Shezad Malik Law Firm Dr Shezad Malik Law Firm has offices based in Fort Worth and Dallas and represents people who have suffered catastrophic and serious personal injuries including wrongful death, caused by the negligence or recklessness of others. We specialize in Personal Injury trial litigation and focus our energy and efforts on those we represent.

Articles Tagged with Ethicon

Ethicon Physiomesh is “not safe”according to lawsuit. John Guerra, from Torrance California claims that the Ethicon Physiomesh patch used in his hernia repair causes severe health risks and complications. According to Guerra, he developed a chronic seroma and required many additional surgeries.

Ethicon Physiomesh is "not safe"according to lawsuit. Ethicon Hernia mesh linked to adhesions, perforation, infection and the need for removal surgery.

Ethicon Physiomesh is “not safe”according to lawsuit. Ethicon Hernia mesh linked to adhesions, perforation, infection and the need for removal surgery. 

A seroma is a pocket of clear serous fluid that sometimes develops in the body after surgery. This fluid is composed of blood plasma that has seeped out of ruptured small blood vessels and inflammatory fluid produced by the injured and dying cells.

Man claims that Ethicon hernia mesh adhesions injuries were due to the plastic product. Charles Racine from Delaware recently filed a product liability lawsuit because of injuries from the Ethicon Physiomesh that was used during his ventral hernia repair.

Ethicon Hernia mesh adhesions lawsuits

Ethicon Hernia mesh adhesions lawsuits. Ethicon Hernia mesh linked to adhesions, perforation, infection and the need for removal surgery.

Racine filed his claim against Johnson and Johnson and its unit, Ethicon in Maryland federal court. According to Racine, he developed small bowel adhesions and had to have the hernia mesh surgically removed from his body.

Ethicon Vaginal mesh lawsuit ends in plaintiff’s verdict. The jury in a Philadelphia state court jury found for a plaintiff and awarded a $20 million verdict against Johnson & Johnson’s Ethicon division, over complications with the Ethicon TVT-Secur transvaginal mesh.

Ethicon Vaginal Mesh Side Effect Lawsuits

Ethicon Vaginal mesh and bladder sling for repair of pelvic organ prolapse and urinary incontinence may lead to pain, further surgery, recurrence of symptoms and erosion of the devices through soft tissue.

Philadelphia Ethicon Vaginal Mesh Trial

Recently, a Georgia Ethicon Physiomesh hernia failure lawsuit was filed by Connie Franklin, in the U.S. District Court for the Middle District of Georgia.

Ethicon Physiomesh Hernia Mesh lawsuit

Ethicon Physiomesh Hernia Mesh linked to infections, failure of the device, serious injuries including bowel perforation according to many lawsuits

According to Franklin, Johnson & Johnson (J&J), the world largest pharmaceutical and medical device maker and Ethicon its subsidiary, sold a defectively designed and unreasonably dangerous hernia repair device.

Babette Davis from Wisconsin filed a morcellator product liability lawsuit in the U.S. District Court for the Eastern District of Wisconsin against Johnson & Johnson’s Ethicon unit after being diagnosed with leiomyosarcoma, a deadly aggressive form of uterine cancer. According to Davis, the Johnson & Johnson’s Ethicon Gynecare power morcellator that was used during the laparoscopic hysterectomy caused the undiagnosed uterine cancer to be spread throughout her abdomen and pelvis.

Uterine_Cancer_Hysterectomy_AttorneyDavis has to take expensive oral chemotherapy drugs to keep the leiomyosarcoma cancer from spreading further and she knows that beating the uterine cancer is going to be a tough battle that she may not win.

Increased Risk of Cancer Spread After Morcellator Use

Michael G. Fitzpatrick, representative of the 8th district of Pennsylvania, has asked the FDA’s Office of Criminal Investigations, to investigate whether three hospitals violated mandatory reporting policies in wrongful deaths related to the use of power morcellators during gynecological surgery.

Uterine_Cancer_Hysterectomy_AttorneyBrigham and Women’s Hospital (of Boston); Rochester General Hospital; and the University of Rochester Medical Center are implicated in failing to report these surgical deaths, that were likely related to the use of morcellators at the hospital as part of surgical procedures there.

What are Power Morcellators?

According to the U.S. Food and Drug Administration (FDA), the popular plastic transvaginal mesh device that has been used to repair pelvic organ prolapse (POP) transvaginally, or through the vagina, will have to undergo rigorous safety studies before being available to be used in patients.

The FDA issued two final orders to vaginal mesh manufacturers and notified the public that the agency is strengthening the medical data requirements for surgical mesh.

Trans Vaginal Mesh AttorneyFDA Classifies Plastic Vaginal Mesh as High Risk

Recently, a Philadelphia jury found for the plaintiff Patricia Hammons, who suffered serious internal injuries from the Ethicon Prolift vaginal mesh. Johnson and Johnson, the manufacturer is exposed to at least fifty thousand similar claims, with hundreds of lawsuits fast tracked for early trial in 2016.

Trans Vaginal Mesh Attorney$12.5M Verdict and Punitive Damages Awarded

Hammons, was awarded $5.5 million in compensatory damages and $7 million in punitive damages against Johnson & Johnson’s Ethicon subsidiary. Punitive damages are rarely awarded in product liability and personal injury lawsuits, and are designed to punish the company for gross negligence and reckless disregard for the safety of patients.

