Texas IVC Filter Lawsuit Filed

A Texas man hasCook IVC Filter Attorney filed an IVC Filter Lawsuit in Houston’s Harris County courthouse.  The man has filed a case naming the implanting doctor and Cook Incorporated, a/k/a Cook Medical, LLC.

State Jurisdiction

Cook Medical is headquartered in Indiana, but the implanting doctor practices in Texas; so the plaintiff has exercised his right to demand a jury trial in Harris County. The plaintiff’s claims in the action were also brought solely under state law. The petition states that the “Plaintiff does not herein bring, assert, or allege, either expressly or impliedly, any causes of action arising under any federal law, statute, regulation, or provision.  Thus,” it argues, “there is no federal jurisdiction in this action on the basis of a federal question under 28 U.S.C. section 1331.”

The plaintiff was surgically implanted with an IVC filter in 2015, by Dr. Adrian A. Wong, a specialist in Interventional Radiology. Dr. Wong implanted a Cook Celect Inferior Vena Cava Filter in the plaintiff.

Failed Removal Attempts
Seven weeks later, on or about April 23, 2015, surgeons attempted to remove the Celect IVC filter but were unable to remove it. According to the petition, the filter had tilted and imbedded into the wall of the plaintiff’s vena cava.  Another removal attempt was made June 2015, but was also unsuccessful. A leg or strut of the IVC filter had protruded through the man’s vena cava wall and lodged in a position adjacent to his aorta, according to the petition.

The man is now at risk for future migrations, perforations, and/or fractures from the irremovable filter, charges the petition. He also faces numerous health risks from the retained filter, including increased risk of blood clots and the risk of death. He will require ongoing medical care and monitoring for the rest of his life and may ultimately require more surgery in further attempts to remove the filter.

The Doctor’s Responsibility Alleged
The petition further alleges that the doctor knew or should have known, inter alia, that only certain patients were proper candidates for an IVC filter, and the doctor also should have known that:

  • the longer a Celect IVC remains in the body, the higher the risk of device fracture or failure
  • the Celect IVC filter is not effective to prevent clots and/or increases the risks of clots
  • safer alternatives to the Celect IVC filter existed
  • Celect filters frequently tilt, migrate, perforate, fracture, and thus involve a high increasing degree of risk to a patient implanted

Lack of Clinical Testing, Contraindications

The petition further claims Cook failed to conduct any clinical testing, such as animal studies; that Cook knew or should have known the Celect filter had a high rate of fracture, migration, and excessive tilting and perforation of the vena cava wall once implanted. It further claims that Cook knew or should have known such failures exposed patients to serious injuries that include death, hemorrhage, cardiac/pericardial tamponade, cardiac arrhythmia, and other symptoms similar to myocardial infarction – severe and persistent pain, perforations of tissue, vessels, and organs; and inability to remove the device. Cook also knew or should have known certain conditions or post-implant procedures such as morbid obesity or open abdominal procedure could affect the safety and integrity of the Celect IVC Filter.

The petition also claims Cook should have known these risks for the Celect were and are substantially higher than other similar devices. The petition also alleges that Cook failed to issue a recall of the Celect Filter and failed to notify customers that a safer device was available.

Texas IVC Filter Case Filed

The case is No. 201703885 in Harris County District Court. Defendants are Adrian A. Wong, M.D.; Cook Incorporated; a/k/a Cook Medical, (LLC).  Attorney David Matthews of Matthews & Associates Law Firm represents the plaintiff.

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Women not warned of Permanent Hair Loss – Cancer Drug

American women were taxotere-lawsuitnot warned about the increased risk of permanent hair loss that can result from the cancer drug Taxotere, while doctors and their patients in France and Europe were warned about the added risk of Alopecia several years earlier. The drug’s maker consequently faces Taxotere Lawsuits.

U.S. Women Warned a Decade Late
French drug maker Sanofi-Aventis waited until December 2015 to warn U.S. cancer patients and their doctors about the risk of permanent alopecia from the company’s cancer drug Taxotere. And even at that late date, the company added the warning only after the U.S. Food and Drug Administration ordered it to do so.

