A revolutionary implant gives men a larger penis, but some say it's left them deformed and in excruciating pain

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A revolutionary implant gives men a larger penis, but some say it's left them deformed and in excruciating pain
Matt, a contractor in the western US who received a Penuma implant in 2019.Niko Krivanek for Insider

A urologist wants to make his penis-enlargement implant as common as breast implants. Some men who've gotten it say it's left them deformed and in excruciating pain.

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Matt liked his penis. The length was fine. The girth was awesome. But it curved. Not like a scimitar or letter C; just a gentle little bend. It bugged him.

"I wanted it to be straight," said Matt, a contractor in his 40s who lives in the western US. He worried the curve was hurting his girlfriend during sex.

After an online search, Matt diagnosed himself with Peyronie's disease, a condition that causes serious curvature of the penis. It affects about one in 10 men in the US.

That led him to Penuma, a semisolid silicone implant that's surgically inserted into the penis shaft just under the penile skin. The device retracts when the penis is flaccid and emerges when it's erect.

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While it's not intended for Peyronie's patients, the implant does help straighten out the penis in patients with mild to moderate curvature. Matt was intrigued.

Penuma was invented in the early 2000s by Dr. James Elist, an Iranian American urologist. Originally, he used it on patients whose members had narrowed after they received a prosthesis for erectile dysfunction. He soon discovered that Penuma not only maintained preoperative girth and length for patients with ED but also added a bit more flaccid length and flaccid and erect girth to what they had before the prosthesis.

In other words, it could help men who wanted bigger dicks. And there were wagonloads.

My patients are so happy ... One of them says, 'I go to the gym more often and I intentionally drop my towel so they can see what I have.' Dr. James Elist, urologist and inventor of Penuma

In 2004, after getting general clearance from the Food and Drug Administration, Elist began offering Penuma as a penile-enhancement device. In 2017, the FDA gave Penuma — which comes in sizes L, XL, and XXL — a 510(k) clearance, allowing the device to be commercially distributed and used for the cosmetic correction of penile soft-tissue deformities. In 2022, the agency further clarified that Penuma was intended for penile augmentation.

Since 2004, nearly 5,000 men have gotten Penuma, and Elist has trained 17 other urologists to implant it. In a 2018 study sponsored by International Medical Devices, the Elist-owned company that distributes Penuma, the implant increased midshaft circumference in 400 men by an average of 56.7%.

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"I thank God that I was able to bring something new," said Elist, 73, who believes that Penuma will one day become as common as breast implants.

Matt, the self-diagnosed Peyronie's sufferer, couldn't find any negative reviews about the procedure, and he liked that it was reversible. If something went awry, he thought, the implant could be easily removed, and his organ would return to its presurgical state.

Sure, the $16,000 price tag was hefty, and his insurance didn't cover it. But that didn't dissuade him. "People invest in redoing their decks," he said of his mindset at the time. "I'm investing in my body."

But a few weeks after receiving Penuma in 2019, Matt said, he began to experience terrible pain, followed by a seroma — fluid collecting under the skin — and significant swelling. His penis throbbed like a metronome gone haywire.

Elist and his team told Matt it was all normal and the swelling would decrease over time. Matt says it didn't.

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Ultimately, Matt's penis was curved even worse than it had been before, "like an orange peel in the sun," he said. "I had to push it into the toilet to go pee."

Penile implants and other forms of penis augmentation are booming, despite clear risks

The penile-implants market is expected to hit $640.5 million worldwide by 2027, which researchers largely attribute to men seeking to address erectile dysfunction. (ED is on the rise as many countries' populations age; it can also be a lingering consequence of a COVID-19 infection.)

While ED drives the most interest in penile implants, lots of guys are insecure about their size, even if they're statistically normal. Often, they don't know what normal is, thanks to locker-room shower comparisons and easy access to porn.

"If you ask men what the average-sized penis is, they have no idea," said Dr. William Brant, a Salt Lake City urologist who specializes in penis surgery, including fixing men who've had augmentations they've regretted. "They all guess about 2 inches longer than it actually is."

A revolutionary implant gives men a larger penis, but some say it's left them deformed and in excruciating pain
Erectile dysfunction can be treated surgically with a penile prosthesis.BSIP/UIG/Getty Images

For the record: The average penis is about 3.6 inches flaccid, with an average flaccid girth of 3.7 inches. When erect, it's about 5.1 inches, with an average circumference of 4.5 inches. Micropenises, which have a stretched penile length of about 3 2/3 inches or less, are rare.

