Pelvic Mesh And Medical Malpractice

Pelvic mesh, also called transvaginal mesh, is a net-like medical implant that is commonly used to treat pelvic organ prolapse and stress urinary incontinence. The surgical mesh provides support when repairing weakened or damaged tissue. However, many patients complain of chronic pain, discomfort, and incontinence after having surgery with pelvic mesh. Thousands of patients have filed lawsuits against the pelvic mesh manufacturers seeking damages for their injuries.

History of Pelvic Mesh

Surgical mesh has a long history in the United States. Surgical mesh has been used since the 1950s in treating hernias to repair tears in the abdominal wall. Since about the 1970s, doctors and gynecologists began using surgical mesh indicated for hernia repair to treat transvaginal repairs of pelvic organ prolapse and treat stress urinary incontinence. Medical device manufacturers then developed mesh products specifically designed for pelvic procedures.

Surgical mesh can be made of absorbable or non-absorbable materials. This includes:

• non-absorbable synthetic (such as polypropylene or polyester)
• absorbable synthetic (such as polylactic-co-glycolic acid or polycaprolactone)
• biologic (such as acellular collagen derived from cow or pig sources)
• composite (a combination of the above categories)

Most pelvic surgical mesh is made from non-absorbable synthetic polypropylene.

FDA Approval of Pelvic Mesh

In 1996, the Food and Drug Administration (FDA) approved the first surgical mesh product for use in the treatment of stress urinary incontinence (SUI). In 2002, the FDA cleared the first surgical mesh product specifically for use in the treatment of pelvic organ prolapse (POP).

Pelvic mesh products are regulated as Class II devices. The FDA’s premarket review of surgical mesh primarily focused on mechanical performance and material safety information. Testing has been used to confirm engineering specifications and that pelvic mesh is biocompatible. However, clinical tests are generally not used in getting approval for Class II medical devices, like pelvic mesh.

On October 20, 2008, the FDA issued a Public Health Notification to healthcare professionals warning of the safety risks involved in using pelvic mesh in SUI and POP surgeries. Between 2005 and 2007, the FDA received more than 1,000 reports of complications related to pelvic mesh.

On May 1, 2014, the FDA proposed reclassifying pelvic mesh from a Class II medical device to a Class III medical device because of safety risks. Surgical tools used in pelvic mesh surgeries were also proposed to have an increase in class level.

On January 4, 2016, the FDA reclassified pelvic mesh as a Class III medical device, the highest risk level for medical devices. As a Class III medical device, new pelvic mesh products will require premarket approval (PMA) by the FDA. “This requires manufacturers to address safety concerns, including severe pelvic pain and organ perforation, through a rigorous PMA pathway to demonstrate safety and effectiveness.”

The Intended Use of Pelvic Mesh

Pelvic mesh is primarily used for urogynecological procedures to repair stress urinary incontinence and pelvic organ prolapse. Pelvic mesh is a polymeric screen that is implanted in order to reinforce weaknesses in soft tissue.

Pelvic Organ Prolapse

Pelvic organ prolapse is a condition affecting women where the tissue and muscles of the pelvic floor cannot support the pelvic organs, leading to a prolapse of the pelvic organs. The pelvic organs include the uterus, bladder, urethra, rectum, vagina, and cervix. Pelvic organ prolapse most commonly affects the bladder.

Millions of women in the U.S. have some degree of POP. It is especially common in women who have had vaginal births. Supporting pelvic floor muscle and tissue can become stretched due to labor or childbirth. Over time, pelvic muscle and tissue may weaken, and becomes more common in women who reach menopause. Obesity, constipation, connective tissue disorder, and genetic predisposition are other risk factors for POP.

The lifetime risk of a woman having POP is between 30 and 50 percent. However, the estimated risk of symptomatic POP is about 2%. Symptomatic POP can be managed by pelvic floor exercises, vaginal inserts, or surgical operations with or without surgical mesh.

Patients with POP have a number of possible symptoms. In some cases, patients with POP do not suffer any symptoms. Symptoms of POP include:

• Pelvic discomfort
• Pain
• Pressure
• Bulge of tissue or organs that protrude past the vaginal opening
• Urinary incontinence
• Sexual difficulties

Pelvic mesh may be used in surgery for individuals with POP. Patients may undergo surgery to implant pelvic mesh to treat serious pain or discomfort associated with POP. Before considering surgery, patients should talk to their healthcare provider and consider a number of factors, including:

• Which organ or organs have prolapsed
• Severity of prolapse
• Desire to have children
• Age and health
• Sexual activity
• Seriousness of symptoms

Surgery to repair POP may involve making an incision in the abdomen or through the vagina, using surgical mesh to keep the pelvic organs in place.

