If money was her only goal, Wendy Knecht could have walked away when she settled her lawsuit against a Pasadena plastic surgeon for $1 million.

Instead, the Studio City woman is taking her case to the state, encouraging authorities to prosecute Dr. Max Lehfeldt for altering her medical records after she sued the physician for using an experimental device in her breast reconstruction.

Knecht claimed in her 2016 suit that she was left disfigured and forced to undergo three additional surgeries to remove the device, called a SERI Scaffold, and repair damage caused by its failure.

She said she still suffers from pain today.

Not only did Lehfeldt fail to inform her that the device was not approved for use in such surgeries, but Knecht says the physician altered her medical records to fabricate discussions that never happened.

Lehfeldt’s responses to an earlier investigation by the California Medical Board conflicted with his own notes and testimony during a deposition. In the court filing, Lehfeldt admitted to altering records without notifying the state, providing Knecht with a deficient consent form, and failing to update his website to reflect the U.S. Food and Drug Administration’s unfavorable stance on using SERI in breast surgeries.

Knecht alleges Lehfeldt never offered her any options other than SERI, a product made by a company that paid him nearly half a million dollars for consulting and research over a four-year period.

Knecht has asked the California Medical Board to investigate Lehfeldt, the owner of Teleos Plastic Surgery and a physician at Huntington Hospital in Pasadena, for potentially violating state laws.

“There hasn’t been any accountability,” Knecht said a recent interview. “It’s so outrageous that anyone could get away with this.”

Hospital conducts ‘peer review’

Lehfeldt did not return requests for comment. According to his website, Lehfeldt teaches surgical residents at Huntington Hospital and is affiliated with Southern California Methodist Hospital in Arcadia.

He once appeared on the television show “1,000 Ways to Die” in a segment where a woman’s breast implants explode and kill her on an airplane. He appears as a talking head in the episode, discussing briefly the obsession some young women have with large breast implants.

Dorey Huston, a spokeswoman for Huntington Hospital, would not say if the hospital is investigating Knecht’s claims.

“Like all physicians with privileges at Huntington Hospital, Dr. Lehfeldt is subject to ongoing peer review,” Huston said in a statement.

Last week, Huntington Hospital President Lori Morgan announced plans to form a committee to review the hospital’s policies and procedures related to the safety and dignity of patients. The decision came in the wake of a Los Angeles Times investigation that identified more than 20 women who claimed Dr. Patrick Sutton, a obstetrician, mistreated them during their care. Sutton previously was investigated by the medical board for making sexual comments to a patient.

At that time, a spokeswoman for the hospital said the staff “actively conducts ongoing peer review.” Sutton no longer practices at Huntington Hospital, according to Morgan’s announcement.

Knecht wanted to prevent cancer

Knecht underwent breast reconstruction in 2015 following a double mastectomy. She opted for the surgeries after testing revealed she has the BRCA gene, a mutation believed to increase the risk of breast and ovarian cancer. Her mother died of cancer.

Lehfeldt was highly recommended for the reconstruction and worked at the same hospital as her husband.

The same year as her surgery, the FDA warned Allergan, which manufactures the SERI Scaffold, that the device “has not been cleared or approved for use in breast reconstruction using a tissue expander or implant” and ordered the company to cease promoting it for that use.

New complaint based on altered note

In a complaint to the Medical Board in March, Knecht’s attorney, Robert Vaage, wrote: “Dr. Lehfeldt misrepresented the safety and efficacy of these devices to Mrs. Knecht and her husband (a board certified gastroenterologist), concealed the existence of alternate safer devices/therapies, and altered her medical records to cover up what he did.”

Specifically, Knecht complained to the medical board that Lehfeldt changed his notes from an early meeting to indicate that he discussed the differences between SERI and a more common alternative called AlloDerm.

He admitted to making the changes during a deposition in 2017.

Knecht said that discussion never happened and she was given a consent form that didn’t include any specific information about the risks of SERI. Lehfeldt would later agree that the form was deficient and changed it as a result of the lawsuit, according to court records.

The altered notes were sent to the Medical Board as evidence during an earlier probe and were not properly labeled as a late entry. Doctors are supposed to sign and date changes made to their notes after the fact.

The complaint also alleges that Lehfeldt may have withheld 30 pages of medical records from the state board and accuses him of lying in a response to the board in 2016.

The board closed the first investigation two months after Lehfeldt submitted his records and response.

Second investigation underway

Based on the new complaint, the Medical Board began a second investigation earlier this year that remains ongoing, according to letters provided by Knecht. This time, the evidence includes Lehfeldt’s sworn testimony. The deposition was subpoenaed as part of the probe.

