Boston Scientific Obtryx Litigation Update

Case No: RG21092570, THE PEOPLE OF THE STATE OF CALIFORNIA v. BOSTON SCIENTIFIC CORPORATION,

Obtryx mesh made from outdated Marlex linked to severe complications; safer alternatives exist, but remain unavailable in the US

LOS ANGELES, CA, UNITED STATES, August 21, 2025 /EINPresswire.com/ -- Dr. Greg Vigna, national midurethral sling attorney, says, “There will always be an Obtryx litigation. The Boston Scientific Obtryx is made from Marlex, a technologically obsolete form of polypropylene developed in the 1950's. There are safer alternative materials available outside of the United States for the treatment of stress urinary incontinence that reduce or eliminate the risk of chronic inflammation when compared with Marlex.”

Boston Scientific admits that the Obtryx sling in their Consent Agreement with California,

"(b) can result in a "serious injury" as defined by 21 CFR § 803.3; or (c) include the following complications, which may be ongoing: i. Pain (pelvic, vaginal, groin/thigh, dyspareunia) (acute or chronic);

ii. Foreign body reaction (acute or chronic);

iii. Erosion into organs; exposure/extrusion into vagina;

iv. Dyspareunia;

V. Scarring/scar contracture;

vi.Mesh contracture;

vii. Tissue contracture;

viii. Fistula formation (acute or chronic);

ix. Inflammation (acute or chronic);

X. Vaginal shortening or stenosis, which may result in dyspareunia and/or
sexual dysfunction;

xi. Pain with intercourse that may not resolve;

xii. Exposed mesh may cause pain or discomfort to the patient's partner during
intercourse;

хії. Infection;

xiv. Sexual dysfunction; including the inability to have intercourse;

XV. De novo detrusor instability;

xvi. Voiding dysfunction (incontinence, temporary or permanent lower urinary tract obstruction, difficulty urinating, pain with urination, overactive
bladder);

xvii. Bruising, bleeding (vaginal, hematoma formation);

xviii. Abscess;

xix. Dehiscence of vaginal incision;

xx. Perforation or laceration of vessels, nerves, bladder, urethra, or bowel may
occur during placement; and

xxi. Failure to resolve a patient's stress urinary incontinence.

(And)
(c) Complete removal of mesh may not be possible and additional surgeries may not always fully correct the complications."

Dr. Vigna adds, “Marlex mesh is a technologically outdated form of polypropylene mesh from the 1950's. Alternatives, such as PVDF and P4HB, offer reduced chronic inflammation compared to Marlex and are already being used outside of the United States to treat stress urinary incontinence. Boston Scientific has the opportunity to introduce these advanced materials to the United States market and profit from it."

What did Dr. Jordi Sabadell’s article “Polypropylene and polyvinylidene fluoride transobturator slings for the treatment of female stress urinary incontinence: 1-year outcomes from a multicentre randomized trail.” Neurourology and Urodynamics. 2021: 40: 475-482?

“Polypropylene and PVDF slings showed similar high cure or improvement rate (91.0% vs. 95.6%)… A higher incidence of long-term pain events were observed in the polypropylene group.”

Read Dr. Sabadell’s article: https://onlinelibrary.wiley.com/doi/pdfdirect/10.1002/nau.24586

Dr. Vigna concludes, “Implanting physicians and their patients are likely to choose materials that reduce chronic inflammation without compromising efficacy. Our criteria includes complications requiring mesh revision beyond 18 months, as well as cases where women experience acute pain and are not offered timely, complete mesh removal."

Dr. Vigna is a California and Washington DC lawyer who focuses on catastrophic pain syndromes caused by the Coloplast Altis sling, including pudendal neuralgia and obturator neuralgia. He represents women with the Ben Martin Law Group, a national pharmaceutical injury law firm in Dallas, Texas. The attorneys are product liability and medical malpractice attorneys, and they represent neurological injuries across the country and the physicians who implant them.

Click here for a free book on Vaginal Mesh Pain.

THE PEOPLE OF THE STATE OF CALIFORNIA, Plaintiff v. BOSTON SCIENTIFIC CORPORATION, Defendant
Case Number: RG21092570

California Offices:
8939 S. Sepulveda Blvd., Suite 102, Los Angeles, CA 90045
2570 N. First Street, 2nd Floor, San Jose, CA, 95131
931 10th Street, #962, Modesto, CA 95354
2281 Lava Ridge Court, Suite 200, Roseville, CA 95661
600 West Broadway, Suite 700, San Diego, CA 92101

Connecticut Office:
515 Centerpoint Drive, Suite #2212, Middletown, CT 06457

Washington DC Office:
700 12th Street, N.W., Suite 700, Washington, District of Columbia 20005

Greg Vigna, MD, JD
Vigna Law Group
+1 8178099023
email us here
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