Whoever said beauty is only skin deep hasn’t looked below to see what Sientra Inc. has made available there recently. The medical aesthetics company now boasts the only tissue expander cleared in the U.S. for exposure to magnetic resonance imaging, an important screening tool for breast reconstruction patients. Sientra’s CTO Denise Dajles told BioWorld the newly cleared Allox2 Pro Tissue Expander builds on the original expander also cleared by the FDA. “No other expander in the market has an MRI compatibility indication because they are based on a metal, i.e., metallic ports and big magnets in them,” Dajles explained.

The U.S. FDA has updated its data on the number of fatalities across globe associated with breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), which has now reach 59 fatalities. That number is up from 33 reported in July 2019 but is also a number the agency continues to assert may be a significant undercount.

Collplant Biotechnologies Ltd. has signed a collaboration agreement with 3D bioprinting company Cellink AB for future commercial production of regenerative breast implants. Rehovot, Israel-based Collplant has developed prototypes of 3D bioprinted implants and is evaluating them in preclinical studies. The regenerative implants are designed to degrade over time and be replaced by new, naturally grown breast tissue. The technology aims to overcome the challenges of existing breast procedures that use silicone implants or autologous fat tissue transfer.

The U.K. Medicines and Healthcare products Regulatory Agency (MHRA) has issued an advisory regarding the risk of anaplastic large cell lymphoma (ALCL) in association with breast implants, but stopped short of recommending explant for asymptomatic patients.

The FDA has undertaken several new actions in connection with breast implants, including a new restriction on distribution to implant centers that review a pre-implant checklist with patients receiving implants. However, the agency has also mandated that manufacturers add a black-box warning of potential adverse events, such as the risk of developing anaplastic large cell lymphoma (ALCL).

The U.S. FDA’s effort to compile a guidance for prescription, point-of-care (POC) blood glucose meter (BGM) test systems seems to show that guidances can be as iterative as the devices they govern. The FDA announcement for the Sept. 28, 2020, final guidance said that the differences between the 2020 final and the 2018 draft include “a minor edit” regarding user accessibility and a technical correction for hemoglobin testing concentration, yielding a document that is finally ready for prime time after four tries over six years.

Sientra Inc., of Santa Barbara, Calif., reported gains in both its breast products and Miradry segments during its fourth-quarter earnings call after the close of the market March 11. For his part, CEO Jeff Nugent noted that the company had experienced record total net sales in the fourth quarter of $23.2 million, representing growth of 22% year-on-year. However, the company provided full-year 2020 guidance for 12% to 17% growth, which William Blair’s Margaret Kaczor said was below her organization’s 22% estimate, “though the shortfall is largely a result of negative impacts from COVID-19.”

Establishment Labs SA, from the Virgin Islands and with main manufacturing and marketing operations in Alajuela, Costa Rica, where it was founded, is entering the Japanese market with what it says is a revolutionary breast implant solution, starting this month.