The Use of Synthetic Mesh in Central and Apical Compartment Repair

A review article published in the Current Urology Reports Journal in June, 2012, describes the various methods used in the repair of central and apical compartment pelvic organ prolapse using synthetic mesh. This article details the FDA’s recommendations and concerns regarding the use of synthetic mesh in these particular procedures. Pelvic organ prolapse is a relatively common condition which affects women, particularly those who have gone through childbirth, menopause or surgery. When the muscles and tissue of the pelvic floor weaken the organs begin to drop down, causing discomfort and pain. Age increases the risk of developing pelvic organ prolapse, and because the muscle and tissue are already weakened, there is a high recurrence rate of POP after surgery.

This high recurrence rate when using traditional surgical procedures led to the use of synthetic meshes which have been used successfully in the repair of abdominal wall hernias for decades. Synthetic meshes are classified according to type, pore size and filament type and are believed to be less invasive with a more standardized approach to placement. The typical placement techniques include surgeon-fashioned patches and tension-free vaginal kits which can be trocar, anchor or suture-based. The first kits designed specifically for the treatment of apical compartment repair in POP cases used trocars—sharp-edged instruments inside a cylinder—which passed through the membrane which closes the “hole” in the pelvis. Such kits are marketed under such brand names as Gynecare, Anterior Prolift, Perigree and Avaulta.

Single-incision kits using needle drivers or self-fixating tips include brand names such as Pinnacle, Uphold and Elevate. Finally, the Procima kit is a single-incision, non-fixation system which is held in place for three weeks by a vaginal support device which is sewn into place during the surgical procedure. Mesh patches are typically used in single or multi-compartment repairs with the approach depending on the individual case and the surgeon.

Apical vaginal compartment repair is usually accomplished through abdominal sacrocolpopexy (ASC) although highly skilled surgeons have developed their own technique to address defects in the anterior and posterior compartments during ASC. ASC, typically performed on younger, sexually active patients, may be performed in three ways: open, laparoscopic or robotic surgery. Aside from the variation in approach, the ASC surgical procedure has remained largely unchanged. A permanent mesh graft is secured to the sacral promontory and vaginal cuff. Enteroceles are reduced using culdoplasty which reduces the chance of recurrence. The laparoscopic procedure is suitable for elderly patients as it results in decreased loss of blood and a shorter hospital stay.

ASC can lead to both intraoperative and postoperative complications; a study of 1,500 patients concluded that subsequent operations following mesh procedures occur more frequently following transvaginal mesh placement into the anterior compartment.  Smoking, sexual activity, mesh placement and age contribute to the risks associated with mesh surgery. A report released in 2008 by the FDA discussed potential complications associated with pelvic organ prolapse surgery using transvaginal mesh. This report was updated in 2011 at which time the FDA stated it was unclear whether there were any advantages in using mesh over more traditional methods and that complications from transvaginal mesh were not as rare as previously reported.

Further clinical studies were proposed, and mesh kits which had previously been classified as Class II were moved up to a Class III which required that manufacturers submit study design demonstrating mesh procedures were not inferior to native tissue repairs. Mesh used in ASC was specifically excluded as their safety and efficacy have been well-established. Supporters of the use of surgical mesh believe it is difficult to make comparisons as data comparing mesh and non-mesh procedures are not entered into a device database. Further, they attribute mesh complications to technical deficiencies and the lack of skilled surgeons, leading the authors to emphasize the fact that training for mesh placement should be increased.

Synthetic or Native Tissue--Which is Better in the Repair of Posterior Vaginal Wall Prolapse Repair?

Women who have undergone menopause, childbirth or surgery are at particular risk for developing pelvic organ prolapse. As women age, their risk increases with approximately 11% of women requiring pelvic organ prolapse surgery by the age of 80. A history of smoking, being overweight or a compromised immune system can all increase the risk of pelvic organ prolapse as well as the risk of recurrence following surgery. A Current Urology Reports Journal article published in June, 2012 assesses the risks and benefits of using synthetic mesh when repairing posterior vaginal wall prolapse.

As many as 30% of women who undergo this surgery will experience a recurrence of POP. In an effort to lower this number, the procedures for using grafts to expand native tissue have been updated and in the past ten years the use of synthetic mesh has become more common. Surgical mesh kits designed specifically to repair anterior, posterior and vaginal vault pelvic organ prolapse have been FDA approved, although there is not enough post-market manufacturer’s data to thoroughly evaluate results. The data reviewed in the article listed above comes from publicly available research.

