FDA Should Not Approve Boston Scientific 522 Studies for Pelvic Mesh

Greg Vigna, MD JD
February 13, 2019
Dr. Greg Vigna, MD, JD

Mesh News Desk, February 13, 2019 ~ Editorial by Dr. Greg Vigna, MD, JD

Boston Scientific Corporation is marching down a dangerous course for women as it is complying with the FDA 522 orders related to transvaginal mesh (TVM) devices used for the treatment of pelvic organ prolapse (POP).

As per the FDA’s 522 orders, Boston Scientific is proceeding with the Premarket Approval (PMA) procedure that will allow for it to market its Uphold LITE (polypropylene) device for anterior and apical prolapse.

Boston Scientific will be protected from future product liability lawsuits if it complies with the FDA 522 orders unless the studies are fraudulent. Under federal preemption, if a product undergoes premarket approval by the FDA, it is immune from lawsuits. That's because federal law, ie, the FDA, trumps state law.  A state cannot bring an action against a federally-approved device.

Since most mesh has been approved under the 510 (k) clearance process, it did not enjoy that protection from lawsuits.

Dr. Greg Vigna, MD, JD, a practicing physician, and national pharmaceutical injury attorney is assisting Plaintiff Steering Committees in various national litigations including the IVC filter litigation, Hernia Mesh litigation, and Mirena Pseudotumor Tumor Litigation and has reviewed dozens of manufacturer sponsored studies and notes that these studies are ‘fraught with obvious flaws that are grounded by bias aimed at obtaining a specific result that is required to proceed on with FDA approval as opposed to testing a hypothesis by an unbiased study procedure."

Dr. Vigna does agree with the final conclusion of the February 12, 2019 FDA Executive Summary (here)  ‘Surgical Mesh for Transvaginal Repair of Pelvic Organ Prolapse in the Anterior Vaginal Compartment’ in that the FDA affirms its prior decision that the risks versus benefit of transvaginal mesh (TVM) devices do not justify their use at this time because these are permanent devices and the benefit must be clear and superior to non-polypropylene mesh procedures used in the treatment of POP.

Dr. Vigna’s opinion, is the following:

“The FDA doesn’t have the tools, expertise, and manpower to identify the bias in the studies just as it doesn’t have the tools, expertise, and manpower to monitor the complaints reported through its Medical Device Reporting (MDR) mechanism.  Review of the top 10 complaints that led to MDRs reported related to TVM polypropylene devices from January 2008 to October 2018 doesn’t capture their catastrophic consequences.  In the Figure 6, provided in the FDA Executive Summary there isn’t specific enough details that capture the seriousness of these injuries.  For example: ‘pain’ is not quantified as to it severity and effect on function, ‘injury’ is patently vague, and ‘neurological deficit/defect’ isn’t specific as to its origin, and ‘disability’ is helpful to some extent but isn’t clear if this relate to inability to provide for simple activities of daily living or if this relates to vocational loss”.

Figure 6 – MDRs per year from January 2008 to October 2018.

Table 1 depicts the top ten patient problems received from January 2008 to October 2018. Please note that codes of “Other (for use when an appropriate patient code cannot be identified)” (n= 1,794), and "No Code Available" (n= 561) did not provide any insight as to a device problem and were therefore omitted from the table identifying the top patient problems. This list is not all inclusive and more than one patient problem code is often found in a single MDR.

Patient ProblemCount1Pain37172Erosion/Exposure35093Infection17944Injury17015Incontinence8146Scar Tissue7617Bleeding4758Infection, Urinary Tract3719Disability33910Neurological Deficit/Dysfunction272

Table 1 – Top 10 patient problems for MDRs received from January 2008 to October 2018.

Dr. Vigna has concerns that “the Executive Summary’ doesn’t mention anywhere the specific diagnoses of pudendal neuralgia, obturator neuralgia, and complex regional pain syndrome as these diagnoses represents the most catastrophic complications of the TVM polypropylene devices used for POP and SUI.

He states, “if the FDA Executive Study doesn’t mention these diagnoses, how will a study devised by Boston Scientific identify them for the PMA process."  He goes on, “How will women be compensated for their foreseeable injuries caused by the defective device because a device that has gone through the PMA procedure will protect a manufacturer from lawsuit unless the results of the studies were obtained by fraud."

Dr. Vigna is a national pharmaceutical injury attorney, who represents new injuries in cases filed outside the Multidistrict Litigation (MDL) in multiple states, and women within the MDL with diagnoses or symptoms of pudendal neuralgia, obturator neuralgia, and complex regional pain syndrome who are preparing for individual litigation outside the confines of the Matrix Settlements.

Greg Vigna - https://pudendalportal.lifecare123.com

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