Johnson & Johnson Company, Mentor Worldwide LLC, has gained U.S. FDA clearance and subsequently introduced a tissue expander with a smooth surface to its line of CPX4 Breast Tissue Expanders in the United States.
Background
About 1 in 8 women in the United States will develop invasive breast cancer over the course of their lifetime. In 2018, this means an estimated 266,120 new cases of invasive breast cancer are expected to be diagnosed.
Tissue expanders are used for breast reconstruction after mastectomy to expand the breast pocket to accommodate a breast implant.
Mentor Worldwide LLC is a leading supplier of breast implants in the global aesthetic market. The company develops, manufactures, and markets innovative, science-based products for surgical and non-surgical medical procedures that allow breast surgery patients to improve their quality of life.
Mentor’s new CPX4 Smooth device has a smooth surface designed to help ease insertion and removal. Compared with the CPX4 Siltex implant it features additional suture tabs to enhance fixation while reducing the risk of rotation for subcutaneous and submuscular breast reconstruction.
The product was shown at the 2018 American Society of Plastic Surgeons (ASPS) annual meeting in Chicago last week.
Physician comments
“I am looking forward to using the CPX4 Smooth expander in prepectoral and submuscular breast reconstruction,” said Mentor consultant Mark Migliori, MD, a board certified plastic surgeon in Edina, Minnesota. “I believe it will offer ease of use during placement and removal with the added protection of the proprietary BufferZone, along with providing a natural breast shape and a soft comfortable expander for the patient.”
Source: Mentor Worldwide LLC
published: October 10, 2018 in: Approval/Clearance, Johnson & Johnson, Launches / Withdrawals, Oncology, Plastic/Reconstructive