The posterior compartment is traditionally repaired using a sort of “folding” and suturing of the connective tissues to restore normal anatomy which is compromised when those tissues lose their elasticity and the organs drop from their normal positions. This “traditional” type of surgery typically has few complications and recurrence rates are low. Anatomic surgery is generally reserved for women with stage 0-1 of prolapse severity although approximately 35% have stage II. When failure is defined as prolapse beyond the hymen, presence of symptoms or recurrence, posterior pelvic organ prolapse repair cure rates are at least 90%, with recurrence following traditional methods at 3%. When synthetic mesh is used, complication rates are almost 17% and recurrence rates range from 4.1-16.9%.

Patients presenting symptoms of pelvic organ prolapse may need multiple-compartment repair requiring either a total vaginal mesh or combination of anterior-posterior mesh. Most complications noted occurred following anterior compartment or total vaginal repair using synthetic mesh. The complications occurred during the surgery, from the operating room to recovery unit or post-op. Complications ranged from puncture to bleeding and infection during or immediately following surgery. Delayed complications included mesh extrusion, retraction, chronic pain and sexual dysfunction.

In 2008 the FDA issued a safety communication which they later updated in 2011 regarding complication related to transvaginal mesh. Additional information was collected using the FDA database known as MAUDE or Manufacturer and User Facility Device Experience. Voluntary reports of adverse events involving medical devices such as surgical mesh are entered into this database although the data is not sufficient to compare rates across devices. The updated communication in 2011 was based on an analysis of 3,000 complication reports submitted between 2008 and 2011 and concluded that complications from transvaginal mesh were “not rare.” Further, the FDA stated there was little evidence to support the use of synthetic mesh over more traditional methods in the repair of pelvic organ prolapse. Since that 2011 FDA communication, lawsuits against manufacturers of synthetic mesh are on the rise with close to 700 cases being filed.

The authors of the Current Urology Reports Journal article state that the post-market studies requested by the FDA will result in a higher level of safety and efficacy data being made available which will in turn allow a thorough assessment of the use of synthetic mesh in posterior POP repair. Based on current data, however, traditional methods involving native tissue appear to have similar outcomes to synthetic mesh used in the repair of posterior pelvic organ prolapse however synthetic mesh has a higher risk of complications. The standard treatment for posterior compartment POP will remain traditional, using native tissue for a positive outcome and few complications.

Update on Synthetic Mesh Used in the Repair of Anterior Pelvic Organ Prolapse

It is believed pelvic organ prolapse affects millions of women, however many women do not seek medical intervention due to the nature of the problem. Pelvic organ prolapse occurs when an organ within the pelvic region drops from its normal spot, pushing against the vaginal walls. Approximately 200,000 women will undergo a surgical procedure for pelvic organ prolapse annually. Of the women who undergo the procedure, at least 30 percent will require an additional prolapse repair procedure. Most women with pelvic organ prolapse experience discomfort and pain on a daily basis. Many will also be unable to exercise or engage in sexual relations.

Pelvic organ prolapse primarily occurs when the muscles holding the pelvic organs in place are weakened from childbirth or surgery. Women going through menopause and elderly women are also more likely to suffer from pelvic organ prolapse. When the pelvic muscles and connective tissues—which are largely comprised of collagen and elastin— are subject to repeated or severe strain, they will no longer hold the pelvic organs in place. Candidates for surgical repair of pelvic organ prolapse are generally women for whom conservative management has not offered significant relief. The type of surgical procedure will depend on the site of the prolapse, whether urinary incontinence is present, the overall health of the patient and the specific patient preferences.

An article published last June in the Current Urology Reports Journal reviews the use of synthetic mesh in the treatment of pelvic organ prolapse. Significant data supports mesh use for POP surgeries although the authors of the Journal article also note the risks involved in the use of transvaginalmesh. Fibroblasts—cells which are involved in the synthesis of the connective tissues—are responsible for a decrease in elastin and an increase in the enzyme which breaks down elastin. It is likely that the increased levels of this enzyme, elastase, probably plays a role in the high failure rates of pelvic organ prolapse surgeries which is estimated to be as high as 29%.

