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Dec 09, 2023

A Long, Hard Fight Over The First Cosmetic Penis Implant

The 43-year-old patient lay unconscious on the operating table, arms

The 43-year-old patient lay unconscious on the operating table, arms outstretched as if nailed to a cross. An oxygen tube snaked out of his mouth, and wires ran from patches on his chest to an electrocardiogram machine, which tracked his heartbeat with a metronomic pulse. A portly man—220 pounds, a few inches shy of six feet—his nude torso was covered in a blue sheet except for a square opening that framed his groin. A surgical technician stood to the man's right, using a metal clamp to pull tight the loose skin of his scrotum. Across the table, James Elist, a cherubic urologist with a thick Persian accent and a prosperous belly, switched on his electrosurgical scalpel.

Bending over the patient, the 73-year-old physician made a shallow, crescent-shaped cut at the base of his penis with the penlike instrument, which uses a high-frequency electric current to burn through tissue. A thin plume of white smoke and the acrid smell of singed skin rose from the incision. As the surgical tech held the cut open with a retractor, Elist worked a gloved finger inside the scrotal sac and up the shaft of the penis. Then, like a magician performing sleight of hand, he deftly flipped the penile skin inside out to reveal a tubular, milky white organ about the size of a forefinger. "This is the penis without the skin," Elist told me. It looked like some sightless creature found in the ocean depths, where sunlight never penetrates.

Setting the penis down, he picked up a translucent silicone sheath that opened along one side, like a hot dog bun. Elist squeezed the device to demonstrate its flexibility. The Penuma, a portmanteau of "Penis New Man," is the world's first and only FDA-cleared cosmetic penile implant. Since patenting the invention in 2002, Elist has implanted thousands of Penumas at his private practice in Beverly Hills, California, where I was observing this surgery. The prosthetic goes beneath the penile skin, adding up to two inches of girth, and comes in five sizes, ranging from L to XXL. "Nobody," Elist explained, "wants a medium."

Supersizing your penis does not come cheap. The 45-minute surgery costs $17,000, which patients must pay out of pocket, because health insurance companies consider it an elective procedure. Still, the device has become so popular, thanks partly to coverage in magazines such as GQ and Men's Health, that physicians from around the country have made pilgrimages to Beverly Hills to train with Elist—a requirement for becoming a Penuma-authorized surgeon.

Among them was Houston urologist Robert Cornell, who shadowed Elist in the operating room for a day in March 2018. But Cornell never completed the training. Instead he developed his own cosmetic penile implant, one intended to correct what he considered the Penuma's deficiencies. He recruited a group of prominent Texas physicians to help design the device, which he called the Augmenta.

It took eighteen months for Elist to learn about Cornell's project, time that the industrious Houstonian used to build an Augmenta prototype, secure a patent, and raise more than $1 million from investors. Cornell was in the final stages of receiving FDA clearance to begin implanting the Augmenta when Elist sued him and his partners in federal court, alleging that they stole his trade secrets.

After three grinding years of litigation, involving dozens of high-priced attorneys in two states, the lawsuit went to a jury trial in Los Angeles this week. At stake are millions of dollars in potential damages, as well as access to the burgeoning international market for cosmetic penile implants.

The case may also carry implications for patient safety. Though Elist says he has thousands of satisfied customers, the implant has been dogged by reports of horrific side effects. In a separate civil lawsuit, a Penuma patient from Hidalgo County, in the Rio Grande Valley, is suing Elist for allegedly misrepresenting the device's safety record. Cornell contends that preventing the Augmenta from coming to market, as Elist's lawsuit seeks to do, would deprive men of a safer way to enlarge their penises. (Through his attorney, Cornell and his codefendants declined requests to be interviewed for this story. The following account of their actions is based on their statements in depositions and other legal filings.)

