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Morcellation Media Monitoring 4/30/2015
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Storz Morcellator Lawsuit Alleges Wrongful Death of South Carolina Woman
Apr 27, 2015 | Injury Lawyer News
By Stephanie Reid
On April 10, 2015, the grieving son of a recent victim of uterine cancer filed a personal injury and wrongful death action against several defendants, alleging excessively unreasonable misconduct and the failure to properly warn the victim of the dangers of morcellation. The lawsuit, which was filed in United States District Court for the District of South Carolina, names Karl Storz Endoscopy-America, Inc., Karl Storz Endovision, Inc., and Karl Storz GMBH & Co. KG as defendants in the matter. -
FDA Looks to Downclassify Some PMA Devices
Apr 28, 2015 | Medical Device and Diagnostics Industry
By Marie Thibault
On April 23, Senators Richard Burr (R–NC), Michael Bennet (D–CO), and Orrin Hatch (R–UT) introduced the Advancing Breakthrough Devices for Patients Act to create a priority review process for cutting-edge medical devices. Industry group AdvaMed praised the legislation, but patient activist and physician Hooman Noorchashm MD, PhD, who has campaigned to ban electric morcellators and is also advocating for CDRH reform blasted the bill. In an April 28 e-mail to legislators and journalists, Noorchashm called the bill "a serious danger to patient safety in the United States and abroad." He continued, "it is simply unacceptable for the United States Congress to be 'streamlining industry' any further when patient safety stands demonstrably compromised in the United States." -
Top 5 lessons learned at SGO's Women's Cancer Annual Meeting
Apr 27, 2015 | Healio
4. Morcellation and tissue fragmentation should be used with caution in malignant uterine tumors. Abu-Rustum said several presentations were made about the use of tissue fragmentation and morcellation in patients with uterine cancer. “Over this past year, there’s been a huge push to be very careful with the use of morcellation and tissue fragmentation,” he said. “The message was that physicians need to very careful when using this on malignant tumors of the uterus to avoid spillage of the tumor, which may potentially increase the risk of these cancers recurring, and potentially worsening the outcome of these patients.”’ -
Pennsylvania Couple Files Morcellation Cancer Lawsuit
Apr 29, 2015 | Top Class Actions
By Paul Tassin
A couple from Pennsylvania has filed a morcellation cancer lawsuit against manufacturer Ethicon and its parent company Johnson & Johnson, alleging one of the morcellator caused cancer to spread.
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Storz Morcellator Lawsuit Alleges Wrongful Death of South Carolina Woman
Apr 27, 2015 | Injury Lawyer News
By Stephanie Reid
On April 10, 2015, the grieving son of a recent victim of uterine cancer filed a personal injury and wrongful death action against several defendants, alleging excessively unreasonable misconduct and the failure to properly warn the victim of the dangers of morcellation. The lawsuit, which was filed in United States District Court for the District of South Carolina, names Karl Storz Endoscopy-America, Inc., Karl Storz Endovision, Inc., and Karl Storz GMBH & Co. KG as defendants in the matter.
The plaintiff is seeking compensation for the medical expenses, lost wages, and conscious pain and suffering experienced by the victim prior to her death, which occurred just one year following her exposure to morcellation.Background of allegations against Storz, et al.
Filing on behalf of his late mother, the plaintiff alleges a series of factual assertions pointing to the Storz Morcellator as the proximate cause of the victim’s premature death. In May, 2011, the decedent underwent a surgical procedure to remove suspicious fibroid tissue that was forming on her uterus and broad ligament. The surgeon performed two removal techniques, known as a supra-cervicalhysterectomy and a bilateral salpingo-oophorectomy, utilizing the Storz Morcellator during both procedures.
