> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Former BD Exec Petitions FDA on Mesh Products
- URL: https://www.fdaweb.com/former-bd-exec-petitions-fda-on-mesh-products/
- Published: 2023-11-14T12:00:00.000Z
- Updated: 2026-09-14T14:16:09.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5155785

Former Becton Dickinson (BD) medical director **Hooman Noorchashm** has [petitioned](https://downloads.regulations.gov/FDA-2023-P-4962-0001/attachment%5F2.pdf?ref=fdaweb.com) FDA to warn patients about the “unknown and inadequately studied effect” of FDA-regulated mesh products being implanted off-label in cosmetic mastopexy operations on the sensitivity of standard surveillance mammography and ultrasound for detection of breast cancer.

Cardiac surgeon Noorchashm is best known to FDA for his [opposition](https://www.fdaweb.com/login.php?sa=v&aid=D5142572&searchWords=Noorchashm&cate=S&stid=%241%24jy4.wy..%24A0HHPIirR1a0pf6sqbyyf) to power morcellation. He previously alleged his BD employment was terminated in 8/2022 after he continually objected to the company’s alleged practice of not reporting device defects to the agency.

Noorchashm says that during the past decade, an increasing number of plastic surgeons have been using FDA-regulated mesh products off-label in cosmetic mastopexy operations called “internal bra” operations in otherwise healthy women.

“By inducing dense sc arring in the anatomic region in which they are implanted, these mesh products can modify the anatomic configuration of women's breast mounds in ways desirable to the patient,” he contends. “However, given the off-label use of these devices outside of properly designed clinical trials to establish safety, it is not known whether these devices are safe in patients undergoing mesh mastopexy — and, specifically, from an oncological and oncological surveillance perspective.”

Noorchashm says that tissue scarring induced by mesh implantation would have an unacceptably high likelihood of adversely affecting the sensitivity of surveillance mammography and ultrasound for detecting breast cancer. “Without ruling out this adverse possibility, no reasonable surgeon, manufacturer, or regulator should accept the widespread off-label implantation of FDA-regulated mesh products in cosmetic internal bra· mastopexy operations, especially, without any warning to patients.

Additionally, Noorchashm’s petition specifically names his former employer BD and its paid consultants for allegedly being engaged in both promoting and implanting the company’s GalaFLEX mesh product for cosmetic mastopexy operations, which is an off-label use. He says the device was originally designed, intended*,* and patented as a device for mastopexy operations, “though the subsequently submitted 510(k) application to FDA for this GalaFLEX device made no mention of this original design intent or the manufacturer's intended use in mastopexy operations.”