An Orange County woman is suing her physician after an operation to resolve urinary incontinence issues by implanting a mesh sling allegedly resulted in intractable pain and other complications.
The medical negligence lawsuit alleging that plaintiff Roseanne Rivera suffered pain and suffering as a result of the procedure performed by Dr. Catalin Marinescu and OBGYN Care in Newport Beach was filed on Feb. 21 in Orange County Superior Court. The complaint alleges that Rivera suffered groin and perineal pain after an operation in November of 2023 using the Obtryx Halo sling manufactured by Boston Scientific Corp.
The lawsuit argues that Rivera was not properly warned about the dangers and risks associated with the medical device, such as inflammation of pelvic tissue, nerve entrapment, chronic pain and painful sexual relations.
“Defendant Marinescu knew or should have known that the Obtryx Halo polypropylene transobturator sling is causally associated with pudendal and obturator neuralgia and that complete removal of the Obtryx Halo, including the vaginal component and the extra-pelvic arms, is the indicated treatment of pudendal and/or obturator neuralgia, as well as chronic pain in the thigh and/or pelvis pain from complications of the mesh,” the lawsuit states.
The doctor offered to perform a partial mesh removal to treat Rivera’s pain symptoms, but the plaintiff opted instead to have another doctor perform the full removal of the device at a hospital in St. Louis, Missouri, according to the complaint.
The lawsuit is one of many such claims filed nationwide that seek damages awards stemming from injuries suffered by patients who received mesh-device implants.
“Vaginal mesh litigation has become one of the most significant mass torts in recent history, involving thousands of lawsuits against multiple transvaginal mesh (TVM) product manufacturers,” a blog post by the Miller & Zois LLC law firm says.
Boston Scientific declined to respond to the allegations in the lawsuit, saying only that the company does not comment on active litigation matters. One of the plaintiff’s attorneys, Greg Vigna, who is also a medical doctor, indicated in an email that although Boston Scientific is not a defendant in the current litigation, there is a two-year statute of limitations to bring product-liability claims in California.
“Our client is seriously injured from the surgical implantation of the Obtryx sling,” Vigna said in a statement. “Our position is that the Obtryx sling is unreasonably dangerous and that there are safer alternative designs and options. When complications occur, early removal is required.”
The lawsuit centers around Dr. Marinescu’s decision to implant the Obtryx and his failure to treat the resulting complications, according to Vigna.
Boston Scientific and 47 states, including California, entered into a settlement in 2021 to resolve allegations that the company had engaged in deceptive marketing involving its surgical mesh products for women. The result was a $188.6 million payment to the states involved, with California receiving $19.3 million from the settlement, according to the state Attorney General’s Office.
The states’ lawsuit accused the company of misrepresenting the safety of the mesh products and not disclosing the full range of serious side-effects. Millions of women have been implanted with the surgical mesh devices, according to the attorney general, and thousands have alleged serious complications.
The devices have been used for decades to treat stress urinary incontinence and pelvic organ prolapse in women – conditions that often result from childbirth and aging.