In the United States, Hysterectomy is the second most frequently performed surgical procedure (after cesarean section). The majority of these hysterectomies are performed laparoscopically.

Uterine_Cancer_Hysterectomy_Attorney

What is Laparoscopic Hysterectomy?

Minimally invasive or laparoscopic removal of the uterus, is know as hysterectomy and typically performed for the treatment of fibroids or benign tumors of the uterus. During the surgery, many doctors remove the uterus in pieces using a mechanical grinding or chopping device known as a power morcellator.

Recently, many personal injury and wrongful death lawsuits being filed against the manufacturers of power morcellators. The injured women claim that patients and doctors should have been warned about the risks associated with use of the medical devices during minimally invasive, laparoscopic hysterectomies.

What Are Power Morcellators?

Power morcellators are medical devices that are used during laparoscopic hysterectomy and myomectomy (fibroid removal) procedures. The device allows the surgeon to grind up the uterus or uterine fibroids and remove the tissue through a small incision in the abdomen. The medical device is used during minimally invasive surgery, and reduces recovery time, scarring and speeds up recovery time.

How Morcellator Increases the Risk of Uterine Cancer Spread

According to medical experts and the FDA, about one out of every 350 women undergoing a laparoscopic hysterectomy with morcellation may have undiagnosed sarcoma, which doctors are unable to detect before the surgery. Undiagnosed uterine sarcoma is highly malignant and is a lethal form of cancer, with poor life expectancy and treatment options. Most women die shortly after diagnosis and there are no curative treatments.

There is no bullet proof way for doctors to diagnose the uterine cancer before using the morcellator devices. Because of this, the FDA strongly urged doctors to avoid using the devices for laparoscopic hysterectomy or myomectomy procedures in April 2014. The FDA issued a BLACK BOX WARNING against the use of these devices in November 2014.

Power morcellators spread this undiagnosed leiomyosarcoma, endometrial stromal sarcoma or other cancer throughout the pelvis and abdomen during the grinding process, leading to rapid upstaging of the cancer and reducing the risk of long-term survival. As this risk becomes known, many doctors and hospitals have stopped the use of power morcellators over the past year.

Morcellators Approved Under the 510(k) Program

The controversial 510(k) program allows medical devices to be approved without pre-market testing requirements. Under the program, the manufacturer just needs to show that the devices are “substantially equivalent” to devices already on the market. Power morcellators were approved under the 510(k) process without any safety testing.

J&J Ethicon Morcellator Recall

All Ethicon power morcellators were recalled by the manufacturer, in 2014. J&J, acknowledged that the devices pose an unreasonable risk of spreading uterine cancer. Ethicon, a J&J subsidiary requested that hospitals voluntarily return all laparoscopic surgery morcellators. The company, noted that it will no longer sell the devices since there is no way to make them safe.

FDA Morcellator Black Box Warning

The FDA announced November 24, 2014 that it is adding a black box warning to uterine morcellator devices that remain on the market. A BLACK BOX WARNING, is the strongest warning that can be placed on any medical device.

Patients, doctors and hospitals are now on notice of the potential danger of increased uterine cancer spread risk associated with the use of these devices. Furthermore, the FDA announced that power morcellators should not be used with women near menopause or post-menopausal, or in women who could have tissue removed through the vagina or via a small incision.

This contraindication prohibits the use of the devices in the vast majority of women who undergo laparoscopic or vaginal uterine morcellation procedures.

Power Morcellator Litigation Centralized

Many complaints have been filed in the federal court system nationwide. These women were diagnosed with the spread of leiomyosarcoma, endometrial stromal sarcoma or other cancers following uterine fibroid surgery.

The U.S. District Court for the District of Kansas was recently approved for the centralization and consolidation in a multidistrict litigation (MDL) court. This is centralized only against Johnson and Johnson’s subsidiary, Ethicon morcellator manufacturer.

This means that all federal morcellator lawsuits will be consolidated for pre-trial discovery and early bellwether trials in the U.S. District Court for the District of Kansas. Federal courts consolidate lawsuits to MDLs when a large number of plaintiffs claim the same facts against the same defendant. The process allows the courts to operate more efficiently and decreases the costs for all parties involved.

All of the lawsuits filed against manufacturers of these devices claim that hysterectomy morcellators are unreasonably dangerous and that information about the risk of uterine cancer being spread was withheld from the patients and doctors.

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Short answer, yes, by causing the spread of undiagnosed malignant uterine cancer. In American women who are of reproductive age, Hysterectomy is the second most frequently performed surgical procedure (after cesarean section). The majority of these hysterectomies are performed laparoscopically.

Uterine_Cancer_Hysterectomy_AttorneyAccording to the Centers for Disease Control and Prevention (CDC), from 2006-2010, 11.7 percent of women between the ages of 40-44 had a hysterectomy.

Approximately 600,000 hysterectomies are performed annually in the United States, and approximately 20 million American women have had a hysterectomy.

By the age of 60, more than one third of all women have had a hysterectomy. According to the National Women’s Health Network (NWHN) unnecessary hysterectomies have put women at risk, and that doctors should search for hysterectomy alternatives before performing  life-changing operations.

What is Laparoscopic Hysterectomy?

Minimally invasive or laparoscopic removal of the uterus, is know as hysterectomy and typically performed for the treatment of fibroids or benign tumors of the uterus. During the surgery, many doctors remove the uterus in pieces using a mechanical grinding or chopping device known as a power morcellator.

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