To Elist, the case has always been simple. The way he sees it, his life's work was stolen by a band of medical pirates trying to make their fortune off someone else's sweat. "It took twenty years for me to reach this point [with the Penuma]," he told me. "How can someone who never came out with any kind of innovation or new idea, in a matter of months, come up with this idea? There's no way. It's impossible."

Penis enlargement is an ancient obsession. The Kama Sutra, written around the fourth century, advises men to rub their private parts with wasp venom to induce swelling. The Topinama people of sixteenth-century Brazil were rumored to favor snake bites. In the 1930s, anthropologist Margaret Mead observed Polynesian men stretching their penises with weighted objects, a practice that has also been documented in parts of Africa and South America. A strenuous penile exercise regimen known as jelqing is believed to have emerged from the Middle East. In recent decades, some who feel shortchanged by nature have turned to injecting their penises with silicone gel, or with fat taken from another part of the body. These injections can have grotesque side effects, but that hasn't stopped men from seeking them out.

In the mid-nineties, victims of botched procedures began showing up at James Elist's office. Born into a wealthy Sephardic Jewish family in Iran, Elist earned his medical degree from the Tehran University of Medical Sciences before moving to Washington, D.C., in 1976 to complete a residency at George Washington University Hospital. He was planning to return to Tehran to practice medicine when the Iranian Revolution broke out. With the country's Jewish minority under attack from revolutionary leaders, Elist opted to join a urology practice in Los Angeles. Later he was able to bring much of his family to California, though they had to abandon most of their wealth. "I had to start over from scratch," he told me.

In Beverly Hills, Elist established a specialty in treating erectile dysfunction. He published a research paper linking smoking to impotence and was among the first urologists to implant inflatable penile prostheses, which use an air pump concealed in the scrotum. As his practice grew, he started seeing more patients suffering from complications that arose after penile injections. "They had gotten silicone injections, gel injections," he told me. "Their penises had been damaged. Totally deformed." Most of the time, there was little Elist could do. "I’ll never forget the face of this young man—twenty-three, twenty-four years old. He was standing in my office, crying, saying, ‘Dr. Elist, do something for me.’ Unfortunately, I could not do anything, because he had gotten fat injections."

Elist started thinking about a safer alternative. Living in Los Angeles, he couldn't help noticing the growing popularity of silicone breast implants. Why couldn't there be a similar implant for penises? His colleagues were skeptical. "The idea of putting something under the penile skin was not acceptable to most of the urologists at that time," he recalled. "They would say, ‘James, it isn't going to work. When they have sexual activity, it's going to perforate the skin.’ There were a lot of negative feelings about it."

Undeterred, Elist hired a Sacramento manufacturer to build a series of ultrasoft silicone prototypes, which he began testing in cadavers—a standard practice for new medical devices. He experimented with different implant sizes, surgical techniques, and sutures before receiving the first of several patents for technology related to what would become the Penuma in 2002. Like many others, Elist then took advantage of a regulatory loophole in seeking the FDA's blessing.

Known as a 510(k) clearance, it sets aside the requirement of a full safety review for biomedical inventions determined to be "substantially equivalent" to products that were on the market before the passage of new federal regulations on medical devices in 1976. Elist argued that his implant was similar to the silicone implants long used in ear, nose, and throat surgeries. The FDA agreed in 2004, granting Elist permission to begin implanting the device "for use in the cosmetic correction of soft tissue deformities."

Deformity, Elist believes, lies in the eye of the beholder. He began advertising his invention, named the Penuma at his son Jonathan's suggestion, as the "first FDA-cleared penile implant for cosmetic male enhancement." Thousands of men flocked to his clinic for the surgery, and most seemed happy with the results. One of them, a 52-year-old nurse from California whom I’ll call Marco, told me that his flaccid penis used to almost completely retract into his scrotum, like the head of a frightened turtle—a condition known as buried penis. The Penuma prevented this disappearing act, giving Marco more confidence with women and improving his sex life. He said it feels natural enough that his sexual partners can't tell it's there: "I walk naked around the room now, and don't have any issues."