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For those seeking further enhancement, enlargement surgery, also known as phalloplasty, has never been foolproof. And there isn't one accepted method.

Some surgeons cut the suspensory ligament in the groin to make the penis look longer. Others inject collagen gel into the penis, or fat from the patient, a cadaver, or fetal calf tissue. Still others, mostly plastic surgeons, inject dermal fillers and hyaluronic acid. Then there are semirigid and inflatable prostheses.

Each method has its downsides. Fat injections, advised against by both the Urology Care Foundation and the American Urological Association, can get lumpy. So can fillers, which can cost as much as $100,000 for a series of treatments. Prostheses can cause, among other issues, infections and internal erosion, the Mayo Clinic reports.

As a result, some experts warn against all forms of elective penile enlargement. The Mayo Clinic notes that penis-enlargement surgery is "experimental" and "is typically reserved for men whose penises don't function because of a problem present at birth or an injury."

"The penis has to stretch," said Dr. Joel Gelman, a board-certified urologist in Los Angeles who coauthored a study that found penile- and scrotal-enhancement surgery could lead to deformity and functional compromise in men. He refuses to do penile enlargements of any type.

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Elist agrees that the Mayo team is "correct" about the high risks of fat injections, acid injections, and cutting the suspensory ligament. He said he'd had firsthand experience seeing patients with damage from those procedures. But he believes Penuma is different.

"The FDA has reviewed and cleared Penuma four times over nearly 20 years," Elist said. "Some of the most well-reputed prosthetic urologists use Penuma on a regular basis, including professors of urology from Rush University and Mount Sinai."

Penuma is marketed as easy, safe, and removable — but the company also discloses real risks

Penuma is inserted subdermally through an incision in the scrotal area and connected to a portion of the penis shaft within the body using polyester mesh or hidden sutures. It's promoted as a brief outpatient procedure, typically lasting 45 to 60 minutes.

"My patients are so happy — when I remove the dressing, they have tears in their eyes," Elist said. "Some of them used to go to the gym and hide behind towels because their penis was retracting like a turtle. Now one of them says, 'I go to the gym more often and I intentionally drop my towel so they can see what I have.'"

But one 2019 case study of an unhappy Penuma patient points out the implant can have major risks. "This cosmetic procedure may have under-reported rates of side effects, including infection, chronic pain, iatrogenic ED, and penile disfigurement," the report concludes.

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Insider spoke with 14 men who received the Penuma implant. Nine said they experienced issues such as massive swelling, erectile dysfunction, and excruciating pain in their penises.

A New York man, who had the surgery in January 2021, described it as the worst mistake of his life. The postsurgical pain was so bad, he said, that he fantasized about "cutting my dick off."

Penuma patients tell Insider they've suffered in silence

In interviews with nine dissatisfied Penuma recipients, all declined to use their full names — partly because they were afraid of being sued and partly because, well, penis-enlargement surgery. None of them wanted to broadcast their enhancements in a public forum.

The New York man said he got Penuma as an early 40th birthday present, because as a 6-foot-7 gay man, "people expect me to be hung." Now, "there's this foreign object in a very sensitive part of the body, and the body is pissed about it," he said. "It doesn't bend. It feels like a dildo."

His penis no longer hangs the way it used to. "Imagine the head of the penis is a clock and they put the implant in at 12. Well, mine is at 11 or 10."

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Before getting Penuma last May, James, a 36-year-old Nevada trader, had an average-size penis — about 5 1/4 inches when erect. But he wanted to be a little bigger. After reading about Penuma in GQ and watching video of the surgery online, he said, he felt that he was in good hands with Elist.

But immediately after the surgery, James said, he was overcome by excruciating pain and major swelling. When he woke up with his usual morning erection, it felt as if someone had "jammed a red-hot ice pick down my urethra." He said Elist's office told him that was normal.

Three days after the procedure, James had his bandages removed; he noticed protuberances bulging out both sides of his penile shaft. He said Elist's office told him this, too, was normal. Then he discovered he had zero sensation at the top of the shaft when erect. He pinched himself, hard, just to make sure. Nada.

