Every year millions of people use a variety of medical devices believing that they are safe and that the devices will allow them to live healthier and fuller lives. However, defective medical devices can leave users at risk for a variety of debilitating injuries. The risk from defective medical devices is especially high for people who require their long-term use. We are continually evaluating product liability cases stemming from medical devices.
Medical devices must be approved by the U.S. Food & Drug Administration (FDA), but the manufacturer of the device is ultimately responsible to ensure the safety of its product. When a medical device is discovered to be defective, the manufacturer is responsible to inform the FDA and the public about the flaw and any potential risks. If the manufacturer of the medical device does not properly inform the public and the FDA in a timely manner about the defect, it can be considered an act of negligence and the manufacturer can be held liable for any injuries, illnesses or deaths that occur.
We are currently accepting potential claims for injuries caused by the following medical devices:
Transvaginal Mesh: Foulston Law Office is investigating cases in which recipients of transvaginal mesh (also called pelvic mesh) have suffered serious complications. From 2005 to 2010, there have been nearly 4,000 injuries reported to the FDA following the placement of a transvaginal mesh (TVM) device.
Reported complications involving pelvic mesh have been made regarding numerous manufacturers, including Boston Scientific, American Medical Systems, Inc. (AMS), C.R. Bard, Inc. and Johnson & Johnson.
The following injuries or side effects have been associated with the implantation of pelvic mesh products:
- Chronic vaginal drainage
- Erosion of the vaginal tissue
- Feeling as though something is protruding from the vagina
- Lower back pain
- Pain during intercourse
- Perforations of the bowel, bladder or blood vessels
- Pressure or feeling of “fullness” in the lower abdomen
- Reoccurrence of pelvic organ prolapse (POP) or stress urinary incontinence (SUI)
- Urinary problems
- Vaginal bleeding
- Vaginal infections
- Vaginal pain not related to intercourse
- Vaginal scarring
DePuy Hip Replacements: Foulston Law Office is reviewing potential hip replacement lawsuits for people implanted between 2005 and 2010 with the DePuy Orthopaedics ASR™ XL Acetabular Hip Replacement System, or implanted between 2001 and 2010 with the DePuy PINNACLE® Modular Hip Replacement System with metal insert/liner, and experienced pain or other symptoms that led to a second hip replacement surgery. The hip replacement devices are manufactured by DePuy Orthopaedics, a division of Johnson & Johnson Services, Inc., and both total hip replacement systems include the cup portion of a replacement hip.
Hip replacement side effects include:
- Blood test results that show high levels of chromium and cobalt caused by metal debris
- Clicking, popping or grinding in the area of the hip implant
- Device failure from loosening that results from bone loss
- Dislocation (the two parts of the implant move against one another and become misaligned)
- Fracture (bone around the implant breaking)
- Loosening in the hip joint (implant fails to stay attached to the bone in the correct position)
- Metal debris (component parts move together resulting in flecks of metal shavings that spread around the area surrounding the implant and destroy soft bone and tissue)
- Problems involving walking, pain, swelling or discomfort in the hip area
Zimmer Durom® Cup Hip Replacement: Foulston Law Office is currently accepting cases in which recipients of the Zimmer Durom® Cup have suffered from intense pain or injuries following hip replacement surgery.
In July 2008, Zimmer, Inc., voluntarily suspended the sale of Durom® Hip Resurfacing System in the United States after physicians expressed concern over a high failure rate with the hip replacement device.
The reports indicate that the Durom® Cup may fail to fuse properly with the bone, instead separating and migrating in the body. When the Durom® Cup moves, it pushes the metal hip socket against bone, which can cause excruciating pain for patients. Additionally, problems with the Durom® Cup may require patients to undergo hip revision surgeries, medical monitoring or rehabilitation.
Mirena IUD: The Mirena IUD [Intra-Uterine Device] was introduced by Bayer and approved by the FDA in 2000 as a long-acting form of birth control. It is inserted into the uterus to disrupt the egg and sperm. The device also releases the progestin levonorgestrel, which further acts to prevent pregnancy by keeping the woman’s ovaries from releasing eggs.
Although Mirena has been promoted as a safe and reversible form of birth control, which can prevent pregnancy for up to five years, women may face an unreasonable risk of problems, such as spontaneous migration and uterine perforation.
The Mirena IUD may move inside the body, potentially resulting in :
- Perforation of the uterine wall
- Migration of the IUD to outside the uterus
- Expulsion of the IUD
- Pelvic Inflamation
- Complications that require surgery to remove the IUD
If you believe that you may have been injured as a result of a medical device, contact Foulston Law Office for a free consultation.