Taxotere Warnings
Sanofi-Aventis began to warn patients in Europe and Canada back in 2005 about permanent hair loss from Taxotere. U.S. doctors and their patients, meanwhile, were at least for a decade unaware that Taxotere raised the risk of permanent alopecia. Americans were also unaware of an alternative chemotherapy drug that is just as effective, and is safer and less expensive – Taxol, made by Bristol-Myers Squibb.  Taxol also comes without Taxotere’s “side effect” of permanent hair loss or complete baldness, which can hardly be called a mere side effect when it represents a permanent condition.

Sanofi-Aventis fined $109 Million in Qui Tam Lawsuit
Sanofi-Aventis’ deceitful, duplicitous marketing of Taxotere comes on the heels of criminal behavior for which the company has been held accountable in the past. Sanofi-Aventis was ordered in 2012 to pay an enormous fine stemming from criminal behavior used to hoodwink the public and boost profits.

Sanofi Agrees to Pay $109 Million Fine for False Claims, Kickbacks
The U.S. Justice Department web site stated Dec.19, 2012 that Sanofi-Aventis U.S. Inc. agreed to pay $109 million to resolve allegations that Sanofi US violated the False Claims Act. The company paid for a scheme in which it used physicians to file false reports which were used to set reimbursement rates that caused government programs to pay inflated amounts for Sanofi products.

The United States alopecia-2contended that Sanofi faced pressure from a lower-priced competitor, so the company trained its sales representatives to manipulate the market. The U.S. Justice Department said, “Sanofi US sales representatives often entered into illegal sampling arrangements with physicians, using the free units as kickbacks and promising to provide negotiated numbers of them in order to lower Hyalgan’s effective price. The government contends that there were numerous such arrangements.”

Taxol, The Safer Alternative
Taxotere Lawsuits brought by women suffering permanent hair loss will all point out that a safer, better, alternative drug was available when the victims were prescribed Taxotere by unwitting medical personnel. Taxol is derived from more natural means than Taxotere, which is twice the strength of Taxol. It is too strong, in fact, as its strength seems to be the mechanism that permanently kills hair follicles, leading to permanent baldness.

Taxotere’s Misleading Promotion 

Taxotere (docetaxel) has been vastly promoted by Sanofi-Aventis as a newer, more effective alternative to Taxol (paclitaxel).  Since its 1992 approval, the older chemotherapy drug Taxol (made by Bristol-Myers Squibb) has been one of the most widely used drugs in the adjuvant treatment of breast cancer. Taxol has been supported by high-quality evidence in the scientific literature that prove its safety and effectiveness. Comparison between the two medications proved them to be nearly equivalent; however, Sanofi kept claiming docetaxel superior to paclitaxel in early advertising campaigns. The advertising blitz apparently paid off, as Taxol use has progressively fallen in the last ten years, while Taxotere has gained substantial market share, despite its higher price.

Women not warned of Permanent Hair Loss – Cancer Drug

In April 2009, the FDA accused Sanofi of overstating the efficacy of Taxotere by giving the doctors and patients misleading promotional material that included unsubstantiated superiority claims. In its warning letter, FDA highlighted that no clinical experience ever provided substantial evidence about the fact that docetaxel was safer, better or more effective than paclitaxel. Sanofi falsely claimed that Taxotere was associated with significantly higher response rates, longer duration of response, longer median overall survival compared to its competitor, Taxol. Sanofi cited a study in support of these claims that FDA deemed insufficient, ruling that the study failed to demonstrate statistical significance and was never replicated.

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Contaminated Devices threaten Heart Surgery Patients

The Centers for sorin-3tDisease Control has acknowledged that contaminated heater-cooler devices used for open chest surgeries threaten heart surgery patients. The CDC is warning healthcare providers and patients about the potential risk of infection from  devices used for open heart surgery. The agency recommends hospitals take action, and it advises patients who suspect infection to seek care.