Stress Urinary Incontinence

Stress urinary incontinence involves leakage of urine related to increases in abdominal pressure. This can include urinary leakage related to coughing, laughing, exercise, or sneezing.

Like POP, SUI generally occurs when pelvic tissues and muscles become weakened over time. The weakened muscles and tissue that support the bladder allow the neck of the bladder to descend during moments of physical activity. This can prevent the urethra from controlling the flow of urine, leading to leakage. Tissue weakness may occur over time, related to pregnancy, childbirth, or pelvic surgery. Other risk factors include chronic coughing, obesity, and smoking.

Pelvic mesh may be used in surgery for individuals with SUI. Before considering surgery, patients should talk to their healthcare provider and consider a number of factors, including:

• The severity of SUI symptoms
• How SUI symptoms affect your daily activities
• Desire for future pregnancy

Surgery to decrease urine leakage may involve making an incision in the abdomen or through the vagina. A surgical mesh sling may be used to support the urethra or bladder neck. During a “sling procedure,” the mesh is permanently implanted to support the urethra or neck bladder to correct SUI.

Using mesh in SUI surgery may be less invasive than non-mesh surgical repair, which may require a larger incision. Sling procedures may involve multiple incisions (one vaginal incision and two lower abdominal incision or one vaginal incision and two groin/thigh incisions); or a single incision that uses a shorter piece of pelvic mesh.

Pelvic Mesh Manufacturers

There are a number of pelvic mesh manufacturers. These companies often have a number of pelvic mesh products and kits on the market at any given time. Some of these manufacturers have ceased production of their pelvic mesh products or taken the device off the market. Pelvic mesh manufacturers include:

• American Medical Systems
• Boston Scientific
• Coloplast
• Covidien
• C.R. Bard
• Ethicon (Johnson & Johnson)
• Sofradim
• Tyco

Adverse Events Involving Pelvic Mesh

The FDA maintains a database of medical device reports of adverse events reported. From 2005 to 2010, a search of the adverse events database identified 3,979 reports of injury, death, or malfunction involving pelvic mesh.

The most frequent complications reported from the use of pelvic mesh for POP procedures included:

• Pain
• Vaginal mesh erosion
• Mesh extrusion or protrusion
• Pelvic mesh exposure
• Dyspareunia (painful sexual intercourse)
• Infection
• Urinary problems
• Bleeding
• Organ Perforation
• Recurrent prolapse
• Neuro-muscular problems
• Vaginal scarring
• Vaginal shrinkage
• Emotional problems

Complications from Using Pelvic Mesh

Many of the painful complications involving painful mesh required additional medical intervention. This included drug treatment, surgery, hospitalization, or other medical treatment.

Revision surgery post-pelvic mesh complications can be difficult to perform and require additional surgical procedures. Mesh that is not absorbable by the body will stay in the patient indefinitely. The only way to remove pelvic mesh after insertion is through surgery. However, pelvic mesh that breaks apart or erodes can be difficult to extract. Tissue grows around the mesh, which may require multiple procedures to remove the mesh, at risk of leaving small pieces of mesh behind.

Any surgery involves risks, even in healthy patients. The more surgical procedures involved, the greater the risk of injury or death to the patient. This includes a risk of internal bleeding, reactions to anesthesia, and infection. Many patients who undergo pelvic mesh surgery require additional surgeries to address pain or other complications. In some cases, this requires multiple follow-up surgeries. In the end, the additional surgical procedures may not be able to address all the symptoms of defective pelvic mesh surgery.

Deaths from Pelvic Mesh

Between 2008 and 2010, there were seven deaths reported associated with pelvic organ prolapse surgery. Three of those deaths were related to the surgical placement of the mesh, including two bowel perforations and one death from hemorrhage. Four other deaths were related to postoperative medical complications that could not directly be linked to pelvic mesh.

FDA Patient Recommendations

The FDA makes a number of recommendations for patients considering POP surgery. Prior to surgery, patients should be aware of the risks associated with POP repair. Having a mesh surgery may increase the risk for additional surgical procedures because of pelvic mesh-related complications. Patients should talk to their doctor about all POP treatment options, including surgical repair without mesh and non-surgical options.

Patients who have already undergone POP surgery with pelvic mesh should continue their regular check-ups and follow-up care. Patients should notify their doctor if they develop symptoms or complications, including vaginal bleeding or discharge, pelvic or groin pain, or pain during sex.

