Medical Devices
On April 4, 2009 the U.S. Food & Drug Administration (FDA) and Tri-State Hospital Supply Corporation initiated a nationwide class 1 recall of various Tri-State Centurion and Lee Medical branded medical devices due to the potential that weak package sealing may affect the sterility of the devices.
Lack of sterility in medical devices can pose, serious, life-threatening infections and other adverse events.
If you or a loved one have been injured by any of the recalled Tri-State Centurion or Lee Medical products, you should contact us immediately. You may be entitled to compensation for your injuries and we can help.
Tri-State Hospital Supply Corporation Recall List
Do I Have a Defective Medical Devices Lawsuit?
Again, if you or a loved one have been injured by any of the recalled Tri-State Centurion or Lee Medical products, you should contact us immediately. You may be entitled to compensation for your injuries and we can help.
On January 2, 2009, the U.S. Food and Drug Administration (FDA) announced an urgent, nationwide recall of Healon D, manufactured by Advanced Medical Optics, Inc. The ophthalmic viscosurgical device has been recalled due to complaints of post-operative intraocular inflammation after eye surgery, including Toxic Anterior Segment Syndrome (TASS).
If you or somebody you know has developed eye inflammation or TASS after having eye surgery where Healon D was administered, you should contact us immediately. You may be entitled to compensation and we can help.
This recall of Healon D is limited specifically to lot number UD30654.
According to AMO, they have received 66 adverse event reports associated with the recalled product(s). Tests of lot number UD30654 revealed elevated levels of endotoxin, which has been associated with post-operative intraocular inflammation and TASS.
What is Toxic Anterior Segment Syndrome (TASS)?
TOXIC ANTERIOR SEGMENT SYNDROME (TASS) is a rare, potentially devastating complication of routine intraocular surgery that occurs when a noninfectious toxic agent enters the anterior segment of the eye, causing an inflammatory reaction.
SEVERE CASES OF TASS can cause permanent harm, and if symptoms still are present after six weeks, the eye is not likely to recover.
EARLY DIAGNOSIS AND TREATMENT are effective in preventing permanent damage, but often TASS is mistakenly diagnosed as infectious endophthalmitis for which treatment is completely different.
The Neomedic Company of Europe has released several products into the American market for treating cases of urinary stress incontinence. Introduced to the public in early 2007, this line of products was first named REMEEX but was later changed to ContaSure for the American market. There are products in this line that can be used to treat either female or male urinary incontinence and each of the products have been determined to be an effective cure for the condition.
Neomedic has created two different products for use in treating female urinary stress incontinence, a single incision Needleless Sling System and an Adjustable Sling System. The products are designed to correct the involuntary leakage of urine due to the condition and return the person to their previous comfort levels for doing the things that they normally enjoy. Many of the people that are suffering from urinary stress incontinence are embarrassed about the condition and tend to remove themselves from the people and the places that they love because they are fearful of having an accident while other people are around.
People that suffer from urinary stress incontinence find that they have involuntary bladder leakage when stress is placed on the abdominal cavity. The amount of stress that causes the leakage range from minimal to great, depending on the strength of the pelvic floor, and can be triggered by coughing, sneezing, laughing, certain movements, or pressure. In most cases, the condition occurs because the muscles on the floor of the pelvis are too weak to support the urethra in the proper placement, allowing it to drop when stress is placed on the abdomen and allowing urine to leak out of the bladder.
Although surgical treatment is considered to be a last resort for physicians with patients experiencing urinary stress incontinence, thousands of women have undergone surgical procedures to have transvaginal mesh devices, like the Neomedic Sling Systems, implanted for a permanent solution to their condition. The surgical procedure is generally performed on an outpatient basis and can be performed in less than an hour under general anesthesia. The procedures used are considered to be minimally invasive and allows the person to return to their normal activities within a few days of having the surgical procedure.
Over the last several years, a number of reports have been made to the US Food and Drug Administration about complications associated with the use of the transvaginal mesh devices, like the Neomedic Sling Systems. Some of the complications that have been reported to the agency have severely diminished the patient’s quality of life and have even become life threatening, requiring prompt medical attention to preserve the health of the patient. Because of the high number of reports made to the US Food and Drug Administration, the agency released a warning about the numerous complications associated with the devices with a recommendation for physicians to ensure that this option is truly the best option for the patient before performing the surgical procedure.
Do I Have a Transvaginal Mesh Lawsuit?
If you or somebody you know has been injured or suspect that you may have a serious complication directly linked to a Pelvic Organ Prolapse (POP) and Stress Urinary Incontinence (SUI) procedure, and/or the placement of a transvaginal mesh product, you should contact and Injury Help Network attorney immediately. You may be entitled to compensation for your injuries and our lawyers can help.
Please use the form below or call toll free 24 hrs/day by dialing (866) 588-0600 to contact us for a free case evaluation of your potential transvaginal mesh claim.
The Mentor ObTape Vaginal Sling is manufactured by the Mentor Corporation and has been approved for use in the treatment of female stress urinary incontinence by the US Food and Drug Administration since 2003. The device is designed to support the weakened muscles on the floor of the pelvis from the inside of the vaginal walls which props up the bladder into its proper position. This reduces instances of the condition by a significant amount and can return the patient to their previous quality of life.