Infection Symptoms: Sweats, Aches, Weight Loss, Fatigue, Fever
CDC announced on Oct. 13, 2016 that people who had open heart surgery should see a doctor if they experience infection symptoms such as night sweats, muscle aches, weight loss, fatigue, fever.

Stöckert 3T heater-cooler devices
The CDC advice follows reports that some LivaNova PLC (formerly Sorin Group Deutschland GmbH) Stöckert 3T heater-cooler devices, which are used during open heart surgeries, might have been contaminated during their manufacture. That contamination could put patients at risk for life-threatening infections.

250,000 Heart Bypasses Yearly
More than 250,000 heart bypass procedures using heater-cooler devices are performed in the U.S. yearly, some 60 percent of total bypasses in the country. Heater-cooler units are used during surgery to help keep a patient’s circulating blood and organs at a specific temperature. CDC estimates that in affected hospitals, the risk of a patient getting an infection from the bacteria was between 1/100 and 1/1,000. CDC admits these infections can be severe and that some patients have died, but says it is unclear whether the infection caused death.

Valve and Prosthetics Patients at Higher Risk
The CDC has also cautioned that patients with implanted valves or prosthetics are at higher risk of these potentially deadly infections.

October 2016 CDC Health Alert Network Advisory
“It’s important for clinicians and their patients to be aware of this risk so that patients can be evaluated and treated quickly,” said Michael Bell, M.D., deputy director of CDC’s Division of Healthcare Quality Promotion. “Hospitals should check to see which type of heater-coolers are in use, ensure that they’re maintained according to the latest manufacturer instructions, and alert affected patients and the clinicians who care for them.”

CDC and the FDA initially published information and alerts about Stockert 3T heater-cooler device problems in 2015. Then in October 2016, CDC’s Morbidity and Mortality Weekly Report covered recent laboratory tests by CDC and National Jewish Health which show bacteria from 3T heater-cooler devices match bacteria found in patients in several states.

German Manufacturing Problems Revealed
Results of the latest tests add to previous evidence from Europe that suggests bacteria which contaminated these devices came from the device’s manufacturing process in Germany.

Mycobacterium chimaera Bacteria
The bacteria, Mycobacterium chimaera, is a species of nontuberculous mycobacterium (NTM) often found in soil and water. M. chimaera rarely makes healthy people sick in normal circumstances, but patients who have been exposed to it through open-heart surgery can develop general and nonspecific symptoms which can often take months to manifest. Diagnosis of these infections can consequently be missed or delayed for months or years, which adds to treatment difficulties. No test yet exists to determine whether a person has been exposed to the bacteria. Laboratory culture is needed to diagnose infections. The slow growth of the bacteria means it can take months for infection to be ruled out.

Contaminated Devices threaten Heart Surgery Patients

CDC says it will continue to work with the FDA and the clinical community to further evaluate and reduce the risk associated with these devices. The agency recommends that open-heart surgery survivors concerned with any symptoms  contact their healthcare providers.

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Surgical Heater-Cooler Infections can be Fatal

Stockert 3T sorin-3tHeater-Cooler puts ½ Million at Risk for Infections. Our law firm is handling Stockert 3T Heater-Cooler Lawsuits.

As many as a half million open heart surgery patients since 2006 could develop a potentially deadly illness due to the Stockert 3T Heater-Cooler device. The Stockert 3T uses water to maintain a patient’s body temperature during surgery. The CDC reports that the device provides an ideal breeding environment for a potentially deadly bacterium.

Non-Tuberbulous Mycobacterium
Known as mycobacterium chimaera or “non-tuberbulous mycobacterium” (NTM), this bacterium is fairly common and usually innocuous. For patients with compromised immune systems who have undergone invasive surgery, however, it can be life-threatening. Some thirty cases were reported in the U.S. in 2016, and several more were reported in Europe. These numbers may only be only the tip of the iceberg, because NTM infections can have an incubation period of several months or even much longer. The bacterium infection may not even be identified for years. Symptoms, unfortunately, are common to many illnesses: muscle pain, chronic fatigue, fever. In addition, NTM can be resistant to most antibiotics.

