Public Citizen Fighting the Good Fight for Consumers
On August 25, 2011, Public Citizen, a consumer safety organization founded by Ralph Nader decades ago, submitted a Consumer Petition to the Food & Drug Administration seeking a ban of transvaginal surgical mesh products that are utilized in surgeries to repair pelvic organ prolapse. The petition was signed by Dr. Michael Carome, Deputy Director, and Dr. Sidney Wolfe, Director, of Public Citizen’s Health Research Group and Dr. Daniel Elliott, Assistant Professor of Urology, College of Medicine, and Mayo Clinic.
Pelvic organ prolapse is a common condition in women that occurs due to weakness in the tissues and muscles that support the bladder, uterus, and bowel. There are a number of conservative as well as surgical treatments for these conditions (such as anterior or posterior colporrhaphy) that do not involve the implantation of a foreign body. Most of the products that are being questioned are manufactured with non-absorbable synthetic polypropylene; a product that many physicians mistakenly believe (based upon representations by device manufacturers and outdated science) is inert once placed into the body.
The petition indicates that nearly 300,000 surgeries for pelvic organ prolapse were performed in 2010 in the United States, and that 70,000 of these surgeries utilized a transvaginal surgical mesh or sling product. This statistic is particularly troubling since the FDA first sounded the alarm about potential safety issues with this entire class of devices in 2008, yet very few patients and surgeons seem aware. The FDA’s alert on October 20, 2008, came many years after others first raised the very questionable safety record, troubling regulatory approval history, and scant data to support efficacy for these products. An analysis of adverse event reports by the FDA from 2005 through 2008 indicated that the Agency had received more than 1,000 reports of complications associated with use of transvaginal mesh in surgeries in patients who had experienced pelvic organ prolapse or urinary incontinence. A July 13, 2011, revised safety alert from the FDA indicated that the MAUDE database utilized by the Agency for adverse event reports included nearly 4,000 reports of injury, death or device malfunctions between 2005 and 2010, with the number of new AER reports growing exponentially (a 500% increase) over the past few years.
In urging a recall of the products, Public Citizen reviews the scientific literature that has been published since the products were first introduced in the United States many years ago. Some studies show that patients tend to have less recurrence of pelvic organ prolapse after placement of the synthetic polypropylene devices; however, those findings alone do not justify use of these unsafe products. Most of the published scientific studies had limitations in their persuasiveness, especially since they were short-term studies, involved a limited number of patients, did not include controls, were not “blinded” to avoid bias, were not designed to evaluate safety issues, etc. The published medical literature also shows that patients who have been implanted with transvaginal surgical mesh are suffering a number of complications, most of which are not associated with other surgical and non-surgical treatment options for pelvic organ prolapse. These serious side effects associated with the mesh products include: mesh erosion through the vaginal wall in 5% to 19% of patients; development of urinary incontinence; bladder perforations; pelvic hematomas; significant blood loss and post-operative complications; chronic infections; sexual dysfunction; scarring, tightening, and shrinkage of the vagina; chronic pain; urogenital fistulae formation; and the need for multiple additional surgical procedures due to mesh-related complications.
The transvaginal mesh products targeted by this Consumer Petition have been subject to litigation efforts for more than a decade, and have been on an FDA “watch list” for nearly three years. The ban urged by Public Citizen is one that should have been instituted years ago, but, instead, the device manufacturers have continued to aggressively market these devices to unsuspecting patients while the overworked and underfunded FDA reviews mounting data showing that the devices subject patients to serious risk of injuries or death while providing little or no benefits. The consumer organization also seeks a recall of products, and that any similar devices in the future undergo far more rigorous testing prior to being approved for marketing, including the suggestion that the products be re-categorized from Class II to Class III devices under the FDA regulations. The current problems with the emergence of defects in these mesh devices once they are implanted into patients stems, in part, from the improper categorization of the devices in class II coupled with an abbreviated 510k approval process, which permitted them to be approved for sale and implantation with only the most rudimentary tests and did not require thorough testing to confirm that the materials utilized were truly biocompatible. Examples of other class II devices include powered wheelchairs, infusion pumps, and surgical drapes. Unfortunately, little was known about how these devices would perform once they were implanted in women, as very little was done in the way of clinical studies and trials in humans prior to approval for marketing. It is inexcusable that hundreds of thousands of women have become guinea pigs for these inadequately-tested devices.