While native tissue was widely used prior to the introduction of synthetic mesh—and continues to be used in many cases—the use of native tissue can further break down connective tissues. Biological grafts also have the tendency to break down when placed in an environment known to break down those proteins. Because of this, the use of mesh seems to have a definite advantage over native tissue or biological grafts as they are—in theory at least—resistant to these protein breakdowns.

The authors consider the ideal graft, whether biological or synthetic, to be “sterile, inert, non-carcinogenic, durable, non-inflammatory, inexpensive, readily available and easy to use.” Mesh implants with larger pore sizes are believed to encourage tissue growth and prevent infections when compared with smaller pore mesh. The most common type of mesh used is made from polypropylene and classified as Type 1, macroporous. Type II mesh, Gore-Tex, is microporous which allows limited tissue growth. In turn, that limited tissue growth may lead to higher erosion and infection rates.

The FDA issued a warning regarding synthetic mesh in 2011; the authors of this study present data from four trials as well as summaries from an additional three trials which compare the repair of the anterior vaginal wall through colporrhaphy vs. the use of mesh. Colporrhaphy is a surgical procedure in which narrowing of the vagina is accomplished through the use of sutures. While the mesh procedures resulted in lower rates of anatomic failures, from 3.2-19% of those patients required treatment for vaginal extrusion. Mesh extrusion can result in painful intercourse, vaginal discharge, odor, pelvic pain and bleeding.

Although most extrusions can be treated in a doctor’s office, others require surgical intervention. The article concludes that while there is insufficient data to support the FDAwarning regarding pelvic pain and mesh contraction, the following improvements suggested by the FDA should be implemented: improved regulations, the careful selection of mesh patients, improvement in patient education, open discussions with patients regarding the risks and benefits of mesh treatment, deeper incisions to allow adequate vaginal tissue coverage and the appropriate training of physicians.

More Metal Hip Implant Troubles for Beleaguered Johnson & Johnson

Despite the fact that Johnson & Johnson is a well-known name in most households, they are currently laboring under yet another hit to their once squeaky-clean image. While most of us associate J & J with such things as baby products, the company is in fact one of the foremost manufacturers of medical devices. The first sign of trouble occurred when the DePuy (a subsidiary of J & J) ASR metal-on-metal hip implant was recalled in 2010 amidst a flurry of reports that the device was defective and responsible for literally thousands of injuries to recipients of the device. At present, some estimate that as many as 10,000 lawsuits have been filed since the recall of the ASR, the first of which is currently being tried in California.

Recalls and Lawsuits Plague Johnson & Johnson

Another all-metal hip implant manufactured by DePuy, the Pinnacle, while not yet recalled has had its own share of problems, leaving J & J to deal with yet another round of litigation.   Very recently yet another Johnson and Johnson hip implant, the Adept, was recalled from the overseas market, reportedly due to the high rate of failure. As if all these recalls and lawsuits over J & J and DePuy’s line of all-metal hip implants were not enough, on February 22, 2013, Johnson & Johnson was notified that the Justice Department and United States Attorney’s Office were looking into potentially suspect practices related to the marketing of DePuy’s metal hip implants.

The First ASR Trial Ongoing

The first ASR trial concerns Loren Kransky, a retired male, who suffered extremely serious side effects from the ASR all-metal hip implant. Although attorneys for Johnson & Johnson are arguing that Kransky’s health issues were due to a history of smoking as well as other pre-existing conditions, Kransky claims he suffered heavy metal poisoning as a result of the all-metal DePuy hip implant. Strong evidence in the case lends credence to the claims by Kransky that DePuy placed the ASR on the market despite being aware of specific safety hazards related to the all-metal implant.

Johnson & Johnson’s Public Image Tarnished

With over two dozen products recalled by Johnson & Johnson in the past few years, Johnson & Johnson’s public image has suffered not to mention their bank account. At the time the ASR was recalled, DePuy claimed it was recalling the implant due to a failure rate of approximately 12%. Bloomberg reports those numbers as being as high as 40%. Although there is currently no database in the United States which tracks hip implants, it is believed that as many as 90,000 ASR hip devices were implanted and recalled.    

The Pinnacle hip implant, although still being marketed, has been buffeted with lawsuits as well from those who claim they were harmed by the implant, whether from metal poisoning or inflammation, tissue death and bone loss leading to total implant failure. When the all-metal hip implants first appeared, they were believed to last from 10-20 years—considerably longer than their ceramic and polyethylene counterparts. Research shows, however, that one in eight patients implanted with an ASR will require revision surgery within five years of their original implant.

