Breast Implant Manufacturer Sientra Files for Chapter 11 Bankruptcy
Sientra, Inc. began pursuing Chapter 11 bankruptcy protection on Feb. 12, 2024. It’s the second breast implant manufacturer to voluntarily file for Chapter 11, less than one year after Ideal Implant Incorporated stopped operating on May 30, 2023.
Many women are expressing concerns and feelings of vulnerability related to the recent announcement regarding Sientra’s voluntary filing for bankruptcy protection, explained Laura Willging, RN, BCPA, and BISA board member.
“Women who felt their warranties provided a sense of device replacement security may now be worried about future uncertainties related to the originally agreed upon support and protections,” she said, “and the potential for serious, unexpected financial burden.”
Details of Sientra’s Bankruptcy Filing
Sientra claims the filing was prompted by shifts in consumer spending habits, macroeconomic factors, and a decline in its breast augmentations, according to Surgical Times. The U.S. breast implant manufacturer’s voluntary bankruptcy filing (case #24-10245) in the jurisdiction of Delaware is to be overseen by Judge John T. Dorsey. It intends to sell its business under Section 363 of the Bankruptcy Code.
The company will reportedly continue to operate during the bankruptcy and sale process, receiving financial support from existing lenders. It has secured $22.5 million in new debtor-in-possession (DIP) financing, including a "roll up" of $67.5 million of its prepetition debt obligations.
“The Company seeks to execute an expedited sale process,” according to a press release in Yahoo Finance.
Legal counsel, investment bankers, and financial advisors will assist.
Will Sientra Honor Patient Breast Implant Warranties?
Sientra has stated it will honor warranties to its breast implant patients and continue “to support its customers during the Chapter 11 process.” The company filed a bankruptcy petition, specifically seeking court approval to honor warranty programs and return/refund policies, aiming to allocate $600,000 for this program.
“This type of announcement, with the unintended element of surprise, tends to reverberate through the community of all breast implant recipients,” Willging said.” It draws attention to another potential vulnerability regarding implantable device commitments — and currently seems to be an outlier of consideration during many informed consent processes.”
For Sientra, breast products represent over 95% of sales. Sientra’s breast products include:
Round silicone breast implants
Shaped silicone breast implants
ACX® breast tissue expanders
According to Sientra’s website, the company’s product portfolio also includes gluteal implants, calf implants, pectoral implants, facial implants, non-breast tissue expanders, and Medgel sheeting.
The "Platinum20" warranty program, which covers implants used on or after May 1, 2018, offered patients 10- or 20-year warranties. The company said it has previously provided replacement implants and cash for unreimbursed medical expenses, reporting around $250,000 in warranty payments each quarter.
The U.S. Food and Drug Administration approved Sientra’s breast implants through the pre-market approval (PMA) process, while the 510(k) process resulted in the clearance of its other products.
“Sientra’s response of hoping to honor patient warranties demonstrates a level of compassionate forethought, as many prepare for implant support uncertainties,” Willging said.