The Penuma has received positive (albeit snarky) coverage in Cosmopolitan, GQ, HuffPost, Men's Health, and Vice. TMZ hailed Elist as the "Thomas Edison of penis surgery." The urologist appeared on a Los Angeles radio show with one of his patients, who happily dropped his pants in front of the hosts. Yet horror stories about the procedure also began to circulate online, in places such as the Reddit forum PenumaProblems. In March the news website Insider published a story based on interviews with several patients who said the operation had permanently damaged their penises.

At least twelve patients have filed complaints about Elist with the Medical Board of California. One, a 54-year-old anesthesiologist from Texas, sought treatment in 2015 to correct scarring from a hernia surgery. On his intake form, the man indicated that he was also dissatisfied with the size of his penis, leading Elist to recommend the Penuma—even though the man's dimensions were, according to Elist's own notes, within the average range.

The man agreed to the surgery, but after returning to Texas he reportedly experienced irritation and swelling, found sex painful, and had trouble urinating and ejaculating. After consulting another urologist, who told him the Penuma was compressing his urethra, he elected to have the device surgically removed, which left his penis scarred and 2.5 inches shorter than its original length. In 2019, the California medical board elected not to discipline Elist for negligence, but it did censure him for failing to "maintain adequate and accurate medical records" about the man's case. To keep his license, Elist agreed to enroll in a course on medical recordkeeping.

Earlier this year, complaints from ten Penuma patients led to a second investigation of Elist by the California medical board. If he's found guilty of the alleged gross negligence, incompetence, and failure to maintain adequate and accurate medical records, his medical license could be suspended or revoked. "Penuma is an innovative procedure, and innovative procedures are routinely reviewed by regulators," said Elist's attorney in a statement to Texas Monthly. "We are working to fully resolve the matter with the Board."

Elist insists that the Penuma is safe so long as the patient complies with his instructions for postsurgical care, including refraining from sexual activity for six to eight weeks. In 2018 Elist coauthored a paper in the Journal of Sexual Medicine that tracked a sample of four hundred men who received the Penuma between 2009 and 2014. The study found that the patients experienced an average 57 percent increase in penis circumference, or girth, with 81 percent reporting "high" or "very high" satisfaction. (The Penuma added around one inch to the length of flaccid penises; the study did not measure the effect on erect ones.) The most frequently reported complications were scar formation (8 percent), seromas (buildups of fluid; 4.8 percent), and infection (3.3 percent). About 3 percent of patients had to have the implant removed because of one or more complications.

"There is no way you can find a procedure that has no complications," Elist told me. Even in commonly performed operations such as vasectomies or circumcisions, he pointed out, things sometimes go wrong. "There are no minor procedures," he quipped. "Only minor surgeons."

In photographs, Robert Cornell has the confident, blandly handsome look of a TV weatherman. The 52-year-old Pennsylvania native earned his MD from Columbia University and completed his residency at Baylor College of Medicine, in Houston, before opening his own practice. Sometime around 2017, he realized he had a problem.

Like Elist, he had developed a specialty in inflatable penile prostheses. In recent years, though, insurance companies increasingly wouldn't pay for those operations. "So with what is, you know, a fundamental part of my clinical practice becoming less and less available to more and more patients, you know, expanding and broadening my service offering to more patients was a priority of my business," Cornell would recall in a 2020 deposition. "I understood that there was a single device available for cosmetic male enhancement, and I pursued more information there."

Cornell had already received several inquiries about the Penuma from patients at his downtown Houston urology office before he traveled to San Antonio, in October 2017, to attend a four-day meeting of the Sexual Medicine Society of North America. There he met Tom Hopper, president of Gesiva Medical, the Minnesota-based company that distributes the Penuma. He told Hopper he was interested in setting up a trip to Beverly Hills to train with Elist, who had only recently begun authorizing other surgeons to implant his invention.

