Transvaginal Mesh Failure Attorneys
The body is an amazing instrument, but sometimes it needs a little outside help to repair itself. When weak muscles, ligaments, and tissues can no longer support the weight of the organs they are meant to protect, they need a new support structure. That’s where transvaginal mesh comes into play. Manufacturers touted this device as a safe and effective treatment for certain conditions where the muscles can no longer handle the weight of holding up pelvic organs. Women suffering from painful medical conditions were given hope that this treatment would be the key to their recovery.
Unfortunately, the key to recovery turned into a medical nightmare for many women. Transvaginal mesh can create an entire host of serious side effects and dangerous medical complications. Manufacturers of the device raked in millions of dollars while women suffered from the mental, physical, and financial fallout of this defective device.
If you are one of the many women who have suffered from serious injuries or complications related to the use of transvaginal mesh, you may be entitled to compensation. Manufacturers may be held liable for their negligence and owe you money. The defective medical device attorneys at Farris, Riley & Pitt, LLP can help you recover this compensation while treating you with the respect and compassion we know you deserve right now. We understand that this can be a difficult topic to talk about. That is why we offer a free and completely confidential consultation.
Ready to talk about your experience with transvaginal mesh? Call Farris, Riley & Pitt, LLP today at (205) 324-1212, and we’ll set you up with a confidential consultation. We can evaluate your situation, what your case might be worth, and how we can help you go after the money you deserve.
Facts About Transvaginal Mesh
Mesh is a netting-like material that is typically made from plastic or synthetic materials such as polypropylene. Transvaginal refers to the surgical technique that physicians use to implant the mesh through the vagina. Mesh-like products were being used as early as the 1950s to help repair hernias, mostly in the abdominal cavity. By the 1990s, this technique was gaining a strong foothold with gynecologists for the treatment of certain bladder and pelvic conditions in women.
What is Transvaginal Mesh Used For?
Transvaginal mesh is used to treat two pelvic area conditions in particular. The first is stress urinary incontinence, also known as SUI. The FDA first cleared the use of transvaginal mesh for the treatment of SUI in 1996. Stress urinary incontinence is the unintentional expelling of urine from the body or urine leaking. This leaking is usually triggered by some sort of physical activity or stress on the bladder, such as intense exercise, laughing, sneezing, or coughing. Heavy lifting and sexual activity may also trigger SUI.
The condition is caused by weak pelvic floor muscles and surrounding tissues, which are meant to support the bladder and urethra. These muscles, ligaments, and tissues can become weak due to illness, obesity, age, and childbirth. In addition to the physical implications, this condition can also cause serious psychological issues as patients tend to feel embarrassed, isolated, and judged. Transvaginal mesh is used to treat SUI by lending additional support to the weakened pelvic floor muscles, taking some of the pressure off the bladder and urethra.
Additionally, transvaginal mesh was approved by the FDA for pelvic organ prolapse in 2002. Pelvic organ prolapse, or POP, is a painful condition that generally impacts women after childbirth and menopause. The pelvic muscles support and cradle internal organs like a hammock. When those muscles are weakened organs, such as the bladder, uterus, and rectum to can fall into the vagina.
There are different names for pelvic organ prolapse depending on which organs are impacted. The dropping of the bladder is called cystocele. The rectum falling into the vagina is rectocele, and a dropped uterus is known as uterine prolapse. A prolapse can be uncomfortable, painful and lead to an increase in infections and incontinence. It can also cause significant pain and discomfort when engaging in sexual intercourse. As with SUI, transvaginal mesh is meant to support the weakened muscles and also prevent the internal organs from dropping back down into the vagina.
Transvaginal Mesh Complications and Side Effects
Women suffering from the debilitating and often embarrassing side effects of SUI and POP trusted their doctors to recommend a treatment option to ease their suffering. Doctors trusted the information provided by pharmaceutical manufacturers stating that transvaginal mesh was a safe and effective treatment option for many forms of stress urinary incontinence and pelvic organ prolapse.