The Mentor ObTape Vaginal Sling is implanted during an outpatient procedure that typically takes around 30 minutes to complete. As stress urinary incontinence is believed to affect nearly 13 million women across the nation, there are many that have chosen to have the device implanted as a permanent cure for the condition. The minimally invasive procedure that is used for placing the device allows the patient to heal quickly and return to their normal activities within a matter of weeks.
A significant percentage of the women that had the Mentor ObTape Vaginal Sling implanted as a treatment for female stress urinary incontinence began to experience complications related to the devices not long after the items were introduced to the public. Some of the most common complications experience extreme vaginal pain, infections, urinary tract erosion, and vaginal extrusion. Many of the patients found it necessary to undergo further surgical procedures to remove the device and repair the damage that had been done.
Because of the high percentage of women that experienced adverse events associated with the use of the Mentor ObTape Vaginal Sling, the device was removed from the market. Many of the women that experienced complications associated with the device found that they continued to have severe pain after the device was removed and the scarring caused by the device has made having sexual intercourse uncomfortable and unpleasant. The diminished quality of life for these patients has been found to be very difficult to return to its former levels and many patients find that the effects of the complications affect them for the rest of their lives.
Thousands of women have had the Mentor ObTape Vagina Sling used in a procedure to correct female urinary incontinence and of these women, nearly 20% of them have or will experience serious complications associated with the device. In the past three years, the US Food and Drug Administration has received numerous reports of complications associated with the use of this and other transvaginal mesh devices, prompting the agency to release a warning to the healthcare community about the dangers linked to the use of the devices. If a person believes that they may be experiencing complications associated with the implantation of the Mentor ObTape Vaginal Sling, they should seek medical treatment immediately to preserve their health and prevent the issue from becoming more serious.
Do I Have a Transvaginal Mesh Lawsuit?
If you or somebody you know has been injured or suspect that you may have a serious complication directly linked to a Pelvic Organ Prolapse (POP) and Stress Urinary Incontinence (SUI) procedure, and/or the placement of a transvaginal mesh product, you should contact and Injury Help Network attorney immediately. You may be entitled to compensation for your injuries and our lawyers can help.
Please use the form below or call toll free 24 hrs/day by dialing (866) 588-0600 to contact us for a free case evaluation of your potential transvaginal mesh claim.
One of the newest innovations for the treatment of female urinary stress incontinence is the TVT-Secur System, manufactured by Gynecare and marketed by Johnson & Johnson. The TVT-Secur System is designed to reduce the involuntary leakage of urine when the abdomen experiences stress, such as when the person is laughing, coughing, sneezing, or moving in a certain manner. Experts estimate that there are millions of women across the nation that suffer from female urinary stress incontinence and a significant percentage of these women have decided that the use of the TVT- Secur System was the best option to correct their problem.
The TVT-Secur System uses a mesh tape that is formed into a sling to support the urethra and position it so that the involuntary leakage of the bladder is halted. The device is implanted through a small incision in the vaginal area and placed against the vaginal wall to provide support to the weakened area of the pelvic floor that is allowing the urethra to move out of position. The procedure to implant this transvaginal mesh device is typically performed on an outpatient basis under local anesthesia and takes no longer than one-half hour to complete.
There have been a number of risks associated with the procedure to implant the transvaginal mesh device and with the device itself. Over the last three years, the US Food and Drug Administration has received around one thousand reports of adverse events linked to the TVT- Secur System and other transvaginal mesh devices. In some cases, the complications that develop are considered to be life threatening and will require the person to be subjected to painful surgical procedures to remove the mesh device from their body and repair the damage that the procedure has caused.
Some of the most common complications reported to the US Food and Drug Administration include perforations of the bowel, bladder, or blood vessels. This could result in severe infections and significant blood loss that could threaten the health of the patient. Cases of vaginal scarring and painful sexual intercourse has also been reported to the agency, with many of the individuals affected never regaining their previous quality of life. Other complications associated with the usage of the devices include the development of abscesses, erosion of the device, urinary problems, and a recurrence of the prolapse.
Medical professionals across the country have recently received an alert from the US Food and Drug Administration warning them to be alert for any patients that have undergone a procedure for treating urinary stress incontinence developing complications due to the use of a transvaginal mesh device. In many of these cases, preserving the patient’s quality of life will depend on quickly correcting any issues that arise with prompt medical treatment. If a person believes that they have developed a complication because of a transvaginal mesh device, it is important that they seek medical help quickly to prevent further damage to the body from occurring.
Do I Have a Transvaginal Mesh Lawsuit?
If you or somebody you know has been injured or suspect that you may have a serious complication directly linked to a Pelvic Organ Prolapse (POP) and Stress Urinary Incontinence (SUI) procedure, and/or the placement of a transvaginal mesh product, you should contact and Injury Help Network attorney immediately. You may be entitled to compensation for your injuries and our lawyers can help.
Please use the form below or call toll free 24 hrs/day by dialing (866) 588-0600 to contact us for a free case evaluation of your potential transvaginal mesh claim.
Secure 128-bit SSL Encrypted Email Communication