The San Antonio conference also happened to host the first meeting of an advisory board of experienced urologists Elist convened to help develop and market the Penuma. Among the board members was Run Wang, then SMSNA president, whom Hopper had known for years and considered "a recognized key opinion leader in urology." The 62-year-old Chinese American physician was a professor of urology at UTHealth's McGovern Medical School and MD Anderson Cancer Center, in Houston. Wang signed an eight-page consulting-services agreement with International Medical Devices, the company founded by Elist in 2013 to commercialize the implant. The agreement included a confidentiality clause prohibiting Wang from disclosing any proprietary information he learned from his role on the board.

The CEO of International Medical Devices was Elist's 38-year-old son, Jonathan, a Stanford MBA who had left his job as a management consultant at McKinsey & Company to run his father's business. Jonathan served as his father's representative at the advisory board's first meeting, in a conference room at the Marriott Rivercenter hotel. The meeting's highlight was a live demonstration of the Penuma by one of Elist's patients, who allowed the urologists to inspect his silicone-enhanced penis. "They grabbed gloves, put them on, and just tried to get as close as they could," Jonathan recalled. "Some were on their knees. They wanted to not only see it, they wanted to inspect it to know how natural it felt."

After the examination, several of the urologists asked to train with Elist so that they could offer the Penuma at their own practices. Wang was among the first to complete the training. Delighted to have one of the country's most prominent urologists on his advisory board, Elist even paid for Wang's travel to Los Angeles.

In a 2021 deposition, Wang explained that he was aware of patient complaints about the Penuma, but he believed he could help Elist improve the device. "As a professor, as an academic physician, the patient safety is my number one priority," he said, according to the deposition transcript. "My intention was that, as [an] expert in sexual medicine society and in [the] sexual medical field, if I could do something—contribute something to help this procedure . . . that was my professional job."

Cornell flew to Los Angeles for his own Penuma training in March 2018. He observed Elist perform four back-to-back procedures during a single day, in a windowless operating room at the Beverly Hills South Pacific Surgery Center, across Wilshire Boulevard from Elist's office. As he watched, Cornell moved around the room to get different perspectives, peppering Elist with questions and scribbling notes on a small card. At one point he stood on a stool to get a bird's-eye view.

Surgical tech Minerva Acosta, who was assisting Elist that day, would later recall that Cornell "asked many more questions than other visiting doctors I have observed" and "seemed extremely interested in the design and use of [the] Penuma." Cornell, she said, appeared particularly focused on the sutures and polyester mesh used to attach the device to the penis, and inquired about "changes or improvements planned or considered for [the] Penuma." Elist recalled telling Cornell about his plans to incorporate absorbable sutures, mesh tabs, internal air pockets (to increase the device's softness), and an antibiotic coating in future versions of the implant. (In a 2020 deposition, Cornell said there "wasn't much dialogue between me and Dr. Elist" during the surgeries.)

Before leaving for the day, Cornell signed a three-page nondisclosure agreement stipulating that he would only use what he learned "for purposes of discussing and proposing the terms of a possible agreement/collaboration," and that he would not "use directly or indirectly the Confidential Information for [his] own benefit or benefit of any other person." (Through his attorneys, he would later deny being "provided any non-public information related to Penuma before or after signing the Penuma NDA.")

Three days later, back in Houston, Cornell received a list of the instruments and supplies used in Penuma operations, information he had requested from Gesiva representative Duncan Louie. "I will work on a return date in late May for training cases with Dr. Elist," Louie wrote. "Let me know if you need anything additional. Looking forward to it!" Over the next several weeks, Cornell continued to correspond about the May trip, giving Louie the impression that he intended to complete his Penuma training.

Yet Cornell was already working on his own design for a penile implant. In a sworn statement filed as part of the subsequent lawsuit, he wrote that "while observing the Penuma device and implant procedures at Dr. Elist's facility, I noticed several issues that could be problematic. For example, the excessive rigidity and bulkiness of the Penuma device increased the risk of skin erosion, patient and partner discomfort, and the need for device removal." Cornell did not share these concerns with Elist. Instead he "began considering designing a cosmetic penile implant that differed dramatically from the Penuma device."

