MORE Kugel Mesh Lawsuits....severe injuries reported

Bard Composix Kugel Mesh Patches have been recalled several times over safety issues caused by product defects. The patches, which are used to treat ventral hernias, contain flexible rings that allow large patches to be folded for insertion through small incisions. Once the patch is in position within the abdominal cavity, the ring pops open allowing the patch to be fastened flatly in place. However, the Food and Drug Administration has received numerous reports of defective recoil rings breaking and exposing jagged, sharp edges. These sharp edges can cause serious internal injuries.

If you or a loved one has suffered the serious side effects of a defective Bard Composix Kugel Mesh Patch, please contact the experienced defective medical device attorneys at Buttafuoco & Associates today for a complimentary consultation who can help you recover the compensation you may be due.

Potential Injuries

When a Bard Composix Kugel Mesh Patch malfunctions, serious internal injuries can occur. Some of the injuries caused by malfunctioning Kugel Mesh Patches include:

• Intense abdominal pain
• Bowel perforation
• Intestinal fistulae, or abnormal passages between intestines

If you have been implanted with a Bard Composix Kugel Mesh Patch and are experiencing symptoms such as fever, persistent abdominal pain, tenderness, or other unusual abdominal symptoms, seek professional medical help immediately.

Recalled Bard Composix Kugel Mesh Patches

The following are the Bard Composix Kugel Mesh Patches affected by the recall:

• Composix Kugel Extra Large Oval (7.7" x 9.7") Product code: 0010208
• Composix Kugel Extra Large Oval (8.7" x 10.7") Product code: 0010206
• Composix Kugel Extra Large Oval (10.8" x 13.7") Product code: 0010207
• Composix Kugel Large Oval (5.4" x 7") Product code: 0010202
• Composix Kugel Oval (6.3" x 12.3") Product code: 0010209
• Composix Kugel Large Circle (4.5" in diameter) Product code: 0010204

Robotic Surgery ERROR Cover-up - Thousands Injured or Dead.

In March of  2009, Erin Izumi, a 30 year-old woman from Tacoma, Wash., had robotically assisted surgery to treat endometriosis. The procedure at St. Joseph Medical Center dragged on for almost 11 hours.

A week and a half later, Ms. Izumi was rushed to an emergency room, where physicians found that her colon and rectum had been torn during the surgery. She was in the hospital for five weeks, undergoing a series of corrective procedures to repair the damage, including a temporary colostomy, according to her attorney Chris Otorowski.

But even though medical device manufacturers and hospitals are required to report every device-related death and serious injury to a database maintained by the Food and Drug Administration within 30 days of learning about an incident, no report about the case was made in 2009. Hospital officials declined to comment, and a spokeswoman for the manufacturer said it became aware of the incident only when Ms. Izumi filed a lawsuit. It disputed the claim and settled the case in May 2012.

That was not the only lapse in reporting problems with robotic surgical equipment, a new study has found.
The equipment, called the da Vinci system, is made by Intuitive Surgical Inc. of Sunnyvale, Calif. It has been on the market for more than a decade; more than a million procedures have been performed with it. Between January 2000 and August 2012, thousands of mishaps were reported to the F.D.A. In the vast majority of cases, the patient was not harmed, but among the reports were 174 injuries and 71 deaths related to da Vinci surgery, according to a study published last week in The Journal for Healthcare Quality.

Yet by combing news reports and court records, researchers at Johns Hopkins were able to find examples of botched operations that were not reported to the agency. They concluded that adverse events associated with the da Vinci were “vastly underreported.” The consequence is that little is known of the real disadvantages of the equipment, and the injuries and deaths it may cause, even as robotic surgery is widely marketed to consumers, Dr. Zuckerman said.

Nevertheless, robotic surgery has grown dramatically, increasing more than 400 percent in the United States between 2007 and 2011. About 1,400 da Vinci systems, which cost $1.5 million to $2.5 million, have been purchased by hospitals, according to Intuitive’s investor reports.

The expansion has occurred without proper evaluation and monitoring of the benefits, said Dr. Martin A. Makary, an associate professor of surgery at Johns Hopkins and the senior author of the paper.
“This whole issue is symbolic of a larger problem in American health care, which is the lack of proper evaluation of what we do,” Dr. Makary said. “We adopt expensive new technologies, but we don’t even know what we’re getting for our money — if it’s of good value or harmful.”

A 2010 study found that 56.8 percent of surgeons surveyed anonymously said they had experienced irrecoverable operative malfunctions while using the da Vinci system, Dr. Makary noted.
Women were more likely to be harmed during the robotic procedures, Dr. Makary and his colleagues found. Nearly one-third of deaths that were reported to the F.D.A. database occurred during gynecologic procedures, and 43 percent of the injuries were associated with hysterectomies.
“Any time there is a serious problem with the da Vinci, it should be reported,” Dr. Zuckerman said. “It’s the F.D.A.’s job to figure out whether this is a problem related to the device or a doctor error.”

If you or someone you know has been injured due to a defective medical device or negligence of a doctor call the experienced medical malpractice and defective products attorneys at Buttafuoco & Associates. 1-800-669-4878

RECALL ALERT: Reusable Breathing Circuit will cause serious injury

Date Class I Recall Initiated: January 3, 2013
Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.
Product: Reusable Breathing Circuit

Device Model: 900MR068

Lot Numbers: 110810 and 111020

Use: The Fisher & Paykel Healthcare reusable breathing circuit is a non-heated breathing circuit intended for oxygen therapy delivery for adult patients.

Recalling Firm:
Fisher & Paykel Healthcare Limited
15365 Barranca Parkway
Irvine, California 92618

Reason for Recall: The tubes used in the reusable breathing circuit have pinholes. If these pinholes are not detected during the standard leak test before patient use, it could potentially result in a gas leak in the breathing system, which may lead to a loss of pressure for the intended ventilation therapy. Usage of the defective device may result in patient death.

If you or someone you know has suffered injury due to a defective Reusable Breathing Circuit call the experienced defective medical device attorneys at Buttafuoco & Associates 1-800-6694878