James officially panicked when a seroma grew so big that he developed what's colloquially called "penguin dick" (picture a disproportionately huge shaft with a tiny little head).

In September, James had Brant, the Salt Lake City urologist who fixes penile augmentations, remove the implant. After the removal, he discovered his penis had reduced in size, to only 3 inches when erect. "That destroyed me," he said. "I went to a dark place."

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Thanks to a penile stretcher, James' penis is now about 3.5 inches when erect. But sex is problematic, he said, because of a painful "drastic upward curve" and scar tissue left over from the surgery. (Elist declined to comment on James' case or other specific patient outcomes, citing confidentiality issues.)

A self-described 'model patient' experiences painful complications

After his self-diagnosis with Peyronie's, Matt traveled to Elist's Beverly Hills, California, office in September 2019. Before even meeting with the doctor, he forked over a deposit of $1,500.

He was handed a consent form as thick as a porterhouse steak. It informed him that potential complications included seromas; penile retraction in both erect and flaccid states; and impotence. The forms also required him not to disclose any aspects of the procedure or its effects. If he did, he could face legal action.

A revolutionary implant gives men a larger penis, but some say it's left them deformed and in excruciating pain
After surgery, Matt followed the doctor's orders: No sex, no masturbation, diligent use of a compression sock that fit snugly around the penis.Niko Krivanek for Insider

Matt hesitated but ultimately signed the forms. Had he wanted to back out, he said, he would have lost the $1,500.

"They ask that you pay the deposit prior to signing the consent form, so if you refuse, you're forfeiting the deposit," he said.

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(A spokesperson for Elist disputed Matt's claims, saying that patients are informed of Penuma's risks in advance of making a deposit. As long as they don't no-show, they can get a refund if they choose not to move forward. The spokesperson said the restrictions on disclosure were intended to disincentivize doctors who have no experience with the device; asked for comment on how, he did not elaborate further.)

After signing the forms, Matt answered a slew of written questions:

How would you rate your self-esteem, with respect to the size of your penis? (Medium)

How would you rate your self-confidence in attempting sexual contacts/affairs with sexual partners, with respect to the size of your penis? (High)

How often does the size or appearance of your penis currently lead you to avoid situations or activities? (Never)

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"I wrote that I feel confident, but there's just this one thing that I want to adjust," Matt said.

After a short meeting that "felt like four minutes," Matt decided to move forward. (Elist's spokesperson disputed Matt's characterization of the time frame, saying that he "spends a considerable amount of time with each patient.")

The next day, Matt had the surgery, which lasted about an hour. Afterward, he followed the doctor's orders: No sex, no masturbation, diligent use of a compression sock that fit snugly around the penis.

"I was an absolute model patient," he said. "I left it alone and wrapped it like a swaddling baby. I made sure that I changed the dressings often. I kept everything in the compression wrap." His girlfriend, a registered nurse, confirmed to Insider that she double-checked his handiwork.

Matt was instructed to stay in touch with Elist's office for eight weeks, which he said he did other than a two- to three-week stint early on when he was out of the country and likely to experience spotty reception. ("I asked them before I left if they were OK with that gap, and they verbally said yes," he said.)

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Complications hit around week four. In an October 4, 2019, email to Elist, Matt wrote that "when I get random erections at night, the blood flow combined with the additional fluid swelling is overwhelmingly painful."

"Some swelling is common and expected after surgery," Elist responded via email. "It may feel like a water balloon because fluid is trapped under the skin, but this will be reabsorbed as you continue to heal."

It did not.

In February 2020, five months after the initial surgery, Matt saw Elist in person. He said the urologist told him he could use an "upgrade" to a newer replacement implant. Matt declined, infuriated. Upgrade? This wasn't a bump up to business class.

Instead, he had Elist remove the implant altogether. But new complications arose.

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To hold the implant in place, Elist had inserted a Covidien polyester mesh that's typically used for hernia surgery. As a result, Matt said, scar tissue had formed over his penis, constricting blood flow and preventing it from stretching and expanding. During his visit, Matt recalled, Elist referred to it as a "capsule" and said it was normal and healthy.

A revolutionary implant gives men a larger penis, but some say it's left them deformed and in excruciating pain
Matt said Dr. James Elist offered an "upgrade" to a newer replacement implant — which he declined, infuriated.Niko Krivanek for Insider

Matt balks at the euphemism. "That's a wonderfully candy-coated way of saying there's going to be fibrous scar tissue inside you," he said. "It's like saying a head-on collision is 'two cars kissing.'"