Cornell showed a copy of the NDA he had signed in Beverly Hills to his attorney, who assured him that, since the document wasn't a noncompete agreement, he could proceed. "I wanted to know that I could legally pursue an implant that I believed would be safer," Cornell later explained. "I didn't want to waste my money or anyone else's time or money, nor did I want to infringe on anyone else's intellectual property."

Under U.S. law, inventors can apply for a patent to cover "any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof." After examining Elist's patents, Cornell seemed satisfied that his implant would represent enough of an improvement upon the Penuma to meet that standard.

To aid in the device's design, Cornell assembled an informal group of advisors, most urologists from Houston. Huck Medical Technologies, a company based in the East Texas town of Jacksonville, was tapped to develop a silicone device that Cornell dubbed the Augmenta. Cornell's longtime friend Richard Finger, an investment advisor who, in his spare time, wrote, directed, and acted in low-budget movies, loaned him $300,000 to pay for start-up costs.

On July 23, 2018, less than four months after visiting Elist in Beverly Hills, Cornell filed his first provisional patent application for "penile implants that facilitate tissue expansion." The Augmenta would feature air pockets embedded in the silicone to make the implant lighter and more flexible. (This wasn't entirely a new idea; the concept was patented in 1992 by French physician Louis Subrini.) In addition to these air pockets, the Augmenta—unlike the Penuma—would incorporate mesh tabs along the length of the penis, as well as absorbable sutures and an antibiotic coating.

Cornell's team pitched the Augmenta, with Huck Medical's initial renderings of the device, to colleagues and potential investors at SMSNA's 2018 meeting, in Miami Beach, Florida. Attendees were shown a slide deck that emphasized how the Augmenta would be softer than the Penuma, offer a "natural-feeling penile shaft," and prevent the "common Penuma complaint of implant buckling and deformity during shaft compression." The presentation pegged Elist's annual revenue on the Penuma implant at about $20 million, based on an estimated manufacturing cost of $250 per implant for about one thousand surgeries per year. (Jonathan Elist would not disclose the Penuma's revenue, but he said it was less than $20 million a year.)

The slides concluded with a series of Augmenta revenue projections, based on a proposed sales price of $4,000 and a onetime $10,000 certification fee for each doctor wishing to perform the operation. If 75 surgeons were certified the first year, the company's net revenue would be around $3.1 million. Using those figures, Augmenta LLC offered shares at $12,000 in exchange for a 0.1 percent ownership stake—giving the company a $12 million valuation.

In eventually raising more than $1 million, Cornell felt the need to disclose the risk of litigation. He sent a memorandum to potential investors noting that Elist "might object to the existence of a competing product, and could file a lawsuit in response."

The first Augmenta prototypes were ready by December 2018. Sometime that month, Cornell and Larry Lipshultz, a Houston urologist and Augmenta investor, implanted the devices in a pair of human cadavers. A few days later, Cornell conducted another pair of cadaver surgeries, this time with Run Wang and Wang's former medical fellow Jonathan Clavell, a 38-year-old urologist who had recently joined Cornell's practice.

Wang had learned about the Augmenta earlier that year and signed an NDA with Augmenta LLC in November 2018. At the time, he was still a member of the Penuma advisory board. He did not tell Elist about his involvement with Cornell, nor did he tell Cornell about his confidentiality agreement with Elist. (In a deposition, Wang said he couldn't recall whether he discussed his Augmenta work with Elist's team.) Wang received one share in Augmenta LLC for his help designing the implant.

