reaffirmed its 2014 guidance for laparoscopic power morcellators. The officers and council of the british society for gynaecological endoscopy bsge have decided to issue this additional statement in light of ongoing debate on power morcellation during laparoscopic myomectomy and hysterectomy procedures. Power morcellator uterine morcellation in hysterectomy. Power morcellator recalls a power morcellator is a surgical device used to remove tissue from the body through a small, laparoscopic incision.
When used to remove fibroid tumors, the morcellator could potentially spread small pieces of tissue that may be cancerous in rare circumstances. Fda approves new power morcellator despite cancer risks. The product liability claim is the first federal morcellation cancer lawsuit involving a manufacturer of uterine morcellators and names ethicon, blue endo, and lina medical as defendants. Morcellator lawsuit morcellation cancer lawyer dc, md, va. Endo is a company that fulfills legal requirements and receives approval from companys legal entity of indonesia, with number c05336 ht.
Morcellator lawsuit consultations for cancer victims. Morcellation may then proceed, keeping in mind that the morcellator blade must be in. Mishra world laparoscopy hospital, cyber city, dlf phase ii, gurgaon, india. Another case was recently filed in new york by a woman who developed cancer after having robotassisted hysterectomy that involved the use of power morcellation. Early morcellators were handoperated, but those that have been in use since the early 1990s are electric. Endo indonesia was founded in 2006 as a company engaged in importation and distribution of medical. Morcellator general information a morcellator is a device used during surgeries to remove larger clusters of tissue from the body with ease. Advincula reports being a consultant to blue endo, coopersurgical. Endoscopes, instruments, devices, and camera systems from karl storz have stood for tradition, advanced technology, and quality for more than 70 years.
Tissue morcellation performed in combination with an isolation containment bag is one of the most important advancements in laparoscopic surgery. Morcellation for testes extraction in horses undergoing standing. The procedure is laparoscopic power morcellation and the product is a power morcellator. But whether the pk morcellator poses equivalent cancerspreading risk is difficult to determine, because the device did not undergo human testing. Aagls conflictofinterest policy played into the may 2014 report. Our lawyers are investigating potential lawsuits for women who were diagnosed with leiomyosarcoma or other cancer following surgery which involved the use of a power morcellator.
Power morcellators are medical devices used in laparoscopic hysterectomies or myomectomies, which let surgeons cut up uterine fibroids through a small incision. A morcellator is a surgical instrument used for the division and removal of large masses during laparoscopic surgeries. Many advocates see morcellator lawsuits as a way to bring awareness to the danger of power morcellators. With autozero blades and back flush cannulas function, that realizes high operation safety and auto clearout. It is estimated that 600,000 hysterectomies are performed in the u. Furthermore, the 3d video endoscopes from karl storz. She later found out the device had distributed undiagnosed leiomyosarcoma throughout her. Amy reed, the anesthesiologist who found out she had stage 4 leiomyosarcoma after coming out of her myomectomy surgery for fibroid removal. Since 20, numerous morcellator cancer lawsuits have been filed against ethicon inc. Endoloop ligature, with roeder knot, for bleeding stumps, with absorbable synthetic suture. The first lawsuit was scheduled for trial november 3, 2015, before the parties reached a settlement agreement for an undisclosed amount. Jennifer chambers, chief medical officer of capital blue cross said.
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