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Boston Scientific’s Sec. 522 Studies On Pelvic Mesh Show It’s Too Risky, FDA Says

 
• By Shawn M. Schmitt

The US FDA says final data from two Boston Scientific postmarket studies have reinforced the agency’s position that the company’s transvaginal mesh to treat pelvic organ prolapse (POP) has a poor benefit-risk profile. The firm’s mesh has been off the US market since 2019.

Surgical knife and tension-free vaginal tape on pink background - Image

More than two years after the US Food and Drug Administration forced transvaginal mesh products off the market, the agency says results from two final postmarket studies by Boston Scientific Corp. reaffirm that the mesh is indeed too risky to be used on people.

The FDA in January 2012 ordered Boston Scientific and 32 other makers of mesh to treat pelvic organ prolapse (POP) to conduct 88 separate Sec. 522 studies; by January 2013 the number of study orders grew to 95, encompassing a total of 34 firms

More from Gynecology and Urology

FDA Publishes Updated ‘Roadmap’ For Advancing Women’s Health

 
• By Brian Bossetta

The US FDA’s Office of Women’s Health provides a research roadmap to address health concerns specific to women. The FDA recently updated the roadmap, outlining areas in which further research is needed.

News We’re Watching: New FDA Approvals For Breast Implant, Colon Cancer Test, Imaging Agent; TAP Expansion, AI Standards

 
• By Brian Bossetta, Marion Webb, Elizabeth Orr, and Natasha Barrow

This week, Establishment Labs Holdings announced the FDA gave it premarket approval for Motiva breast implant, Cologuard lands FDA approval for Cologuard Plus and GE HealthCare gets FDA nod for a new imaging agent. The FDA announces another expansion for TAP into ophthalmology and radiology. The AAMI and CTA will join forces to develop standards for AI and ML-enabled health care products.  

News We’re Watching: Neuralink’s Blindsight Gets FDA Breakthrough Device Tag; FDA Pump Recalls, Guidances; Discure, DeepLook Bolster Coffers

 
• By Marion Webb, Brian Bossetta, Elizabeth Orr, and Natasha Barrow

This week, Neuralink announced it received US FDA breakthrough device designation for a device to restore sight; medtechs Discure and DeepLook secured new funding; FDA pump recalls from B. Braun Medical and Fresenius Kabi; Axonics prevails in patent infringement lawsuit with Medtronic; Merit Medical buys Cook Medical for $210m.

Prodded By Congress, FDA Launches Tampon Review

 
• By Elizabeth Orr

The US agency said on 10 September that it plans to study whether heavy metals detected in tampons could endanger their users.

More from Device Area

FDA And Boston Scientific Face Legal Action Over Spinal Device Safety

 
• By Elizabeth Orr

A patient, Dena Lawler, is suing Boston Scientific and the US FDA over alleged harm from a spinal stimulator device. Lawler claims inadequate regulatory review allowed dangerous modifications to the device, which then caused her pain and other health issues. She is calling for reconsideration of the device approvals.

California Medtech Firms Resolve Patent Dispute Over Delivery Catheters

 
• By Brian Bossetta

Route 92 says it has reached a settlement with Q’Apel Medical over patent claims concerning its Tenzing delivery catheters.

Harbinger Health Targets High-Mortality Cancers First With AI-Driven MCED Platform

 
• By Shubham Singh

With a projected FDA submission within the next two to three years, Harbinger is prioritizing cancers based on lethality, prevalence, and unmet diagnostic need. Pancreatic and biliary cancers – often diagnosed at late stages and lacking established screening programs – will be among the initial targets.