As Matt soon learned, the FDA had issued an info sheet about hernia repair with mesh. The procedure's most common adverse effects, the agency noted, included pain, infection, "mesh migration and mesh shrinkage (contraction)."

Matt said none of those had come up in his discussions with Elist, nor in any of the documents he signed. (Elist disputes this.) Elist himself recently stopped using mesh in Penuma surgeries, saying the newest generation of the device didn't require it.

Penuma has numerous online critics — and its inventor has threatened legal action against some of them

Frantic, Matt did a Google search and stumbled upon PhalloBoards, a kind of Yelp for penis-enlargement procedures. There, he found the information about the mesh — and negative posts about Elist.

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From anonymous PhalloBoards posters, Matt learned that two men had filed a complaint against Elist with the California Medical Board in 2018. One alleged that Elist had deviated from the "standard of care" by giving him a larger implant five months after removing his first, infected implant.

The other said Elist had improperly placed the implant and surgical mesh inside him, which compressed his urethra. After another doctor removed the implant, he said, his penis decreased in length by 2.5 inches. (Subsequent procedures restored some of it.) He also claimed Elist failed to track his medical records accurately.

The medical board ultimately dismissed all of but one of the claims, issuing a public reprimand against Elist in July 2019 for failing to maintain "adequate and accurate medical records" in the care and treatment of the second patient. Elist was ordered to enroll in a medical record-keeping class, which his spokesperson told Insider he completed.

Elist had also been licensed to practice in New York since 1989, though he never actually practiced there. In April 2020, the New York State Board for Professional Medical Conduct reprimanded, censured, and fined him $500 for the same offense.

He's now precluded from practicing medicine in the state or in any setting where his practice is based solely on his New York medical license. (Elist's spokesperson said he voluntarily requested to drop his New York license, as he had never used it and didn't even realize he still had it. The New York State Department of Health declined to comment on the case, saying it's legally barred from discussing details of an investigation or prosecution.)

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A second accusation against Elist with the California Medical Board, filed in 2021 and most recently amended in 2023, is pending. The lead complainant is a Massachusetts man who won a 2013 contest to receive penile-enhancement surgery in exchange for participating in a documentary about the "history of male sexuality and genitalia enhancement."

I've seen this thing erode through the skin, I've seen it fragment, I've seen it curl. Dr. Mark P. Solomon, a plastic surgeon who says he's removed more than 50 Penuma devices

In the complaint, the man says he traveled to California and met with Elist, who diagnosed him with a tight suspensory ligament. He also alleges that Elist diagnosed him with penile dysmorphic disorder, despite the lack of a formal psychological evaluation or referral to a mental-health professional. Elist performed the Penuma procedure the same day.

After the surgery, the man said in the complaint, the implant detached from the base of his penile head and began to move around the circumference of the shaft of his penis. He sent photos to Elist, who the complaint says told him the implant would need to be removed — at a cost of $3,500 to cover anesthesia and the surgery center. The man ultimately had another doctor remove the implant.

In the amended 2023 complaint, eight additional patients — including Matt — accused Elist of misdiagnosing them with PDD or low self-esteem without proper psychological evaluations; minimizing their postsurgical complaints of swelling, pain, curvature, and loss of sensation; and maintaining inaccurate records, among other concerns.

At least two claimed that Elist paid them $5,000 to remove negative posts about him and Penuma from social media, specifically PhalloBoards. The complaint notes that it is "unethical for a physician to offer to compensate a patient in exchange for removing comments on social media regarding the care and treatment received from the physician."

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The men also allege that Elist wouldn't remove their implants unless they signed "release of claims" forms that relieved Elist from liability. Elist has not formally responded to the accusation, but his spokesperson said he intended to do so and was "confident that the action will be withdrawn, and the issue resolved favorably," adding: "The accusations are false."

Fearful of lawsuits from Elist, several doctors contacted by Insider declined to speak about him on the record. Through his attorneys, Elist has sent cease-and-desist demands to two critics of the Penuma procedure, both of which were viewed by Insider.

Dr. Mark P. Solomon, a board-certified plastic surgeon in Philadelphia and Beverly Hills, has published and lectured on complications from penis-enhancement surgery. He received a cease-and-desist demand from Elist alleging defamatory statements on his website.

