Johnson & Johnson Prolift Mesh Kits

Gynecare Prolift System

Johnson & Johnson Prolift Mesh Kits have become a focal point of intense scrutiny due to reports of severe complications and later legal actions. This article explores the history, medical concerns, and ongoing legal ramifications associated with these controversial products. This article seeks to help you understand the facts and figures that have shaped public and medical opinion about Prolift Mesh Kits without the fluff.

Key Takeaways

  • Johnson & Johnson’s Prolift transvaginal mesh, intended to treat Pelvic Organ Prolapse (POP), is under scrutiny due to many complications such as erosion, pain, and need for follow-up surgeries.
  • There have been significant legal repercussions for manufacturers of transvaginal mesh kits, including Johnson & Johnson, illustrated by substantial financial settlements and court rulings acknowledging the concealment of product risks.
  • Amidst the controversy, alternative non-surgical and surgical treatment options for POP and stress urinary incontinence are available, which carry fewer risks compared to transvaginal mesh implants.

Johnson & Johnson Prolift Mesh KitsJohnson & Johnson’s Prolift Mesh Kits: Background and Purpose

For many women, Pelvic Organ Prolapse (POP), or the descent of the vaginal apex due to weakened support structures, poses a significant issue. Johnson & Johnson crafted the Prolift Mesh Kits as a surgical response specifically tailored to treat apical vaginal prolapse.

Vaginal mesh kits include vaginal mesh implants, also known as transvaginal mesh or pelvic mesh, intended to support the pelvic organs and alleviate the symptoms of POP.

The Role of Transvaginal Mesh in POP Treatment

Transvaginal mesh, the primary component of the Prolift kits, is a medical device used in the surgical treatment of POP. Placement of the mesh can be either abdominally or transvaginally, with safety and effectiveness favoring the abdominal approach. J&J claimed fewer instances of recurrent prolapse result from transvaginal mesh placement, thus making it a suitable choice for certain patients. But evidence to date suggests that is not the case.

 

Gynecare Prolift System

Johnson & Johnson’s Gynecare Prolift System

The Gynecare Prolift System, a product developed by Ethicon Women’s Health and Urology (a subsidiary of Johnson & Johnson), is the mainstay of the Prolift Mesh Kits. The system has been shown to have a relatively high objective success rate in the treatment of apical vaginal prolapse, marking it as an effective solution for the condition. However, the mesh’s effectiveness is not without its controversies as functionally women are frequently worse off after the Prolift mesh is implanted because of pain.

The Controversy Surrounding Transvaginal Mesh Products

Controversies have arisen regarding the use of transvaginal mesh products, including Johnson & Johnson’s Prolift Mesh Kits. Women who have undergone surgery involving these mesh kits have reported several complications, including:

  • bleeding
  • pelvic pain
  • painful intercourse
  • erosion of the vaginal wall

The long-term data on the products paints an even grimmer picture, as they fail to prove themselves as substantially equivalent to their competitors.

For women implanted with certain mesh slings, up to 42% of patients have experienced at least one adverse event, including adverse reactions, with 12% suffering serious adverse events, including issues appearing several years post-surgery. [1]

Mesh Erosion and Painful Sex

One of the primary complications associated with the use of surgical mesh is mesh erosion, a condition where the mesh pokes through the vaginal wall, leading to vaginal scarring, fistula

formation, and pelvic, back, and leg pains. An early study on Prolift had to be stopped because over 15% of women implanted with Prolift had mesh erosions. Iglesia, Vaginal Mesh for Prolapse, Vol 116, Obstetrics and Gynecology, 293 (2010).

The mesh erosion can also lead to pain during intercourse, significantly compromising sexual function and diminishing the quality of life.

High Risk of Complications and Revisions

Transvaginal mesh products, including the Prolift Mesh Kits, are associated with a high risk of complications. Often, these complications require more surgeries, including mesh removal or trimming of the exposed mesh. Studies indicate that between 2.3% and 6.1% of women may need medical intervention for mesh complications, and 1.4% to 3.3% might require mesh removal after 1 to 9 years post mid-urethral sling placement. [1]

One of the most severe complications is organ perforation, with bladder perforation occurring seven times more often in women with mesh repairs than in non-mesh colporrhaphy procedures.

 

Pelvic pain after mesh surgery

Legal Battles and FDA Actions

The complications associated with transvaginal mesh have not only led to physical and emotional suffering for patients but have also sparked legal battles involving companies like Boston Scientific. In 2023, the California Court of Appeals upheld a $302 million judgment against Johnson & Johnson for concealing the risks of its mesh products. People v. Johnson & Johnson, 77 Cal.App.5th 295, 342 (Cal. Ct. App. 2022)

An earlier wave of litigation in 2017 saw women who sued mesh manufacturers win at least 20 verdicts in state and federal courts totaling around $300 million.  In a 2018 case, Tom Plouff from Chicago, of Plouff Law Offices, obtained a $35 million jury verdict in Hammond, IN on behalf of a woman injured by Prolift. Kaiser v. Johnson & Johnson, 947 F.3d 996, 1005 (7th Cir. 2020)

FDA Orders and Safety Warnings

The FDA has been closely watching the situation with transvaginal mesh products. In 2019, it ordered the halt of sales and distribution of these devices in the United States due to safety concerns. This was in line with the FDA’s decision to reclassify transvaginal mesh for pelvic organ prolapse as a high-risk device back in 2016.

After a 36-month post-market surveillance study, the FDA reaffirmed in 2022 that the risks associated with the use of surgical mesh for transvaginal pelvic organ prolapse repair outweighed the supposed benefits.