Fatal Infection in half the cases
Some 250,000 open heart surgeries performed in the U.S. yearly employ heater-cooler units to regulate patient body temperatures. About 60% of these surgeries employ the Stockert 3T units.

FDA Safety Communication

The FDA issued a safety communication Oct. 15, 2015 regarding nontuberculous mycobacterium infections associated with the Stockert 3T Heater-Cooler devices.

FDA Statement on Contamination
LivaNova, a medical device manufacturer in Germany, makes the Stockert 3T. Recent investigations show these units were contaminated at the factory. The relevant manufacturing facilities were inspected in 2015, at which time they revealed numerous violations of standard safety protocols. In summer 2016, an FDA statement reported that nearly every Stockert 3T unit made before September of 2014 could be contaminated with NTM bacteria. Consequently, as many 500,000 people who have undergone open heart surgery since the device was introduced to the U.S. in 2006, could either suffer from, or be at risk of, developing an NTM infection. Most of these people are unaware of their exposure to the defective Stockert 3T heater cooler, though some have been notified.

Surgical Heater-Cooler Infections can be Fatal
The FDA is now issuing statements to health care facilities around the U.S., advising medical personnel to stop using the Stockert model and to use new accessories, such as tubing and connectors. This alternative should avoid recontamination of any replacement equipment. The FDA also strongly recommends that only water that has been carefully filtered be used for these devices.

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Indiana IVC Filter Case Filed

IVC FilterAn Indiana woman has filed an IVC filter case against Indiana-based Cook Medical, Inc., a/k/a Cook Medical Group. The petition was filed July 27, 2016 in Marion County Superior Court.

IVC Filter Perforation
The lawsuit petition states that the plaintiff was implanted with a Cook IVC filter in  April 2005. In May 2016, doctors discovered the Cook filter had perforated her IVC. The lawsuit further alleges that the woman is now at risk for future Cook filter fractures, migrations, perforations and tilting. It charges that she faces numerous health risks, including the risk of death. Further, for the rest of her life, she will require ongoing medical monitoring as well as anti-coagulants.

IVC Filters
IVC filters are designed to filter blood clots (called “thrombi”) that would otherwise travel from the lower portions of the body to the heart and lungs. IVC filters may be designed to be implanted either temporarily or permanently within the vena cava.

The inferior vena cava is a vein that returns blood to the heart from the lower portion of the body. In certain people thrombi travel from vessels in the legs and pelvis through the vena cava into the lungs. These thrombi often develop in the deep leg veins, causing “deep vein thrombosis” or DVT.  An IVC filter such as the Cook filter is designed to prevent thromboembolic events by filtering or preventing blood clots/thrombi from traveling to the heart and/or lungs.

The Indiana lawsuit petition says the Cook filter has caused the plaintiff to undergo medical treatment as a result of the device’s failure.

The petition reads: “Plaintiff has incurred significant medical expenses and has endured physical pain and suffering, mental anguish, loss of enjoyment of life, and other losses, some of which are permanent in nature. As a result of the failure of the Cook Filter, Plaintiff has become impaired and will remain so in the future. The defective Cook Filter remains in Plaintiff’s body.”

Lawsuit Counts
The lawsuit counts are Negligence, Strict Product Liability – Failure to Warn, Strict Product Liability – Defective Design, Breach of Express & Implied Warranty, Negligent Misrepresentation, Medical Monitoring, Punitive Damages, Loss of Consortium.

Medical Monitoring Case
The petition also makes a medical monitoring claim that intermittent imaging studies are needed to determine whether the Cook Filter has failed. Such imaging studies typically include computed tomography scan (CT Scan) to visualize the filter. CT Scan imaging produces an image of the filter to show whether it has fractured or migrated.