Cornell's team was encouraged by the results of the cadaver surgeries. In an email to investors, Finger, who had taken on an advisory role with the company and was one of its largest investors, wrote, "We learned a lot of great things, and Huck is busy making a few minor modifications to further improve the Augmenta." According to Cornell, those modifications included adjustments to the size and shape of the air pockets to achieve better elasticity. The Augmenta ultimately went through twelve iterations before arriving at its final design.

A few weeks after the first cadaver tests, Cornell filed the first nonprovisional patent application, with Huck Medical CEO David Nichols and Hans Mische, a Minneapolis biomedical engineer who had done some early work on the project, listed as coinventors. The application included thirteen pages of diagrams and a lengthy description of the implant. "Currently available cosmetic penile enhancement devices suffer from a number of limitations and deficiencies," the application reads. "Some comprise a rigid, inelastic silicone block that increases the risk of external erosion, patient discomfort, and an unnatural flaccid penis look and feel." The Augmenta, on the other hand, "greatly reduces these untoward complications" by using an antibiotic coating, absorbable sutures, mesh tabs, and internal air pockets.

The U.S. Patent and Trademark Office rejected the application, concluding that the invention was too similar to the Penuma and other existing patents. Cornell, Nichols, and their attorney appealed to a patent examiner in a phone call that April, pointing to how the air pockets made their invention different from Elist's. The examiner emphasized the need for the diagrams in their patent application to feature the elements they were claiming as unique to the Augmenta. An amended application was soon filed, with drawings that more clearly labeled the air pockets, along with other changes, and in September 2019 the PTO granted the Augmenta patent.

After a year and a half of work, all that remained before Cornell could begin implanting the device in patients was FDA clearance. He didn't think that would take long. In an email to his advisory board around this time, he wrote, "I expect a swift 510(k) approval based on historical predicate experience. Sizing kits with further instructions will be available shortly and each of you can soon expect to receive actual implant-grade models for your review." In preparation for the implant's debut, Cornell built a flashy Augmenta website, compiled a list of potential patients, and began hiring employees.

Then he learned he was being sued.

In October 2019, James Elist was taking a break between Penuma operations at the Beverly Hills South Pacific Surgery Center when he received a Google alert on his phone for "penile implant." Clicking the link led Elist to a recently issued patent featuring schematic diagrams that looked sickeningly familiar. Of the listed inventors, he’d never heard of David Nichols and had only briefly met Hans Mische at a conference, but he remembered Robert Cornell well. As Elist read the patent, he was stunned to find many of the design changes he planned for future versions of the Penuma—changes he says he had discussed with Cornell. Elist felt betrayed. "It's like you invite someone back to your home for dinner, and then they steal your valuables," he told me.

He immediately emailed the patent to his son. "My heart sank at that moment," Jonathan recalled. "Then, once I took a look at the patent and saw the claims, I was livid. I knew these were future design concepts that we had discussed with Implantech [the company that manufactured the Penuma], that were part of our catalog of trade secrets. Seeing it right there in the patent, under Cornell's name, was infuriating."

Jonathan, too, had reason to remember Cornell. Shortly after the Houston physician visited Los Angeles, he started identifying himself as a "Penuma Penile Enhancement Specialist" on his website, urosurgeryhouston.com, despite never completing the training. The website also featured a search engine–optimized Penuma Q&A page, with a link for patients to book an appointment. Around the same time, Cornell started paying Google to display ads for his practice next to search results for "Penuma." The website of his colleague Clavell also featured at least one Penuma reference.

In June 2018 Jonathan emailed Cornell to demand the removal of all Penuma references from his website and advertising. Cornell agreed to do so but appears to have slow-walked the process; a year and a half later, when Elist discovered Cornell's Augmenta patent, the website still featured Penuma content. As the Penuma team grew more suspicious of Cornell, it hired Los Angeles attorney Ryan Baker, a specialist in intellectual property law.