Legal Implications for Johnson & Johnson

The Adept recall is unlikely to have the same level of financial impact on Johnson & Johnson as the ongoing lawsuits for the ASR which have already racked up over $900 million dollars in legal fees and settlement fees. It is estimated there are less than 10,000 Adept hip devices implanted in patients overseas, meaning the liability will be much less for J & J. Johnson & Johnson is expected to take a much tougher stance when dealing with Pinnacle lawsuits as compared to the ASR settlements. Even so, surgeons are hesitant to recommend a Pinnacle implant considering the number of patients claiming they were harmed by the device.  Despite the recalls and lawsuits, Johnson & Johnson remains the largest manufacturer in the health care industry. The outcome of the Kransky trial will likely be a predictor of how the future cases will go, so plaintiffs and their attorneys are following the trial with interest.

$3.35 Million Dollar Award Considered a Victory for all Upcoming Mesh Cases

Linda Gross, a 47-year old hospice nurse from South Dakota was awarded $3.35 million dollars as a result of her lawsuit against Ethicon and Johnson & Johnson—the manufacturers of the Prolift vaginal mesh implant. This is the first trial of over 4,000—nearly half of which will take place in the same New Jersey court. In addition to the compensatory award, a second phase of the trial will allow jurors to consider punitive damages. Under New Jersey law, punitive damages of up to five times the compensatory damages are permitted. This first trial, Gross v. Ethicon, took over six weeks with five days of jury deliberation following closing arguments by both sides. Claims of defective design were rejected by the jury however the jury did find sufficient evidence of failure to warn physicians and patients of the potential harm as well as fraudulent representation.

Serious Harm Suffered as a Result of Ethicon’s Prolift Mesh Device

Of the $3.5 million award, $185,000 was awarded to Gross’s husband for loss of consortium with $680,000 as compensation for past and future wages due to Gross’s inability to work following the mesh implantation. The remainder of the jury award addressed household-help expenses, medical expenses, disability, impairment and pain and mental anguish. Following her implantation of the Prolift in 2005 as a treatment for pelvic organ prolapse, Gross claimed she suffered debilitating injuries.

Gross underwent 18 surgical procedures to correct complications from the Prolift, had over 400 doctor visits and currently takes over 20 daily medications to address the chronic pain she suffers. The mesh device hardened in Gross’s body leading her to characterize her life as a “living hell” when she testified. Gross stated she had suffered scar tissue formation, mesh erosion, chronic inflammation and neurologic compromise which had rendered her unable to engage in sex with her husband, unable to sit for even twenty minutes without experiencing excruciating pain, and unable to return to work.

How Ethicon Circumvented the FDA

The Prolift surgical mesh somehow evaded FDA approval prior to its being marketed in March, 2005. That evasion exposed thousands of women to serious complications after being implanted with Prolift. Ethicon withdrew the Prolift from the market in 2012, claiming the mesh implants lacked commercial practicality—with no mention of safety concerns. As opposed to the prior generation mesh, the Gynemesh PS, the Prolift comes pre-cut in a kit, however was comprised of a larger volume of mesh which had the potential to lead to greater inflammatory reactions. Further, the “arms” of the Prolift were put in locations which would be both difficult and dangerous to access should complications arise.

Because there was technically no “substantially similar” product on the market at the time the Prolift became available, the FDA’s 510(k) process was not deemed the appropriate process. Medical devices which are significantly different than their predecessors require classification by the FDA as well as time-consuming and expensive pre-market application. These rules are meant to assure the safety and performance of a medical device, evaluating all potential risks to patients. A representative of Ethicon claimed the changes made to the Prolift were not significant enough to warrant 510(k) approval.

FDA Approval—Three Years after Prolift Marketing Began

When the FDA realized the approval omission—nearly three years after the device had been marketed and implanted in thousands of women—they granted approval to Ethicon. The instructions for use, patient brochure and website for the Prolift all failed to warn of potential complications of the mesh product. Further, nothing warned that surgeons implanting the device could need special training.

A Victory for Other Plaintiffs

Lawyers and their clients who have currently filed suit against Ethicon and Johnson & Johnson believe this verdict to be a victory for their own upcoming cases. Thousands of women suffered serious complications and harm from the Prolift because of Ethicon’s rush to get Prolift to market and increase company revenues.