This petition extends to a number of transvaginal surgical mesh products that are sold in the United States by Ethicon (a division of Johnson & Johnson), American Medical System, Boston Scientific Corp., C.R. Bard, and Proxy Biomedical. The products for which Public Citizen requests a marketing ban and/or recall, includes:
- Gynecare Prolift Total, Anterior and Posterior Pelvic Floor Repair Systems (manufactured by Ethicon, Inc. of Somerville, New Jersey)
- Gynecare Prolift +M Total, Anterior, and Posterior Pelvic Floor Repair Systems (Ethicon, Inc.)
- Gynemesh Prolene Soft Nonabsorbable Synthetic (Ethicon, Inc.)
- AMS Elevate Anterior and Apical Prolapse Repair System (American Medical Systems, Inc., headquartered in Minnetonka, Minnesota)
- Pinnacle Pelvic Floor Repair Kits (Boston Scientific Corp., based in Marlborough, Massachusetts)
- Avaulta Support System (C.R. Bard, Inc. of Covington, Georgia)
- Polyform Synthetic Mesh (Proxy Biomedical, Ltd., baed in Galway, Ireland)
The facts regarding transvaginal mesh, as laid out in Public Citizen’s petition and talking points, are quite simple:
- “Use of surgical mesh for transvaginal POP repair provide no clinically significant benefit compared to repair without mesh using only native tissues”
- “Safety assessment: the use of surgical mesh for transvaginal POP repair commonly causes serious complications”
- “Given the absence of evidence for clinically significant benefit and the overwhelming evidence of very serious, common risks, use of synthetic surgical mesh products for transvaginal repair of POP is not ethically justifiable”
- “Despite a complete lack of clinical data demonstrating that these mesh devices were reasonably safe and effective for transvaginal repair of POP, these devices have been heavily promoted by industry and their highly paid physician consultants. As a result, tens of thousands of women have been seriously harmed, many permanently”
- “Commercial interests related to surgical mesh kits for POP repair have taken precedence over patient safety and welfare”
So, what next? One can only hope that the FDA will soon stop sifting through study after study and the stacks of adverse event reports, and move quickly to grant Public Citizen’s petition and pull these products from the market, or, although somewhat of a fantasy, that the device manufacturers would withdraw the products on their own. The reality, however, is that the FDA is far more prone to warn, and warn, and warn again about safety issues, and leave it to patients and physicians to sift through all of the conflicting information from consumer, patient and legal advocates versus those who seek to defend these products and hope that patients make the correct decision. I hope so too, as that is not an easy task, and is a decision that is fraught with problems if it is made poorly.
August 2011 – FDA: Continuing Concerns Relating to Transvaginal Mesh
August 2011 – Informed Decisions and the Use of Surgical Mesh
August 2010 – Mentor ObTape Vaginal Ling Overview
October 2009 – ProteGen Sling: Overview
February 2009 – Curing Incontinence May Cause Greater Harm
December 2008 – The FDA’s Approval of ProteGen Baffles the Mind
November 2008 – The FDA Transvaginal Surgical Mesh Placement Complications Notification: Manufacturer Identification and MAUDE Report Breakdown by Device
November 2008 – Mentor ObTape Litigation Expands
November 2008 – Tension Free Vaginal Tape (TVT or Vaginal Sling): What is it and how is it placed?
October 2008 – Under the RADAR and Over to Market: FDA 510(k) Submissions for Today’s Vaginal Slings are based on an FDA Equivalent Device That Was Actually Defective
August 2008 – Something Doesn’t Mesh