In April 2020 Baker filed a 36-page civil complaint against Cornell and Clavell in the U.S. District Court for the Central District of California, based in downtown Los Angeles. The complaint alleged misappropriation of trade secrets, breach of contract, breach of good faith and fair dealing, and unfair competition. (Given the continuing dispute over Cornell's website, Baker also threw in charges of trademark and copyright infringement.) The complaint described Cornell's visit to Beverly Hills as "nothing more than a ruse to steal trade secrets"—secrets that Cornell used to design the Augmenta. "Of course, Dr. Cornell wrongfully claims inventorship," it continued. "But he did not invent; he stole."

To defend themselves, Cornell and Clavell retained Los Angeles attorney Heather Mayer, a specialist in business litigation. Mayer fired back at the lawsuit with a nineteen-page response denying each of Elist's allegations. The response acknowledged that Cornell added Penuma references to his website after returning to Houston, "in anticipation of being approved for using the device." But these references were merely "descriptive," and did not constitute trademark or copyright violations.

As for the most serious allegation, misappropriation of trade secrets, the response laid out what would become the heart of Cornell's defense: the Houston urologist could not have stolen Elist's trade secrets because the information Elist disclosed to him was not secret. All of the supposedly proprietary design features that Elist and Cornell allegedly discussed—absorbable sutures, antibiotic coating, mesh tabs—were widely known and commonly used surgical techniques. The plaintiffs responded that, common though the techniques may be, they had not previously been used in penile-enhancement implants.

University of Houston law professor Aman Gebru, an expert in intellectual property law who is not involved in the case, told me that the dispute hinges on two questions. Did Elist's planned uses of these design features in future versions of the Penuma constitute trade secrets? And did Elist take reasonable precautions to protect those secrets? "To the extent you can prove you’ve [protected the secrets] through NDAs and other similar measures, you can say you have a trade secret," Gebru said—as long as the plaintiffs can show that "nobody has ever combined these features in this industry."

The case was assigned to Judge Consuelo Marshall, who soon had to decide whether to grant a preliminary injunction barring the defendants from seeking FDA clearance for the Augmenta. In a sworn statement, Cornell said his company had already spent about $500,000 on development, and that putting the Augmenta on ice would cost another $7 million to $10 million in lost revenue. The plaintiffs countered that allowing the Augmenta to go to market would cause irreparable harm to Elist by cutting into sales of the Penuma. They argued that the defendants’ actions had already cost them approximately $5 million in lost revenue; if the Augmenta were allowed to proceed to market, they said, their losses could run as high as $100 million.

In January 2021 Marshall issued the injunction, ordering Cornell and his codefendants to stop "commercializing, marketing, advertising, promoting, offering for sale, and/or profiting from the Augmenta implant." Cornell would also have to return or destroy the notes he made at the Beverly Hills surgery center and the list of Elist's surgical instruments and supplies that he had been given. Marshall allowed the defendants to keep their Augmenta patent and continue pursuing their 510(k) clearance, but that hardly mattered, given that they were forbidden to sell the Augmenta until the case was decided.

Meanwhile, through the discovery process, Elist's attorneys learned of the involvement of Run Wang, who still sat on the Penuma advisory board. "That really shocked me," Elist recalled. "Dr. Wang was one of my best confidantes. I shared everything with him. He was from MD Anderson, a highly reputable surgeon and physician. He was president of the SMSNA. It was really an honor just to have him as part of our advisory board."

Elist says Wang had privileged access to information about future plans for the Penuma. He demanded that the Houston urologist cut ties with Cornell and denounce him to the Texas Medical Board. When Wang refused, Elist removed him from the Penuma advisory board and added him as a defendant in the lawsuit. "If there's evidence of collusion with the member of the advisory board for the plaintiff, that is going to be damning evidence for the defendant," Gebru told me. In a sworn statement, Wang denied ever having had knowledge of Elist's trade secrets.