In California, it is a misdemeanor to modify medical records “with fraudulent intent.” The Medical Board’s investigators work with a deputy attorney general to determine if there is sufficient evidence to pursue criminal charges against doctors.

The California Medical Board would not confirm or comment on the investigation.

In one exchange during the deposition, Knecht’s attorney asks Lehfeldt to explain when he made the alterations.

“After you were aware that we were alleging, among other things, that you hadn’t told Ms. Knecht everything you should have told her about SERI, right?” Vaage said.

“Yes,” Lehfeldt replied.

“And is there any reason why you didn’t note it as a late entry when you did it?” the attorney asked.

“Honestly, it was an oversight,” Lehfeldt said.

Deep ties to device’s manufacturer

After her surgery, Knecht learned that Lehfeldt was one of Allergan’s top consultants. He received more than $461,000 from the company from 2013 to 2017, according to financial disclosures filed with the federal Centers for Medicare and Medicaid Services. Both SERI and Natrelle, the expanders used in Knecht’s surgery, were made by Allergan, which settled separately with Knecht for an undisclosed amount.

Allergan sold the SERI product line to Sofregen Medical in 2016, according to a press release.

On his website, Lehfeldt states that he works with Allergan product development, physician education and research. A disclosure added after Knecht’s lawsuit states he owns stock in the company.

When Lehfeldt started working with Knecht, he was also an investigator studying the use of SERI in breast reconstruction, another detail Knecht claims she was never told about.

Lehfeldt denied this in his deposition and in a response to the Medical Board. Lehfeldt stated that he provided Knecht and her husband with verbal disclosures, though he did not always note that in his records.

Unlike the trial’s participants, Knecht wasn’t paid to participate and was not given informed consent, according to her lawsuit. In the complaints, her attorney described it as human experimentation.

‘Never told us he was doing experiments’

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

In the deposition, Lehfeldt also stated it was an “oversight” that his website omits that SERI is not approved for use in breast reconstruction by the FDA. That information continued to be an oversight 2017, according to Lehfeldt’s testimony, and still does not appear to be on his website today.

The surgeon stated in his responses that he relayed that information verbally as well.

Devices that aren’t approved for a specific use are considered “off-label,” but can still be used in most cases. The fact that Lehfeldt had close financial ties to Allergan and was conducting a clinical trial at the same time would have opened him to liability. The FDA requires a physician to follow specific regulations when a non-approved device is used in research, according to an article published by the American Bar Association.

In a response to a negative review on his Yelp page, Lehfeldt called Knecht’s lawsuit “unfounded, unjust and unfair.” He blamed the difficulties of the legal system for his decision to settle.

“I chose to settle not out of guilt but out of a desire to end the process and avoid more of a fight — it just isn’t worth it in the end, even if you win the case,” he wrote.

Knecht said she would not have opted to use SERI if she had known it wasn’t approved. In hindsight, she said she felt Lehfeldt wanted to prove he could use SERI in more complex surgeries.

Like a sponge exploded

The SERI Scaffold is derived from silk and is supposed to be absorbed by the body. In Knecht’s case, it wasn’t and the remnants were left behind. A later surgeon would describe it as if “a sponge had exploded” inside her chest, she said.

For more than a year, she felt a constant tightness and pain in her chest. She was initially told it would go away in the second phase of the surgery, when the temporary expanders are replaced with implants. But then it didn’t stop.

During that exchange surgery, Lehfeldt’s notes indicated he removed part of the SERI Scaffolding that hadn’t been absorbed and noted a buildup of fluid. Knecht alleges she was never told about these complications and it delayed her attempts to get the problem fixed.

“It turned out that was the first sign the stuff was falling apart and not working,” Knecht said.

She would undergo three additional surgeries to try to fix the problem. In their notes, the two other surgeons described having to remove SERI from her chest wall because it had not adhered properly.

The lawsuit was filed in late 2016. An expert opined that Knecht likely suffered nerve damage because of the surgeries. Lehfeldt settled shortly after his deposition for his insurance policy’s limit of $1 million.

“Dr. Lehfeldt put his own financial gain over Mrs. Knecht’s health and safety and he intentionally betrayed his patient’s trust,” said Vaage, her attorney.

The settlement did not include a confidentiality clause.

Knecht said she chose to speak out after learning from his deposition that Lehfeldt performed at least 75 of the same surgeries during and after the clinical trial. Only 23 were officially part of the trial, he said in his testimony.

“The bigger issue is that there are other people out there that this happened to and he is continuing to practice and his practice is flourishing,” Knecht said.