June 27, 2024 | Reading Time: 6 min Bladder sling surgery, medically known as transvaginal mesh surgery, is a common procedure aimed at addressing stress urinary incontinence (SUI) and pelvic organ prolapse (POP) in women. While many patients experience significant improvements following the procedure, there are a number of patients that experience complications.
Complications from bladder sling surgery sometimes result in patients filing claims for the injuries they’ve sustained. If you or a loved one has experienced adverse effects due to bladder sling surgery, it’s crucial to understand your rights and the potential for legal recourse.
What is a Bladder Sling?
A bladder sling is a medical device designed to support the urethra and bladder neck. It assists in stopping urinary incontinence by providing the necessary support to the weakened tissues. The materials used in bladder sling surgery typically range from your own biological tissue to a synthetic mesh. Due to its minimally invasive nature, the surgery has been a preferred method for treating SUI and POP.
Common Complications of Bladder Sling Surgery
While many individuals benefit from this surgery, it isn’t without risks. Bladder sling procedures can result in complications ranging from mild to severe. Some of the commonly reported complications include:
- Mesh Erosion: One of the most severe complications, mesh erosion occurs when the mesh erodes through the vaginal tissue. This erosion can lead to severe pain, infections, and even necessitate additional surgeries.
- Chronic Pain: 42.3% of patients reported chronic pain following the surgery, particularly in the pelvic region.
- Infections: As with any surgical procedure, there’s a risk of infection. However, the risk is exacerbated with bladder slings due to the nature of the mesh material.
- Organ Perforation: The mesh can sometimes perforate or puncture nearby organs, such as the bladder or intestines.
- Urinary Problems: Instead of resolving incontinence issues, some patients find their urinary problems persist or worsen post-surgery.
- Sexual Dysfunction: Pain during intercourse or reduced sexual function is another complication many patients face after surgery.
Unfortunately, these injuries can cause recurrence or worsen urinary problems. Despite the associated risks, most doctors use mesh slings made of polypropylene for bladder sling surgeries.
FDA Warnings and Actions
In 2011, the U.S. Food and Drug Administration (FDA) issued a safety communication, identifying the concerns and new recommendations for the use of surgical mesh for transvaginal mesh repair. The communication highlighted that complications were not rare and could be severe.
By 2016, the FDA reclassified the surgical mesh for transvaginal repair of POP to a high-risk class III device. This reclassification necessitated more stringent regulatory controls and premarket approvals.
Bladder Sling Recalls
There have seen various bladder sling recalls by major manufacturers, such as:
- Boston Scientific
- Johnson & Johnson
- C.R Bard
Boston Scientific was the first to recall its vaginal mesh products in January 1999, when 500 lawsuits were filed. It also recalled another product in 2011 after discovering that the device could have a low tensile strength between the suture and needle, thus causing needle detachment when placing the leg of the mesh.
In 2012, Johnson & Johnson stated that it had stopped producing a series of vaginal mesh products due to the rising concerns over their safety.
Who Can File A Bladder Sling Injury Claim?
If you are one of the thousands of people who have experienced complications or adverse effects after bladder sling surgery, you may consider filing a claim. In order to qualify to file a claim for a bladder sling injury, you must prove at least one of the following conditions existed, leading to your injury:
- Defective Design: The bladder sling was defectively designed or manufactured, causing it to fail or lead to complications.
- Manufacturing Defects: In some cases, the device may not have been manufactured according to specifications, resulting in defective products causing harm.
- Failure to Warn: The manufacturer did not adequately warn patients or healthcare providers about the potential risks and side effects associated with the bladder sling.
- Medical Malpractice: The healthcare provider who performed the surgery was negligent in their duties, such as improperly placing the sling or failing to inform the patient about the risks involved.
- Negligence: If the medical practitioner did not perform the surgery according to acceptable standards, they might be found negligent.
It’s important to gather all relevant medical records, evidence of the defect or negligence, and consult with a personal injury attorney to evaluate the specifics of your case and guide you through the legal process of filing a bladder sling claim.
Steps to Take If You Experience Complications
Thousands of people experience complications after bladder sling surgery. IF you experience injuries or complications after bladder sling surgery, you should take the following steps:
- Seek Medical Attention: Immediately consult with your healthcare provider to address the complications. This may involve diagnostic tests, treatments, or even additional surgeries.
- Document Everything: Keep a detailed record of your symptoms, medical visits, treatments, and any adverse effects. This documentation will be critical for your medical care and any potential legal action.
- Obtain Medical Records: Collect all relevant medical records, including pre-surgery consultations, surgery details, post-operative care, and any follow-up treatments.
- Consult an Attorney: Consult with a lawyer who specializes in medical device injuries or product liability cases. They can provide legal advice, help determine if you have a viable claim, and guide you through the process of filing a lawsuit if appropriate.
- Notify the Manufacturer: Report your complications to the bladder sling manufacturer. They may have a process for handling such complaints and it contributes to the overall awareness of the product’s safety issues.
Taking these steps can help you to best protect your rights if you choose to file a bladder sling injury claim.
Ongoing Bladder Sling Lawsuits
More than 30,000 women have filed lawsuits against the manufacturers of transvaginal mesh devices after suffering from complications. A minimum of six manufacturers of these devices have been targeted by these cases as users believe that the alleged defects are not limited to a specific brand of implant.
Most of these lawsuits have been merged into multidistrict litigations under the guidance of Judge Godwin. This is the most favorable way of handling such product liability cases that involve complaints from a large number of people.
If you suffered from any of the listed complications resulting from using these vaginal mesh products, it’s important to talk to an experienced product liability lawyer as soon as possible. These types of lawsuits that involve many people are very complicated, and you should not risk handling them on your own. The way Multidistrict Litigations are handled is different from the ordinary personal injury cases, and you need an experienced head to guide you on the options that lie ahead.
Contact Cellino Law
If you or a loved one has been injured due to a bladder sling complication, don’t wait. Contact Cellino Law today. Our team has decades of experience fighting for injury victims, including those who have been injured by defective medical equipment like bladder slings.
We are ready to assist you with your claim and guide you through this challenging time. Reach out to us at 888-888-8888 to schedule your free consultation with a member of our legal team and take the first step towards securing the compensation you deserve.
Content checked by the personal injury attorney Ross Cellino. As a family man and a trial attorney, I pride myself on winning cases and serving the community. With over 35 years of experience, I understand the function of a jury, how juries arrive at conclusions, and the role that the jury plays in administering justice. I know how to win cases. You can find us in Manhattan, Buffalo, Melville, Rochester, Brooklyn, The Bronx, Queens and other locations throughout New York.