Unapproved Breast Implants: A Surgeon Changed the Chart to Match the Story

Unapproved breast implants from China became an approved brand in the story a surgeon formerly of Burley, Idaho, told his patients, according to the Justice Department’s announcement of the criminal case. He supplied approved-product labels and photographs and changed a patient’s medical record so the implant size matched the product he claimed to have used. He made the paperwork fit the explanation. The patient had pictures of approved implants that were not in her body.

This was a criminal prosecution for receipt and delivery of misbranded devices, and the Justice Department announcement identifies no Medicare, Medicaid or other government payment claim.

Unapproved Implants Presented as an Approved Brand

According to court records described in the Justice Department’s November 14, 2019 announcement, the surgeon knowingly implanted nine pairs of breast implants that the Food and Drug Administration had not approved. The implants came from China, and he used them between March 2014 and April 2015.

The announcement describes a practice that gave patients brochures, handouts, pre-operative worksheets and sample sizers that led them to believe they would receive approved implants. The surgeon chose the implant and supplied the story patients relied on.

Labels, Box Photographs and a Changed Medical Record

The Justice Department’s announcement describes a surgery on February 27, 2015 in which the surgeon placed a pair of misbranded implants from China in a patient. Before and after surgery, he gave her labeling for approved implants and told her she had received a particular approved brand.

He also emailed pictures of boxes and serial numbers for approved implants, falsely claiming that they identified the devices he had placed in her body. A box photograph and a serial number gave the story the appearance of a product that could be traced. But the product they identified was different from the one implanted.

The surgeon also changed the patient’s medical record to show a different implant size. The new entry matched the sizing of the approved implants he said he had used. The false account now had supporting labels, photographs, product identifiers and a chart entry.

An implant size in a medical record looks like a clinical detail. Here, the Justice Department described it as a detail deliberately changed to support the substituted product identity.

The Food and Drug Administration’s Office of Criminal Investigations investigated the case with assistance from the Department of Health and Human Services Office of Inspector General.

Where the Implant and the Paperwork Meet

Implant purchasing often separates the person choosing the device from the institution buying it. A surgeon may strongly influence the brand and type, while a hospital or surgery center buys the product and receives payment for the procedure.

The Senate Finance Committee’s account of the implant supply chain describes manufacturers and their representatives handling orders, delivery, stocking, sterilization, selection, instruments and assistance in the operating room. The commercial relationship can follow the device all the way into surgery.

That wider industry setting explains why different insiders can hold different parts of a product’s history. Purchasing staff may know what was ordered. Someone handling inventory may know which product was available for use. Clinical staff may know what went into the procedure, while the chart records what the provider says was used. Our work connects those views to the same device and procedure.

The Idaho case puts the patient-facing materials alongside that chain. Brochures, sample sizers, labels and follow-up emails each carried the approval representation. We examine where the account of the product changed and who supplied the information behind that change. In a practice where the surgeon directs both product selection and the explanation to the patient, those communications can be as revealing as the purchasing record.

How Does Reimbursement Work for Medical Devices?

For Medicare-covered outpatient procedures, the Centers for Medicare & Medicaid Services’ outpatient payment guide describes implantable devices as generally included in the payment for the service. For an insider who knows which implant was used, the corresponding payment may sit in a bill for the procedure.

When the Approval Story Reaches a Government Claim

In a potential civil case involving government billing elsewhere, the practical question for our whistleblower experts is what the government was asked to pay for and how the description connects to what was actually supplied. The implant records and the bill have to tell that story together.

The Evidence an Insider Can Recognize

The strongest part of the Idaho account is the connection between the false product story and the decision to change the chart. Someone familiar with the original implant or the original entry could recognize why the revised size mattered. Someone seeing only the approved-product photograph would see a different story.

That is the kind of knowledge we work with. A purchasing employee, clinical employee or practice manager may understand the relationship between an order, a product label and a patient record in a way the documents alone cannot explain. We bring that knowledge into the investigation and connect it to the representations and payment decisions that matter to a potential civil case.

For insiders with evidence of false government billing, the recovery is also the basis of a potential reward. A whistleblower case under the False Claims Act can pay 15% to 30% of what the government recovers.

You Know Which Product Was Used

If you know why an implant label, a patient chart and the product used in surgery tell different stories, speak with our whistleblower experts. We build the case with you, connect the product decisions to government billing and bring in medical device fraud whistleblower lawyers who understand both. We stay beside you as partners throughout the case.