A power morcellator is a medical device used in minimally-invasive procedures wherein a surgeon opts to cut apart reproductive tissue prior to its removal through a laparoscopic incision. During this process, the morcellator is alleged to cause the dissemination of microscopic bits of biological debris into other areas of the abdomen. For surgical patients with undiagnosed uterine cancer, this toxic debris can lead to the rapid spread of dangerous cancer cells into other organ systems.
In this case, the plaintiff alleges that the surgeon’s use of the Storz Morcellator caused cancerous tissue to disseminate into his mother’s abdomen, leading to a diagnosis of adenosarcoma and sarcomatous overgrowth just six days after her uterine fibroid surgery. Tragically, despite valiant efforts to fight her condition through radiation treatments, the victim succumbed to her cancer on April 13, 2012.Causes of action involving negligence, failure to warn
At the crux of his complaint, the plaintiff alleges that the manufacturer of the Storz Morcellator was under a strict duty to warn patients and practitioners of the dangers of power morcellation when treating uterine fibroids – which it failed to do. In addition, the plaintiff asserts that, but for the surgeon’s use of the Storz Morcellator, the decedent’s cancer would have remained “well-confined to the uterus, ovaries and fallopian tubes,” and would not have spread throughout her body as it did.
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FDA Looks to Downclassify Some PMA Devices
Apr 28, 2015 | Medical Device and Diagnostics Industry
By Marie Thibault
Since February 2014, CDRH has been reviewing PMAs that were approved prior to 2010 as part of its priority to "Strike the Right Balance Between Premarket and Postmarket Data Collection." As a result, some of these products have been determined to be candidated for reclassification to Class II, instead of their current, more stringent Class III classification.
By the end of 2014, CDRH had reviewed 69% of the product codes for actively-market PMA products and hascategorized each of these codes into one of four lists:Devices that are candidates for Class II reclassificationDevices that are candidates for a shift to postmarket controls or postmarket data collectionDevices that experience a reduction or shift in data collection and/or reclassification in 2014, during the reviewDevices that should remain Class III with no changes in data collection
The list of devices considered candidates for Class II reclassification is 21 items long, including product codes for artificial saliva, bone growth stimulator, single-use female condom, and a medical image analyzer. There are also 21 devices on the list of those that could be candidates for a shift to postmarket controls or postmarket data collection. These include toric intraocular lens, an inflatable penis prosthesis, and a percutaneous cardiac ablation catheter for the treatment of atrial flutter.
Three device product codes already underwent a reduction or shift in data collection or reclassification in 2014, including a stair climbing wheelchair, an endovascular graft system for treatment of aortic aneurysm, and a nucleic acid amplification system for detection of mycobacterium tuberculosis complex.
Most of the reviewed devices will remain Class III, including pacemaker pulse-generators and electrodes, replacement heart valves, cochlear implants, carotid stents, and many more.
On April 23, Senators Richard Burr (R–NC), Michael Bennet (D–CO), and Orrin Hatch (R–UT) introduced the Advancing Breakthrough Devices for Patients Act to create a priority review process for cutting-edge medical devices. Industry group AdvaMed praised the legislation, but patient activist and physician Hooman Noorchashm MD, PhD, who has campaigned to ban electric morcellators and is also advocating for CDRH reform blasted the bill. In an April 28 e-mail to legislators and journalists, Noorchashm called the bill "a serious danger to patient safety in the United States and abroad." He continued, "it is simply unacceptable for the United States Congress to be 'streamlining industry' any further when patient safety stands demonstrably compromised in the United States."
CDRH has been focused on shortening device approval timelines with initiatives like the recently-commenced Expedited Access Pathway Program for innovative devices addressing severe diseases. At an April 28 Senate Committee on Health, Education, Labor, and Pensions hearing on America's medical innovation, Jeffrey Shuren MD, JD, director of CDRH, pointed out that device approval times have gotten shorter in recent years. He said that since 2010, the approval time for 510(k) submissions have been cut by 10% with a 30% reduction in pending applications, while PMA approval times have been cut by 26% with a 43% reduction in pending applications. As for de novoapplications, Shuren said the agency has taken two years off the review process timeline for those submissions.