The petition also says that patients requiring medical monitoring are recommended to undergo regular and frequent imaging studies of the device or portions of it at least once or twice annually.  It charges that the potential for future device failure exists as long as the device, or portions of it, remains within the patient’s body.  Consequently, IVC filter patients require regular and frequent medical monitoring for the duration of the device’s life inside them.

Indiana IVC Filter Case Filed

Attorney David Matthews of Matthews & Associates represents the plaintiffs.  The case is Jane Doe v. Cook Incorporated, Inc., Cook Incorporated, Inc. a/k/a et. al in Marion County Superior Court, cause no. 49D101607CT026764.

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IVC Filter Lawsuit filed in Illinois

A Cook IVC gunther-tulipfilter lawsuit was filed in Illinois’ Cook County Sept. 12, 2016. The plaintiff’s surviving spouse filed the case against Loyola University Health System and Cook Medical Inc., an Indiana corporation. The case specifically concerns Cook’s Günther Tulip IVC filter.

Causes of Action
Causes of Action claimed in the petition are Negligence, Medical Negligence, Strict Product Liability – Failure to Warn, Defective Design, Manufacturing Defect, Breach of Express & Implied Warranty, Negligent Misrepresentation, Wrongful Death, Loss of Consortium.

Death of Plaintiff
The plaintiff died at age 78 in Sept. 2014. He had been implanted with a Cook IVC filter in 2009. According to the petition, the man received the implant prior to a spinal procedure at Loyola University Medical Center in Cook County, Illinois.

IVC Filter Failure
IVC filters are advertised to prevent deep vein thrombosis. The petition says autopsy performed at the Autopsy Center of Chicago revealed “massive bilateral acute pulmonary embolism; deep venous thrombosis and complete occlusion of the left iliac vein; and a recent pre-mortem thrombus within the IVC filter.”

IVC Filter Problems Known
The petition states that “Defendants knew or should have known of the dangerous propensities of the IVC filter (to) cause injury and subsequent death, similar to the injuries sustained by the Decedent.”

“Further,” the petition states, “several published clinical studies showed IVC filter lacked efficacy, were inferior to anticoagulation therapy, and were associated with higher rates of DVT, including one of the only randomized controlled trials ever performed on IVC filters PREPIC.”

The petition also charges that Cook continued to promote its Günther Tulip filter as safe and effective even though clinical trials did not support its long or short term efficacy.

IVC Filter Lawsuit filed in Illinois

The case is No. 2016L009027 in the Circuit Court of Cook County, Illinois Dept., Law Division. Defendants are Loyola University Health System, Cook Inc. et al. David P. Matthews of Matthews & Associates represents the plaintiff.

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Defective Hip Implant Verdict $1 Billion

A defective hip Billion">DePuyimplant verdict of $1 billion came last week. On Dec. 2, 2016 a Texas federal jury found Johnson & Johnson’s DePuy Orthopaedics Inc. unit liable for more than $1.04 billion in a six-plaintiff trial. The plaintiffs had all claimed injury from DePuy metal-on-metal artificial hips, which were part of the company’s Pinnacle line. In a previous bellwether trial over the same product, a jury awarded a $150 million verdict.

Metal on Metal Product Problems
The multi district litigation court in the DePuy hip litigation has been assembled over allegations that friction between the device’s metal socket and metal ball head rubs away billions of microscopic particles. Those particles pollute the bloodstream and surround tissue with “wear debris.”

The jury deliberated less than a day after a two-month trial. The jury found J&J and DePuy had negligently designed the hip implant, failed to warn surgeons about dangerous conditions related to it, and concealed the implant’s risks.

The verdict included $4 – $6 million per person in damages for injuries, pain and suffering; $1 million to each of four spouses for loss of consortium; $504 plus million against both defendants in punitive damages. The punitive damages came after the jury found the companies had acted with malice or fraud.