Academic Review and Clinical Studies

FDA Review of Medical Literature

After the concerns of reported injuries and complications involving pelvic mesh, the FDA has been evaluating peer-reviewed scientific literature on the safety of pelvic mesh in POP and SUI operations. The FDA has identified a number of safety concerns involving pelvic mesh for POP procedures, including:

• Patients who undergo POP repair with mesh are subject to mesh-related complications that are not experienced by patients who undergo traditional surgery without mesh.
• Adverse events associated with transvaginally placed mesh can be life-altering for some women.
• Pain and other complications may continue even after mesh removal.
• Mesh-associated complications are not rare. The most common mesh-related complication experienced by patients undergoing transvaginal POP repair with mesh is vaginal mesh erosion.
• Based on data from 110 studies, approximately 10 percent of women undergoing transvaginal POP repair with mesh experienced mesh erosion within 12 months of surgery.
• More than half of the women who experienced erosion from non-absorbable synthetic mesh required surgical excision in the operating room. Some women required two to three additional surgeries.
• Mesh contraction, causing vaginal shortening, tightening, and/or vaginal pain in association with transvaginal POP repair with mesh is increasingly reported in the literature.
• New onset SUI has been reported to occur more frequently following mesh augmented anterior repair compared to traditional anterior repair without mesh.
• Transvaginal surgery with mesh to correct vaginal apical prolapse is associated with a higher rate of complication requiring reoperation and reoperation for any reason compared to traditional vaginal surgery or sacral colpopexy.
• Abdominal POP surgery using mesh (sacral colpopexy) appears to result in lower rates of mesh complications compared to transvaginal POP surgery with mesh, with the median vaginal mesh erosion rate reported at 4 percent within 23 months of surgery.
• While transvaginal POP repair with mesh often restores anatomy, it has not been shown to improve clinical benefit over traditional non-mesh repair.

The Perils of Commercially Driven Surgical Innovation

In a January 2010 issue of the American Journal of Obstetrics & Gynecology, the authors of an article noted the safety concerns related to rushing the mesh surgical kits to market for commercial reasons. (The Perils of Commercially Driven Surgical Innovation, by L. Lewis Wall, MD, DPhil and Douglas Brown, PhD.)

“The practice of gynecological surgery is being reshaped by commercial interests that are promoting the use of trochar-and-mesh surgical kits for the treatment of stress incontinence and pelvic organ prolapse. In this article, we review the recent history of these surgical innovations and discuss the implications of changes in surgical practice that are driven by commercial interests of this kind. We situate this phenomenon within the general “lifecycle” of surgical innovation and point out the dangers inherent in the adoption of new procedures without adequate evidence to support their safety and efficacy. We highlight the ethical responsibilities surgeons and their professional organizations have in making sure such innovations are safe and effective before they come into widespread use.”

Pelvic Mesh Warnings and Recall Notices

On July 13, 2011, the FDA issued an “UPDATE on Serious Complications Associated with Transvaginal Placement of Surgical Mesh for Pelvic Organ Prolapse.” The communication was issued to inform the medical community and patients that:

1. Serious complications associated with surgical mesh for transvaginal repair of POP are not rare; and
2. It is not clear that transvaginal POP repair with mesh is more effective than traditional non-mesh repair.

Boston Scientific’s ProteGen Mesh Recall

In 1999, Boston Scientific’s ProteGen sling pelvic mesh product was recalled. Boston Scientific recalled the ProteGen because of “a higher than expected rate of vaginal erosion and dehiscence,” and the product “does not appear to function as intended. Boston Scientific recalled the product after numerous complaints of pain, injury, and infections.

Mentor ObTape Vaginal Sling Discontinued

In 2007, the company Mentor discontinued their vaginal sling device, the OpTape.

C.R. Bard Transvaginal Mesh Products Discontinued

C.R. Bard has taken three transvaginal mesh products off the market. These include Avaulta Plus; Pelvilance; and Uretex.

Johnson & Johnson Mesh Products

In 2012, Johnson & Johnson subsidiary Ethicon took four surgical mesh products off the market. This included: Gynecare Prolift Kit; Gynecare Prolift + M Kit; Gynecare TVT Secur; and Gynecare Prosima Pelvic Floor Repair System Kit.

Patients Legal Rights

There are many ways that medical devices and medical products may be considered defective. This could include a design defect where the product is not safe for the intended use. It may involve a failure to warn defect where the manufacturer failed to properly warn the patient about dangers involved with using the medical device.

Patients who are injured by defective medical products may be able to seek damages from the manufacturing company. Damages can include medical costs, income loss, and pain and suffering. Individuals who lose a loved one because of a defect may be able to file a wrongful death claim against the medical device manufacturing company.