Despite faster approvals, Shuren admitted that CDRH has been struggling with high turnover and difficulty competing against industry for top talent because of factors like a heavy workload and lower pay.
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Top 5 lessons learned at SGO's Women's Cancer Annual Meeting
Apr 27, 2015 | Healio
Surgical and medical approaches to ovarian cancer, sentinel node mapping for endometrial cancer, the use of tissue morcellation for uterine tissue extraction, and the 9-Valent HPV vaccine were among the key topics presented at the 2015 Society of Gynecologic Oncology’s Women’s Cancer Annual Meeting.
“We heard presentations from various speakers on topics that have generated great excitement,” Nadeem R. Abu-Rustum, MD, meeting program committee chair, told HemOnc Today. “We heard some encouraging findings, and some interesting debates.
The following are the top five lessons learned from the 2015 Society of Gynecologic Oncology’s (SGO) Women’s Cancer Annual Meeting.1. The use of standard chemotherapy plus bevacizumab confers a survival benefit in patients with ovarian cancer.
At the 2015 meeting, Robert L. Coleman, MD, of the University of Texas MD Anderson Cancer Center presented preliminary findings from a phase 3 randomized study conducted by the Gynecologic Oncology Group. In the study, women were randomized to receive either a standard chemotherapy regimen of paclitaxel and carboplatin (n = 374) or this standard regimen plus bevacizumab (n = 374). The study found that the addition of bevacizumab increased survival by a median of 5 months.
“This was one of those highly-anticipated studies that has been in design for a while, and learning the findings was a highlight of the meeting,” Abu-Rustum said.2. Laparoscopy may be a valid approach to determining the resectability of advanced ovarian cancer.
Abu-Rustum said another key topic discussed at the meeting was the use of laparoscopy to assess the resectability of advanced ovarian cancer.
“When women present with advanced ovarian cancer, we have to determine who is a good candidate to have surgery,” Abu-Rustum said. “Traditionally, we’ve used a lot of imaging and block tests, but now, more and more, the role of laparoscopy has evolved.”3. Sentinel node mapping has emerged as an important approach to surgical staging in endometrial cancer.
The topic of sentinel node mapping for the staging of endometrial cancer was one that generated a great deal of excitement at the 2015 meeting, Abu-Rustum said. This emerging approach to staging endometrial cancer was featured in six plenary sessions, and was the topic of data presented by multiple institutions, including Sloan-Kettering, MD Anderson Cancer Center, Johns Hopkins, and more. Sentinel node mapping was also the focus of a pro/con debate, Abu-Rustum said.
“What we’re finding now is that with a simple technique of injecting dye into the cervix at the time of the hysterectomy, you can map sentinel nodes in approximately 80% or more of patients and follow a specific algorithm during surgery,” he said. “This helps detect the majority of nodular disease and make the operation more precise and much more individualized; it gives you the information to help decide if the patient is high risk, and may avoid the side effects of extensive lymphadenectomy.”4. Morcellation and tissue fragmentation should be used with caution in malignant uterine tumors.
Abu-Rustum said several presentations were made about the use of tissue fragmentation and morcellation in patients with uterine cancer.
“Over this past year, there’s been a huge push to be very careful with the use of morcellation and tissue fragmentation,” he said. “The message was that physicians need to very careful when using this on malignant tumors of the uterus to avoid spillage of the tumor, which may potentially increase the risk of these cancers recurring, and potentially worsening the outcome of these patients.”’5. HPV vaccination and cervical cancer screening are crucial.
Abu-Rustum said the importance of cervical cancer screening and the HPV vaccine was addressed in the meeting’s Seminal Abstract Session. This topic is particularly relevant given recent findings on the high proportions of women not screened for cervical cancer or vaccinated against HPV.