Negligent Design, Failure to Warn
Both DePuy and J&J were found liable for negligent design defect, negligent failure to warn, strict liability failure to warn, failure to recall, negligent misrepresentation, intentional misrepresentation, fraudulent concealment. The jury found J&J did not conspire with DePuy on the design defect claim, but did find J&J liable for conspiracy on the other six claims. J&J was also found liable for aiding and abetting DePuy, in seven different causes of action.

The jury awarded $4 million plus medical costs to each of four people who had a single hip replaced, and $6 million plus medical costs to each of two plaintiffs who had both hips replaced. Each of the plaintiffs was awarded $84 million in punitive damages against J&J and DePuy.

$84 Million Headache Money for Illegal Kickbacks
In closing arguments the plaintiffs’ lawyer reminded jurors of J&J testimony related to an $84 million settlement J&J made to end an investigation into allegations it paid doctors kickbacks. A witness for Johnson had said J&J wasn’t admitting wrongdoing, but had paid the money to make a headache go away.

A headache? $84 million is aspirin money to them,” the attorney said during closing arguments. He urged the jury to impose a penalty stiff enough to make Johnson & Johnson change its future behavior with medical devices.

Plaintiffs are from California; therefore, they are not subject to the same punitive damages cap that slashed by more than two-thirds the $502 million verdict from the second bellwether trial, which involved Texas plaintiffs.

J&J did win the first metal-on-metal hip trial, which involved a Montana plaintiff.

DePuy Responds to Verdict
DePuy said it would challenge the verdict on appeal. The company claimed it has strong grounds for appeal.

The attorney on the losing side complained that the, “[billion-dollar] verdict provides no guidance on the merits of the overall Pinnacle litigation because the court’s rulings precluded a fair presentation to the jury.” (Now) the appellate court will need to review errors repeated in two trials, and we will continue to urge that no further trials be conducted until we receive appellate court guidance.”

Defective Hip Implant Verdict $1 Billion

The cases involved six plaintiffs from California who had each undergone “revision surgeries” after being fitted with metal-on-metal artificial hip systems of DePuy’s Pinnacle Ultamet variety.

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Morcellator Options for Fibroids

Power Morcellator Surgery Riskmorcellators are not the only option for hysterectomy, myomectomy, or the removal of uterine fibroids, which some 80% of women can develop in their lifetimes.

In April 2014, the FDA announced in a safety alert that it wants to discourage the use of power morcellators. the problem is that some women may have undiagnosed uterine cancer which a morcellator can upstage, magnify, and make more dangerous, even deadly.

FDA Warning

FDA warned on April 17, 2014:

“Based on an analysis of currently available data, the FDA has determined that approximately 1 in 350 women who are undergoing hysterectomy or myomectomy for fibroids have an unsuspected type of uterine cancer called uterine sarcoma. If laparoscopic power morcellation is performed in these women, 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.”

Risk of Power Morcellaton

Power morcellation is less invasive than traditional forms of surgery; but it also carries the risk of spreading benign or malignant tissue when used during myomectomies or hysterectomies for fibroid treatment or uterus removal.

Alternatives to Power Morcellation
The FDA acknowledged that power morcellators are less invasive (as advertised) than traditional approaches. They require fewer sutures; but nonetheless the FDA’s Obstetrics and Gynecology Devices Advisory Panel recommends that women seek, and that surgeons use, alternative methods. Several non-surgical treatments exist for fibroids, including expectant management, pharmaceutical therapy, uterine artery embolization, endometrial ablation.

Surgical Options for Fibroid Treatment
If a woman does require surgery, she and her doctor can decide between a hysterectomy, complete removal of the uterus; or a myomectomy, which targets only the fibroids. Many factors enter into this decision, including age, a (possible) desire for pregnancy, history of atypical cervical or endometrial cells, family history of cancer, risk of fibroids’ return.

Traditional Options: Hysterectomy & Myomectomy

The traditional option for removing the uterus is total abdominal hysterectomy, which the FDA says is the most common surgical choice. This involves a surgical incision in the wall of the lower abdomen, compared with laparoscopic hysterectomy, which takes less time and usually produces fewer urinary tract injuries.

