Boston Scientific Pelvic Mesh Lawsuit Claims Advantage System Caused Permanent Injury, Deformity

Lawsuit alleges manufacturer should have known the inherent risks of pelvic mesh, yet failed to warn the medical community or patients.

An Illinois woman filed a product liability lawsuit claiming that the defective design of a Boston Scientific pelvic mesh caused complications requiring multiple corrective surgeries, and that she will likely continue to suffer life-long injuries.

The complaint (PDF) was brought by Jessica Guzman in the U.S. District Court for the Northern District of Illinois on June 11, naming Boston Scientific Corporation as the sole defendant.

Guzman indicates she was implanted with a Boston Scientific Advantage Mid-Urethral Sling System, which is a synthetic pelvic mesh designed to treat stress urinary incontinence. However, the lawsuit states that the device later failed, causing severe complications.

Transvaginal Mesh Risks

The Advantage, first approved in 2002, is one of numerous pelvic mesh products sold and marketed by Boston Scientific and other medical device manufacturers in recent years for the treatment of pelvic organ prolapse (POP) or, as in Guzman’s case, stress urinary incontinence (SUI). These pelvic mesh devices are designed to reinforce weakened vaginal walls or support the bladder using a synthetic mesh.

In 2019, the U.S. Food and Drug Administration (FDA) concluded an investigation into a similar type of mesh, known as transvaginal mesh, also designed to treat POP and SUI. The agency determined that transvaginal mesh risks to patients exceeded their potential benefits.

As part of its decision to remove transvaginal mesh products from the market, the FDA cited postmarketing surveillance studies from manufacturers, including two conducted by Boston Scientific, which found that there was little difference in the effectiveness of transvaginal mesh and traditional transvaginal native tissue repair procedures.

As a result, women have filed more than 100,000 transvaginal mesh lawsuits against Boston Scientific and other manufacturers over the last several years. The companies, which also include C.R. Bard, Ethicon and others, have paid out billions in financial compensation. Despite massive transvaginal mesh lawsuit settlements, hundreds of individual cases are still proceeding through state and federal courts.

Plaintiffs like Guzman also indicate pelvic mesh implants are defectively designed and have reported complications, which may include the mesh contracting or shrinking, infections, pelvic pain, vaginal scarring and the mesh eroding into the vagina, in addition to other painful complications. 

Each plaintiff alleges the manufacturer knew, or should have known, about the potential complications, yet failed to provide sufficient warnings to healthcare personnel or patients.

Advantage Pelvic Mesh Injury Allegations

In the complaint, Guzman indicates she was implanted with the Boston Scientific Advantage Mid-Urethral Sling System during surgeries conducted in May 2023 and September 2024, for the treatment of stress urinary incontinence. 

However, she states that the device failed, causing her to suffer permanent and substantial physical deformity, permanent injuries, as well as physical and mental pain and suffering.

The lawsuit notes Guzman has undergone additional surgeries to address the complications caused by the Boston Scientific pelvic mesh failure, and will likely require additional procedures in the future.

“Defendant breached its duties to Plaintiff when it failed to exercise reasonable care in the design, manufacture, testing, inspection, processing, advertising, marketing, testing, labeling, assembling, packaging, distribution, detailing, promotion and sale of its Product so as to avoid unreasonable risk of harm to women in whom the Product was implanted, including Plaintiff.”

– Jessica Guzman v. Boston Scientific Corporation

According to the lawsuit, Boston Scientific’s pelvic mesh “kits,” including the Advantage System, are considered Class II medical devices, which indicates they can be approved through the FDA’s 510(k) approval system. 

This means the manufacturer only has to show that the device is “substantially equivalent” to an already existing device to receive approval. Therefore, Boston Scientific was never required to show the Advantage System was safe or effective.

However, Guzman alleges the company was aware, or should have been aware of serious dangers in the design, regardless of whether the FDA approved it for sale through its fast-track approval system. She presents claims of negligence, design defect, manufacturing defect, failure to warn and breach of warranties. She seeks both compensatory and punitive damages.

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