“The seminal abstracts discussed issues relating to the importance of HPV-9, the 9-valent vaccine, as well as the importance of cervical cancer screening,” he said. “They also addressed uterine transplantation, which is a rare procedure but a very interesting development.” -
Pennsylvania Couple Files Morcellation Cancer Lawsuit
Apr 29, 2015 | Top Class Actions
By Paul Tassin
A couple from Pennsylvania has filed a morcellation cancer lawsuit against manufacturer Ethicon and its parent company Johnson & Johnson, alleging one of the morcellator caused cancer to spread.
Plaintiff Jennifer S. explains in themorcellation cancer lawsuit, filed with her husband Randall S., that she underwent a total laparoscopic hysterectomy in December 2012 for the removal of uterine fibroids. In the course of the surgery, the surgeon used a Gynecare Tissue Morcellator manufactured by the defendants. Prior to surgery, she showed no evidence of cancer, but in January 2014 a visit to the emergency room revealed a pelvic mass.
The mass was surgically resected, and she was diagnosed with metastatic serous carcinoma. She subsequently underwent six rounds of chemotherapy.
Jennifer alleges in her morcellation cancer lawsuit that prior to the surgery, she received no warning as to the risks of spreading unknown, or occult, cancer cells during the use of the power morcellator. She alleges that the power morcellator disseminated her occult cancerous tissue, causing the later malignancy.Power Morcellators and Uterine Surgery
A power morcellator is a surgical instrument used to cut a larger mass of tissue into smaller pieces that can be more easily removed from the body. Morcellation is useful in laparoscopic surgery, where the small incisions might not permit removal of larger masses of tissue.
For a hysterectomy or removal of uterine fibroids (known as myomectomy), laparoscopic surgery can be preferable to traditional surgery because it generally requires a shorter postoperative recovery time and less risk of infection.
In April 2014, the FDA issued a safety communication warning that power morcellation during gynecological laparoscopic surgery may inadvertently spread unsuspected cancerous tissue, particularly uterine sarcoma and leiomyosarcoma, beyond the uterus. Once that type of cancer spreads, the survival rate is poor. The FDA estimates about one-in-350 women who undergo a hysterectomy or a myomectomy has an unsuspected uterine sarcoma.
Based on that risk, the FDA now discourages the use of power morcellators for extraction of the uterus or uterine fibroids. The federal agency notes the existence of many alternatives to power morcellation, including traditional vaginal or abdominal surgery, laparoscopic surgery without morcellation, laparotomy with a smaller incision, deliberate blocking of the uterine artery, ultrasound, and drug therapy.
However, some of these alternatives come with longer recovery time and slightly more pain than laparoscopic morcellation. The FDA plans to add a boxed warning to the device’s labeling.
In response to the FDA warning, manufacturer Johnson & Johnson withdrew its power morcellators from the market in August 2014. Other manufacturers continue to make their own versions of the device.
HCA Holdings, the parent company of hundreds of hospitals in the United States and England, has banned the use of power morcellators in its hospitals. Other healthcare organizations have imposed similar moratoria on power morcellators. Some surgeons continue to perform the procedure in younger patients, using special bags designed to contain the tissue and prevent the spread of cancerous cells.Morcellation Cancer Lawsuits
So far Johnson & Johnson has faced only a few morcellation cancer lawsuits over its power morcellators. One morcellation cancer attorney estimates the company will face as many as 5,000 such power morcellator lawsuits.
Jennifer and her husband Randall allege the power morcellator used in her laparoscopic surgery was defective in design. They assert the defendants knew or should have known of the risk of spreading cancerous tissue during morcellation but did not properly address that risk. They claim the defendants failed to properly warn her or her doctor about the risks associated with morcellation.
The Morcellation Cancer Lawsuit is Case no. 1:15-cv-00782-SHR, in the U.S. District Court for the Eastern District of Pennsylvania.
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