Supracervical, or subtotal, hysterectomy and total vaginal hysterectomy are other options. According to the American College of Obstetricians and Gynecologists, vaginal hysterectomy is the most preferred option due to benefits it provides compared with alternatives. FDA says vaginal hysterectomy allows faster recovery and less of a chance of inducing infections than abdominal hysterectomy.

When fibroids are removed instead of the entire uterus, an open abdominal myomectomy is a traditional option. This involves an abdominal wall incision similar to an abdominal hysterectomy, and it precludes the need for morcellation.

Risks of Laparoscopic Treatment

According to FDA, compared with vaginal hysterectomy, the laparoscopic alternative may cause more complications during surgery, more transfusions, and a longer time spent in the operating room. Laparoscopic hysterectomy uses multiple small incisions in the abdomen wall along with gas and visualization instruments. It is during these types of procedures that surgeons often use power morcellators to allow large tissue to be extracted.

The types of laparoscopic hysterectomy include laparoscopic-assisted vaginal hysterectomy, total laparoscopic hysterectomy, and laparoscopic supracervical hysterectomy. Each of these types may, at some point during the procedure, require some form of morcellation to allow for complete uterine removal.

In minimally invasive laparoscopic myomectomy, power morcellation or the extending of incisions are ways of removing the cut fibroids. Morcellation may also be used during hysteroscopic myomectomy, a transvaginal procedure that does not require an abdominal incision, for fibroids found within the endometrial cavity and inner myometrium.

Alternative Surgical Techniques

To promote surgical techniques that mitigate the risks of power morcellation, various options have been suggested as possible ways to prevent spreading of tissue while maintaining the claimed benefits of minimally invasive procedures.

En-bloc resection techniques remove tissue completely intact, hoping to avoid power morcellation and the risk of spreading tissue pieces. To that end, methods could be used such as minilaparotomy, a surgically enlarged ancillary port; or transvaginal extraction. Each of those procedures comes with its own set of potential complications, however, and it is unclear whether any alleviate the risk of tissue dissemination.

Containment Bags and Other Strategies

Some industry representatives argue that leaving power morcellators on the market will drive companies to find new solutions to mitigate their risks. Proposed methods include vaginal morcellation and transvaginal extraction. Most common are techniques that involve containment bags.

Morcellator Options for Fibroids

Techniques in “bag morcellation” have been floated as a means of reducing the risk of spreading (potentially) cancerous tissue. But after the FDA examined the limited data for the permeability, integrity, and ability to execute various morcellation techniques within various surgical bags and other “containment strategies,” the agency could not verify the efficacy of any of those methods for reducing the morbid and cancer-spreading risks of power morcellators.

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Power Morcellator Investigation by Government

The U.S. Government morcellator uterine cancerAccountability Office (GAO) has still not issued any statement regarding its investigation into power morcellators used for hysterectomy or uterine fibroids. The GAO announced in Sept. 2015 that it would investigate controversy which had stemmed from wide use of power morcellators, and subsequent morcellator lawsuits. These gynecological devices are known to spread undetected cancers during hysterectomies and myomectomies.

Congressional Letter to GAO
The GAO’s action came after a dozen members of Congress wrote a letter requesting that the agency investigate. The legislators wrote the GAO a letter dated August 2, 2015:

“Hundreds, if not thousands, of women in America are dead because of a medical device known as a laparoscopic power morcellator. (This) device can take a Stage 1 treatable cancer immediately to a Stage 4 terminal cancer. For too many women, this routine procedure ended with a death sentence.”

The representatives’ letter was signed by Reps. Mike Fitzpatrick (R-Pa.), Louise Slaughter (D-N.Y.), Ralph Abraham (R-La.), Rosa DeLauro (D-Conn.), Bill Pascrell, Jr. (D-N.J.), Lou Barletta (R-Pa.), Doug LaMalfa (R-Calif.), Anna G. Eshoo (D-Calif.), Jan Schakowsky (D-Ill.), Chris Smith (R-N.J.), Stephen Lynch (D-Mass.), and Rick Larsen (D-Wash.).