Current Pelvic Mesh Cases

More than 100,000 lawsuits have been filed against medical device companies involving pelvic mesh. A number of these lawsuits are ongoing cases consolidated as class-action lawsuits. Others have reached multimillion-dollar verdicts for patients and their families. Many of these lawsuits are settled with the pelvic mesh companies for undisclosed amounts. Current pelvic mesh cases involve Johnson & Johnson, C.R. Bard, Boston Scientific, and others.

Pelvic Mesh Verdicts

Johnson & Johnson faces thousands of lawsuits related to pelvic mesh implants. Johnson & Johnson has settled multiple lawsuits while others were taken to trial resulting in verdicts for the plaintiffs and their families. Verdicts against the company have included:

• $20 million to a woman who suffered pain related to the TVT-Secur pelvic mesh product;
• $13.5 million was awarded to a woman in 2016 who suffered pain and discomfort related to transvaginal tape;
• $4.4 million to a woman in 2016 who suffered back pain, bladder pain, and problems urinating related to surgery involving the ObTape sling;
• $12.5 million to a patient who suffered pain, incontinence, and sexual difficulties related to the Prolift mesh device;
• $5.7 million to a woman who was implanted with the TVT Abbrevo leading to severe pain; and
• Multiple confidential settlements involving more than 100 pelvic mesh patients who suffered pain, and sexual difficulties related to pelvic mesh products.

Boston Scientific has settled multiple lawsuits for hundreds of millions of dollars. However, the company also went to trial on a number of early pelvic mesh cases. Verdicts against the company have included:

• $14.3 million to three plaintiffs in a West Virginia case in 2016;
• $100 million was awarded to a woman in 2015, which was later reduced to $10 million by the judge;
• $18.5 million to four women who suffered infections, nerve damage, and pain during sex. The plaintiffs each received between $3.25 and $4.25 million each;
• $26.7 million to four women who suffered pain, bleeding, and infections from pelvic mesh; and
• $73 million to plaintiff Martha Salazar in September 2014, which was later reduced to 34.5 million by the judge.

Endo International has agreed to settle thousands of pelvic mesh lawsuits. Endo has agreed to pay almost $1.6 billion to settle most of the pelvic mesh injury cases. Endo has settled more than 30,000 cases and has since stopped making pelvic mesh products.

C.R. Bard has agreed to settle a number of pelvic mesh cases. In 2015, C.R. Bard settled almost 3,000 transvaginal mesh cases for more than $200 million. In 2014, C.R. Bard agreed to pay out more than $21 million to settle another about 500 pelvic mesh cases.

In 2012, a jury verdict was returned for a plaintiff who had C.R. Bard’s Avaulta Plus mesh implant leading to additional surgeries and pelvic pain. The jury returned an award of $5.5 million, which was later reduced to $3.6 million.

In 2013, a plaintiff who suffered pelvic pain, bleeding, and bladder problems won a verdict against C.R. Bard for a pelvic organ prolapse mesh implant. The jury returned a verdict for the plaintiff for $2 million.

Pelvic mesh manufacturer Coloplast has settled hundreds of pelvic mesh lawsuits for $16 million. The Danish medical device maker was involved in a lawsuit with approximately 400 plaintiffs, who will receive an average payout of about $40,000.

The parties in Neomedic multidistrict litigation involving pelvic mesh reached a $2.19 million settlement in December 2015. At issue were a number of sling mesh systems, including the Contasure Needleless Sling System, the Uplift device, and the Surelift device. The settlement involves an undisclosed number of plaintiffs.

Medtronic Inc. has purchased Covidien PLC, which was involved in more than 11,000 pelvic mesh lawsuits. Two Covidien units supplied C.R. Bard with mesh products which may be subject to a number of lawsuits. Medtronic has put $180 million aside to settle an undisclosed number of pelvic mesh lawsuits.

Pelvic Mesh Defect Lawyers Gilman & Bedigian

If you were injured after a pelvic mesh surgical treatment or have pain related to pelvic mesh in your body, you may have a legal claim for medical bills, lost wages, and other damages. If a loved one died as the result of a pelvic mesh infection, you should talk to experienced drug defect attorneys about your claim. You should not have to suffer due to the medical device company’s negligence.

At Gilman & Bedigian, we will use our experience, knowledge, and dedication to fight for you to receive the compensation you and your family deserve. Our aggressive trial lawyers have helped our clients recover millions of dollars in compensation related to defective medical devices and defective drug injuries. Contact us online or call our law office at (800) 529-6162 for a free consultation.