Alternative Treatments for Pelvic Organ Prolapse and Stress Urinary Incontinence

In light of these controversies and risks associated with transvaginal mesh products, it’s important to consider alternative treatments for pelvic organ prolapse and stress urinary incontinence. Non-surgical options such as:

  • lifestyle changes, including weight management and avoiding activities that cause strain
  • the use of pessaries
  • pelvic floor muscle exercises
  • biofeedback
  • electrical stimulation

can help manage symptoms.

Non-Surgical Options

Among non-surgical treatments, options like avoiding standing for long periods, heavy lifting, and maintaining a high fiber diet can help manage symptoms of POP. Pelvic floor muscle training, commonly known as Kegels, is recommended to improve pelvic support and can be part of pelvic muscle rehabilitation, which may also include biofeedback therapy, vaginal weight training, and treat pop as an alternative for pelvic floor stimulation.

Pessaries, small devices made of plastic or silicone, are inserted into the vagina to support the uterus or vaginal walls, providing temporary or permanent relief.

 

pelvic organ prolapse Non-Surgical Options

Alternative Surgical Procedures

When non-surgical options are not sufficient, there are several alternative surgical procedures that can be considered:

  • Sacrospinous fixation: used to treat pelvic organ prolapse by attaching the vaginal vault to the sacrospinous ligament for added support.
  • Uterosacral ligament suspension: used to reattach prolapsed organs to the uterosacral ligaments, restoring the positions of the vagina and uterus.
  • Colpocleisis: a procedure that involves closing the vaginal opening to treat prolapse.
  • Robotic-assisted laparoscopic sacrocolpopexy: a minimally invasive procedure that uses robotic technology to attach the vagina to the sacrum for support.
  • Burch colposuspension: a procedure that involves attaching the bladder neck to the pubic bone to treat stress urinary incontinence.
  • Autologous sling surgery: a procedure that uses the patient’s own tissue to create a sling to support the urethra and treat stress urinary incontinence.
  • Mid-urethral sling procedures: a minimally invasive procedure that involves placing a synthetic sling under the urethra to treat stress urinary incontinence.

These surgical procedures can provide effective treatment options for pelvic organ prolapse and urinary incontinence.

Patients’ Experiences and Outcomes

Patients with mid-urethral slings, including those using Prolift mesh kits, most commonly suffer from complications like mesh exposure and pain, which gravely impact their sexual function and quality of life. Symptoms such as spotting, discharge, or discomfort during sex can indicate mesh-related complications.

Surgeons’ Perspectives on Transvaginal Mesh Use

Contrarily, surgeons have raised concerns about transvaginal mesh due to the potential quality of life impairing complications and possible need for subsequent surgeries. Expert surgeons suggest the following:

  • Lower complication rates are associated with surgeries performed in specialized centers.
  • Individualized treatment should be emphasized.
  • Mesh should be avoided in patients with risk factors such as diabetes and heavy smoking.

With conditions such as apical compartment prolapse, surgeons commonly prefer abdominal or laparoscopic repair with mesh over standard vaginal surgery, attributed to its safer procedures and more positive functional outcomes for the internal tissue.

transvaginal mesh lawsuit

 

Summary

The use of transvaginal mesh products, particularly Johnson & Johnson’s Prolift Mesh Kits, has been met with a wave of controversy due to serious complications and legal battles. While these products have shown effectiveness in treating conditions such as Pelvic Organ Prolapse, the associated risks and adverse reactions have led to a more cautious approach by surgeons and the banning of these devices by regulatory bodies like the FDA. However, it’s important to remember that alternatives exist, both surgical and non-surgical, providing hope to those affected by POP and stress urinary incontinence.

If you believe you have been harmed by the implant of mesh, you are encouraged to contact an experienced mesh attorney like Tom Plouff in Chicago, of Plouff Law Offices, PC, to discuss if you have any remedy available.

Frequently Asked Questions

What is the average settlement for a pelvic mesh lawsuit?

As of February 2024, average vaginal mesh settlement amounts have ranged from $40,000 to $450,000. Plaintiffs who have taken their cases to trial have received millions in jury verdicts, but some of these verdicts have been overturned or reduced.  https://www.drugwatch.com/transvaginal-mesh/verdict-settlement (As of 2/13/2024).  For example, in Kaiser v Johnson & Johnson, the jury verdict was for $10 million in compensatory damages and $25 million in punitive damages.  The trial judge reduced the punitive damages verdict from $25 million to $10 million and left intact the $10 million in compensatory damages.  According to attorney Tom Plouff of Chicago, a lead trial attorney in the case, the reduction of punitive damages helped with the appeal in which the Seventh Circuit upheld the $20 million verdict against Johnson & Johnson in the Prolift case, one of the highest ever awards for transvaginal mesh complications.

How much is the mesh implant payout?

Settlement amounts for mesh implant lawsuits can vary widely and are not publicly available. However, when speaking with an experienced mesh attorney like Tom Plouff from Chicago, you can be advised at some point during the litigation what the likely settlement amount for a case would be.

Who manufactures Prolift mesh?

The manufacturer of Prolift mesh is Johnson & Johnson. They were responsible for producing the defective product that caused issues for many women.

Is mesh still being used in prolapse surgery?

Surgical mesh for transvaginal repair of pelvic organ prolapse has been halted by the FDA due to complications such as mesh poking through the vaginal wall and pelvic pain, so this procedure is no longer done in the U.S.

What is the purpose of Johnson & Johnson’s Prolift Mesh Kits?

The purpose of Johnson & Johnson’s Prolift Mesh Kits is to surgically solve treating apical vaginal prolapse by addressing weakened support structures that cause the condition.

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