Were you injured by Boston Scientific vaginal mesh? These sling-like medical devices are implanted to help support weakened pelvic muscles. Unfortunately, they have caused thousands of serious injuries — including life-threatening infections, perforation of internal organs, scarring, nerve damage, chronic pain that interferes with sexual intercourse, and more. There are currently more than a thousand transvaginal mesh lawsuits pending in federal court.
Do I Have a Boston Scientific Vaginal Mesh Lawsuit? Collen A. Clark is a true advocate for his clients and is passionate about helping Texans that have been injured or wronged. If you or a loved one has been injured after being implanted with Boston Scientific vaginal mesh, you should contact our lawyers immediately. You may be entitled to compensation by filing a Boston Scientific vaginal mesh lawsuit.
Boston Scientific Vaginal Mesh
Boston Scientific has created several vaginal mesh products, including the following:
- Uphold Vaginal Support System
- Polyform Synthetic Mesh
- Pinnacle Pelvic Floor Repair Kit
- Advantage Fit Sling System
- Obtryx Sling System
- Prefyx Sling System
- Solyx Sling System
- Lynx Sling System
Transvaginal Mesh (also known as “vaginal mesh” or “pelvic mesh”) is a type of medical device that is used to repair Pelvic Organ Prolapse (POP) or Stress Urinary Incontinence (SUI). These two disorders are common complications of pregnancy, and they occur when weakened muscles in the pelvis allow organs to protrude into the vagina, or allows the urethra to open when a woman laughs, coughs, or sneezes. Approximatley 300,000 women were implanted with these devices in 2011 alone.
Recalls of Boston Scientific Vaginal Mesh
Boston Scientific was a pioneer in the field of transvaginal mesh devices. Their first product, the ProteGen vaginal sling, was introduced in the mid-1990s. Unfortunately, the device was associated with a high risk of complications. Just a few years later, Boston Scientific recalled the device due to safety concerns. Several later transvaginal mesh devices were based on this product’s defective design, and yet the FDA did not require safety studies.
Boston Scientific issued another vaginal mesh recall on August 3, 2011. This time, the recalled product was the Boston Scientific Pinnacle Pelvic Repair Kit. According to the recall notice, “the device may exhibit low tensile strength between the needle and suture and lead to needle detachment during mesh leg placement.” During the placement surgery, a detached needle could potentially perforate nearby internal organs.
Vaginal Mesh and the FDA
The FDA has issued two major safety announcements regarding the high risk of complications associated with transvaginal mesh. The first announcement was made in 2008, after the FDA received approximately 1,000 reports of severe complications — most commonly, erosion of the device into the vaginal wall. The FDA also warned that they had received many reports of organ perforation.
The FDA issued a second safety announcement in 2011, announcing that since the 2008 announcement, they had received nearly 3,000 additional reports of severe complications. The FDA stressed that complications were “not rare,” and therefore patients and doctors should carefully consider the risks and benefits of vaginal mesh therapy.
The FDA has also faced ongoing criticism over the way that it approved vaginal mesh. Many of the devices were approved based on a 510(k) application, which does not require manufacturers to conduct safety studies so long as the device is “substantially similar” to a device that has already gained FDA approval. Unfortunately, the “similar” device was one that Boston Scientific had recalled in the 1990s.
Boston Scientific Vaginal Mesh Side Effects
Boston Scientific vaginal mesh devices have been linked to the following severe complications and side effects:
- Life-threatening infection
- Device erosion into the vaginal wall
- Perforation of nearby internal organs, such as the bladder, bowel (intestines), or blood vessels
- Vaginal scarring, disfigurement, or shortening of the vagina
- Vaginal bleeding
- Chronic pain that interferes with sexual intercourse
- Nerve damage
- Return of Pelvic Organ Prolapse (POP) or Stress Urinary Incontinence (SUI)
Most women who have a serious complication require additional surgery to remove the defective device, repair damage to internal organs, or replace the device. This can extremely painful, debilitating, and expensive. Not all complications can be repaired. A serious infection, for example, can cause permanent damage to the vagina and significantly decrease a woman’s quality of life.
Boston Scientific Vaginal Mesh Lawsuit
Currently, four different manufacturers of vaginal mesh (including Boston Scientific) face more than one thousand vaginal mesh lawsuits in a federal Multidistrict Litigation (MDL) in the U.S. District Court for the Southern District of Virginia. Boston Scientific faces at least 183 vaginal mesh lawsuits, but it is likely that more will be filed as the litigation progresses. The first bellwether trial will begin in February 2013.
If you have suffered an injury caused by Boston Scientific vaginal mesh, you may still have time to file a lawsuit and join the ongoing litigation. You may be entitled to financial compensation for your past and future medical expenses, pain and suffering, lost wages, decreased quality of life, and more.
Do I have a Boston Scientific Vaginal Mesh Lawsuit?
Collen A. Clark is a true advocate for his clients and is passionate about helping Texans that have been injured or wronged.
Collen’s amazing success in the courtroom and well known dedication to his clients has earned him the recognition of his peers as one of The Top Trial Lawyers in Texas.”
The Clark Firm has assembled a team of trial lawyers with more than 100 years experience, participation in over 600 jury trials and $60 million in verdicts and/or settlements. Please use the form below to contact us for a free Boston Scientific Vaginal Mesh lawsuit review.