Report: Despite settlement, patient seeks prosecution for off-label Seri scaffold breast surgery

A patient in Southern California who underwent breast reconstruction surgery using an off-label Seri surgical scaffold is pushing for the state to prosecute the operating plastic surgeon, despite having received $1 million in a settlement, over claims that he altered her medical records, according to a Pasadena Star News report.

The patient, Wendy Knecht, underwent breast reconstruction in 2015 following a cancer-preventive double mastectomy procedure. She was treated by Dr. Max Lehfeldt, who used a Seri surgical scaffold, produced by Allergan (NYSE:AGN) at the time, despite the scaffold having no FDA indications for such a surgery.

Knecht goes on to claim that not only did Lehfeldt use the device off label, they also altered medical documents to conceal the fact that he had not presented safer alternatives to her during an early meeting, according to the report.

Dr. Lehfeldt admitted to making the changes to the documents during deposition last year, the Pasadena Star News reports.

The Seri scaffold was originally developed by Serica Technologies, and won approval for repairing and remodeling damaged connective tissue in 2009. Serica was acquired by Allergan in 2010, which eventually sold the device and its associated IP to Sofregen Medical in 2016.

The FDA warned Allergan in the summer of 2015 about marketing the scaffold for breast surgery indications without appropriate approval, claiming that a review of the Seri website showed it being recommended for use with breast surgery applications.

The device only had indications for “use as a transitory scaffold for soft tissue support and repair to reinforce deficiencies where weakness or voids exist that require the addition of material to obtain the desired surgical outcome,” according to an FDA posting.

Lehfeldt reportedly had ties to Allergan as a consultant, having received more than $461,000 from the company between 2013 and 2017, according to the report. During the period Lehfeldt worked with Knecht, he was also an investigator in a study exploring the use of the Seri scaffold in breast reconstruction.

“He never told us it was off-label, he never told us he was doing experiments with it at the same time. He just used it on me,” Knecht told the paper in an interview.

Knecht eventually settled with Lehfeldt for $1 million, and settled with Allergan for an undisclosed amount, according to the Pasadena Star News, but the settlement with Dr. Lehfeldt did not include a confidentiality clause.

The California Medical Board has launched a second investigation into Lehfeldt in response to the request from Knecht, after an initial investigation closed shortly after Lehfeldt submitted his records and response to the board, according to the report.

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from MassDevice http://bit.ly/2Ct1k9e