In addition to Wang and Cornell, the defendants now included Richard Finger, Hans Mische, and David Nichols. (Shortly before the trial, the plaintiffs dropped the charges against Clavell.) More defendants meant more discovery requests, more depositions, more legal motions. The plaintiffs hired experts in prosthetic urology and biomedical engineering to write declarations supporting their claims, so the defendants hired their own experts to rebut those claims. Both sides continued to add attorney after attorney in an attempt to gain the upper hand. The trial date was postponed, then postponed again.

The acrimony reached a peak in November 2021, after Cornell published a paper in the journal Sexual Medicine about his Augmenta cadaver tests. Elist was infuriated. His attorneys believed the paper violated Marshall's injunction by disclosing trade secrets and promoting the Augmenta, which the paper described, falsely, as "newly commercially available." Cornell argued that the paper presented research necessary for the Augmenta's 510(k) application, which Marshall had allowed to continue. He also tried to appease the plaintiffs by issuing a correction clarifying that the Augmenta was not commercially available.

In November 2022, after nearly a year of legal arguments over the paper, Marshall found the defendants in contempt of court for violating her injunction. She imposed a $5,000 penalty per day on the defendants until the article was removed from the Sexual Medicine website and ordered them to reimburse Elist for all legal expenses incurred while litigating the journal article.

A few months later, Marshall postponed the trial again, to June 6. A court-ordered mediation session hadn't produced an agreement. Desultory settlement talks had gone nowhere. There was, it appeared, only one entity left that could decide the case: a jury.

"We are confident that our clients will be fully exonerated," an attorney for Cornell and his codefendants said in written statement provided to Texas Monthly the day before the trial was set to begin. "As several doctors and patients have reported, Dr. Elist frequently uses litigation and threats of litigation as a business tactic to distract from the legitimate safety concerns behind his product."

In January, I caught a flight from Houston to Los Angeles, following in the footsteps of Robert Cornell, who had made the same trip five years earlier. Like Cornell, I had been invited to observe James Elist perform a Penuma surgery. After spending the night at a West Hollywood hotel, I took a short Uber ride to the Beverly Hills South Pacific Surgery Center, which occupies a claustrophobic warren of rooms in a glass-and-stone office building a few blocks south of Cedars-Sinai hospital. Waiting for me in the lobby was Jonathan Elist, wearing an upscale-hipster uniform: skinny jeans, white sneakers, and a cable-knit sweater. For several months, Jonathan had been trying to persuade me to write about his father's legal battle. "Welcome to the world of penis!" he greeted me on our first phone call.

I followed Jonathan into a spacious office with floor-to-ceiling windows that looked onto La Cienega Boulevard. Behind an enormous, rococo-style wooden desk sat James Elist, wearing black surgical scrubs with his name embroidered on the breast pocket. After shaking my hand, he told me about the patient he would be operating on today, a man from Long Beach who was in a back room getting pumped full of the anesthetic propofol. Like Marco, the man had a buried penis that made him self-conscious about getting naked. The implant would prevent such shrinkage, Elist said, making his flaccid penis about four inches longer, while adding about two inches of girth. "His wife is very supportive of the surgery," Elist informed me. "She's picking him up today."

Elist excused himself to prepare for the surgery, and Jonathan handed me a set of blue scrubs. After changing, I met Elist, now wearing a surgical cap and mask, just outside the operating room. As we waited for the anesthesiologist to finish preparing the patient, Elist told me about the memoir he had just written, titled Operating With God. He showed me the book's cover image: a surgeon leaning over a patient, bathed in a beam of celestial light. "I’m a very spiritual person," he said, adding that he draws strength not just from the Jewish faith in which he was raised, but also from his study of Christianity and Islam. "I don't care what you believe, as long as you believe."

That faith, he said, has sustained him in the difficult years since Cornell's fateful visit. "I think there's a reason for it," he would later tell me about the Houston urologist's appearance in his life. "Not a personal reason, God's reason." What did he think the reason was? "I don't know," he replied, with a jovial chuckle. "We’ve spent a lot of money, millions of dollars. Very expensive. But sometimes experience is expensive."