FDA Limits Morcellator Use
FDA severely limited power morcellator use in November 2014, a year after doctors and patient advocates Amy Reed and Hooman Noorchashm launched a vigorous campaign against the device.

Morcellator National Security Threat
Dr. Amy Reed became a power morcellator victim after one was used on her for a hysterectomy. Her husband, Dr. Hooman Noorchashm then became something of a whistleblower. He announced that morcellators were a national security threat, given that 1 in 350 women have undetected uterine cancer prior to hysterectomy or fibroid removal. When that woman with undetected cancer undergoes surgery with a morcellator, her cancer can be morcellated – sliced and diced – into millions of pieces which are then spread everywhere throughout the uterus. The result can be aggressive uterine cancer or other type of cancer that can be fatal.

Doctors push Back
Some doctors, meanwhile, have pushed back against the proposed morcellator ban. The morcellator offers the convenience of a less invasive procedure. Fewer sutures are needed in using the morcellator, compared with the old methods used for hysterectomy and myomectomy or fibroid removal. The problem remains, however, that the ovarian cancer testing which doctors have used prior to surgery in order to diagnose possible cancer has not proven reliable.

Morcellator Lawuits
Against this backdrop, morcellator lawsuits have been filed across the country for women with undetected cancer who then underwent surgery with a power morcellator, only to find that the machine spread and worsened their undetected cancer.

Power Morcellator Investigation by Government

Meanwhile, the power morcellator investigation by the U.S. government continues. Stay tuned for further developments. . .

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New Laser Technique removes IVC Filters

Despite thereIVC Filter Graphic being no evidence blood clot filters help the overall population, or that they increase mortality for trauma patients, some 250,000 IVC filters are implanted in people yearly. Even more concerning, many of these devices are not removed as soon as they should be. Research has meanwhile shown that the longer IVC filters remain in the body, the more likely they are to cause problems.  Fortunately, help may be on the way.

New Technology could save Lives

New technology is showing some promise, paving the way for the possible safe removal of IVC filters. New technology and methods could potentially save thousands of lives.

FDA recommends Quick IVC Filter Removal
Studies estimate that only 8% of IVC filters are removed from patients within 3.8 years of their being implanted. The FDA, meanwhile, recommends IVC filters be removed 24 to 59 days after being implanted.

The problem is that IVC filters aren’t always easy to remove, even within the recommended window; and the longer they remain implanted, the more difficult they can be to remove. IVC filters like those made by C.R. Bard, Cook Medical, and Cordis Corporation, have been named in blood clot filter lawsuits which allege they are prone to perforating the inferior vena cava wall. They can also migrate throughout the body and fracture, causing their parts to embed into vital organs. One client at Matthews & Associates Law Firm, which represents people who have filed IVC filter lawsuits, has an IVC filter embedded in a kidney. The entire kidney will likely need to be removed to safeguard the person’s life.

When an IVC filter fails within a person’s body, it can be extremely difficult to remove the device. Besides the kidneys, pieces can lodge in the heart or lungs,  and devices that have perforated the vena cava wall often can’t be removed without causing further damage.

Serious, Life-threatening Complications

IVC filters left inside one’s body can cause serious, life-threatening complications, including internal bleeding or strokes. Patients left with the defective devices may live in constant fear that the wrong movement could jar a jagged piece loose and cause fatal damage. Into this fearful scenario comes this hopeful news.

Five-Year Study shows Promise for Filter Removal

A five-year study examined the safety and efficacy of using advanced laser technology to remove previously irretrievable IVC filters. Endovascular laser-assisted retrieval has been applied to successfully remove several different types of IVC filters. Researchers who worked in the study believe that nearly all defective IVC filters can be removed using this laser technology.

New Laser Technique removes IVC Filters

More clinical studies need to be performed using this procedure, which for now appears able to give many thousands of people hope for a better, healthier future unencumbered by IVC filter fears.

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