Patients with Sientra breast implants are a step closer to having their warranties upheld and honored, despite the company having voluntarily filed for federal bankruptcy protection earlier this week.
They can also expect continued safety oversight from the FDA, an agency spokesperson confirmed.
In its First Day Hearing at federal bankruptcy court on Wednesday, Judge John Dorsey granted the relief requested by Sientra, on an interim basis.
For patients with Sientra breast implants, that means their warranties will remain intact, barring the filing of an objection which the federal court agrees should invalidate or prevent those warranties from being upheld.
Sientra’s motion authorizes, but does not mandate, the continuation of existing patient warranties, as well as implant return/refund policies, among other customer programs.
Bankruptcy Basics
For some, the breast implant manufacturer’s court filing marked the second downfall of an implant manufacturer in two years, the first being Ideal Implant, Inc., which liquidated in May last year.
News of Sientra’s filing was announced February 13, on “Breast Implant Illness Awareness Day.”
As women affected by the illness and advocates shared their stories in honor of the day, some added that the announcement was welcome—and very timely—news.
The U.S. Federal Government, however, says a case filed under chapter 11 — like Sientra’s — “is frequently referred to as a ‘reorganization’ bankruptcy.”
Some of the more well-known companies to have emerged from such filings include American Airlines, General Motors, Marvel, and Six Flags.
At Wednesday’s First Day Hearing, Sientra attorney Nicole Greenblatt said the company had received additional acquisition interest since its filing of a voluntary Chapter 11 petition on Monday.
Against a background of voided patient warranties stemming from Ideal Implant’s liquidation last year, Sientra’s approach to a voluntary Chapter 11 process caught patient advocates off-guard, some of whom presumed the voluntary filing automatically meant patient’s warranties were no longer valid.
But the two breast implant firms are very differently poised, with Sientra working to attain a far more favorable outcome for both patients and surgeons.
Unlike Ideal Implant, Inc., since acquired by Bimini Health Tech with plans to rebrand its namesake device as the “Serene Breast Implant,” Sientra breast implants are likely to be uninterruptedly available for patients and surgeons.
FDA Oversight, Safety Requirements, Remain
An FDA spokesperson further confirmed that existing oversight regulations and requirements, and any ongoing post-market approval studies, would need to be continued.
“The FDA’s decisions are intended to be patient-centric with the health and safety of device users as our highest priority,” an FDA spokesperson outlined by email.
“FDA requirements apply to devices regardless of a firm’s decision to stop selling and distributing the device,” with such requirements typically being in place for at least the expected lifespan of the device.
“They include, but are not limited to, the applicable requirements related to investigating complaints, reporting adverse events to the FDA, conducting post approval studies, tracking devices, and maintaining records.”
Hearing Scheduled
On March 12, patients and surgeons should know for certain whether Sientra’s warranties will continue to be honored.
A Sientra spokesperson confirmed on Friday its receipt of interim approval to maintain warranties.
“Sientra has obtained interim court-approval to perform and honor its warranty obligations in the same manner and on the same basis as it did prior to its Chapter 11 filing,” a spokesperson said.
“We have asked the Court to make this approval final, which we expect to be heard by the Court on or around March 12, 2024.”
Safety studies and FDA oversight remain, despite what happens in that hearing.