However, in the mid-to-late 2000s, the FDA began receiving an influx of complaints from both patients and physicians who had used or implanted transvaginal mesh. These complaints laid out a number of serious side effects and complications caused by the device, some of which include:
- Erosion of the device
- Internal scarring
- Nerve damage
- Organ perforation or punctured organs
- Neuro-muscular issues
- Painful intercourse
- Urinary problems
- Recurring of the prolapse
These side effects and complications can change a woman’s entire life and can result in severe scarring, pain, disfigurement, and sexual dysfunction. The New York Times estimates that ten million women worldwide have received transvaginal mesh implants. Roughly ten to fifteen percent of women have complained about some form of complication or side effect. The result: hundreds of thousands of women are suffering from what is, in some cases, irreversible damage because negligent manufacturers put profits before public safety.
FDA Complaints and Action
Hundreds of thousands of victims have complained of complications, injuries, and side effects associated with transvaginal mesh. The complaints became so serious that in 2016 the FDA decided to reclassify surgical mesh used for treating POP from a class II device to a class III device. The FDA stated that more clinical evidence was needed to establish the safety and effectiveness of mesh as a treatment for POP. A class III medical device is considered one of the riskiest types of medical devices.
However, the issues with transvaginal mesh continue, and finally, in 2019, the FDA issued a new order about the use of the device. The FDA ordered all manufacturers to stop selling and distributing surgical mesh products intended for the treatment of pelvic organ prolapse. In halting the production and sale of transvaginal mesh products, the federal government stated that many mesh manufacturers failed to reevaluate the safety of their transvaginal mesh devices.
Manufacturers of Transvaginal Mesh Products
Transvaginal mesh became a popular and profitable medical device for the treatment of SUI and POP. As a result, several different manufacturers jumped on the bandwagon to produce this surgical product. Most of the manufacturers are now facing severe backlash and lawsuits from the victims they injured. The companies that produced this type of mesh and may be responsible for your complications and side effects include:
- American Medical Systems
- Boston Scientific
- Caldera Medical
- Coloplast Corp.
- Cook Medical
- C.R. Bard, Inc.
- DIMA S.L.
- Johnson & Johnson
Compensation for Transvaginal Mesh Complications
The physical and emotional consequences of a transvaginal mesh complication are clear. What is equally as painful for many are the financial consequences of being a victim. In some situations, additional and unexpected surgeries are needed to remove the transvaginal mesh. Other surgeries may also be necessary to attempt to repair the damage caused by the device. These additional medical treatments can put a significant financial strain on victims and their families. Why should a victim be required to foot the bill for these medical expenses while manufacturers reap the benefits of negligence?
Victims injured by transvaginal mesh may have the legal right to seek compensation from manufacturers. That compensation may include:
- Current medical expenses
- Future medical expenses related to the injury
- Lost wages
- Loss of earning capacity
- Loss of consortium
- Mental anguish
- Pain and suffering
Although money for medical bills is typically top of mind, victims may also be able to collect compensation for the pain and suffering that they have undergone. Dealing with a serious medical diagnosis is difficult enough. Add on to that medical condition a series of even more severe and debilitating side effects and complications, and the physical and emotional strain can be enormous. The side effects can result in isolation, embarrassment, and even the loss of a spouse or partner due to sexual dysfunction or pain associated with intimacy. Negligent manufacturers may be liable for your emotional pain as well as your physical pain.
Talking to an experienced defective medical device attorney is the best way to determine if you can hold a manufacturer accountable and learn what your case could be worth. You may be owed considerable compensation. The team at Farris, Riley & Pitt, LLP can help you get it.
Contact Farris, Riley & Pitt, LLP Today About Your Case
Defective medical device cases can be intense and complex. That’s why it is important to put your case into the hands of an experienced legal team. At Farris, Riley & Pitt, LLP, our goal is to treat you with the compassion and dignity you deserve while we build a case aggressively targeting the negligent manufacturer that caused your injury.
Alabama puts a strict statute of limitations of two years on the time you have to file a lawsuit. Don’t miss out on your opportunity to hold a major medical device company accountable for its reckless actions. You deserve compensation, and we want to help you get it. Contact us today by calling (205) 324-1212. We will set you up with a free and confidential case evaluation to discuss your situation and what we can do to help.