"They will tell you they have hundreds of happy patients, but I see the numerator, not the denominator," said Solomon, who estimates he's removed 50 to 100 Penuma devices. "I've seen this thing erode through the skin, I've seen it fragment, I've seen it curl. I've seen the scar capsule from it cause nerve compression, so the patient doesn't have nerve sensation at the head of the penis."

Removing the implant may cause new issues

Penuma is marketed as being removable. But parting ways with the implant may cause new problems, according to allegations in a current class-action lawsuit against Elist.

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In the complaint, filed in May 2022, a 22-year-old San Antonio man alleges that before undergoing the procedure he had a "normal, healthy penis" with "no soft-tissue deformity of the penis, nor any urological problems of any kind."

According to the complaint, once the man received Penuma, two corners began sticking out, eventually puncturing the skin. The man alleges that he couldn't sleep on his back or stomach, or bend down to tie his shoe, without pain. He woke up multiple times in the middle of the night with painful erections; he got no sleep for at least three months.

A reconstructive urological surgeon in Austin ultimately removed the device. But the man said he continued to suffer complications, including penile retraction, loss of sensation, and scarring. In the complaint, the man says he no longer has feeling on the top of the shaft of his penis and still feels pain at the bottom of the shaft.

In an emailed statement, the man's lawyer, Amy E. Tabor of the Houston-based Caddell & Chapman, said she was "committed to pursuing claims that false representations in Penuma's marketing misled thousands of men to purchase the Penuma device and procedure."

Elist's lawyers have filed a motion to dismiss the suit, which is pending. "This lawsuit lacks merit," Jennifer Stevenson, an attorney for International Medical Devices, said in a statement.

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"I had not ever been told that it was reversible 'with conditions,'" said Kyle, 31, a software engineer from Colorado who received Penuma in August 2019. About 2 1/2 years later, he said, his penis began to hurt during sex. He awoke one morning to serious inflammation, which ultimately required two trips to California to have Elist drain the swelling.

Kyle had his implant removed by Brant in March 2022 and spent months doing stretching exercises to regain the 2 inches of penile length he lost from the removal. He said his sensation had almost all returned but he still had a strand of scar tissue running along the top of his penis.

"I wish I would have known more about the risks of removal," he said. "Everyone talks about the risks of it going in, but there's not a lot of emphasis on the risk of taking it out."

'There is no procedure without any complications'

While Elist acknowledges that he has some less-than-thrilled patients, he believes they're the exception, not the rule. He attributes most complications to patients' failure to follow his postoperative instructions and says the consent form makes the risks very clear.

"Even if there are 300 removals, I'm very appreciative of God and thankful that out of 5,000 or 6,000, I've had only 300 unhappy patients in 15 years," he told Insider. "There is no procedure without any complications."

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"At the end of the day, there are going to be people whose bodies don't react well to having something implanted," agreed Dr. David Josephson, a board-certified urologist in Los Angeles who was provided to Insider for comment by IMD. (He's unaffiliated with the company and doesn't do Penuma surgeries but has rented office space from Elist in the past.)

One problem, Josephson said, is that men often can't wait the required length of time before checking out their new equipment. "It's like this big toy, and they want to take it out for a ride and they do these things they're not supposed to do."

Elist believes that his critics are unfairly biased and that the backlash against phalloplasty stems from prejudices people have against men surgically altering their appearance, which is considered less culturally acceptable than it is for women.

Elist's son, Jonathan, who's IMD's chairman and also ran for the US Senate in California last year, noted that Dr. F. Brantley Scott, the inventor of the penile prosthesis for ED, faced similar critiques before his invention was accepted.

There's a reason they call it your 'manhood.' It becomes part of your self-identity. When that becomes mutilated, men go into a very dark place very fast. Matt, a patient who experienced complications from Penuma

Insider talked to five Penuma recipients who were enthusiastic about their decision, all of whom were provided for comment by IMD. One of them, a 23-year-old named Sergio Ceja, was downright giddy.

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"It was an alpha thing," said Ceja, an aviation-mechanic student at a trade school in Clearwater, Florida, who received Penuma in August 2020. After the surgery, he felt sore, but it was tolerable. And the response has been amazing, he said.

"The girth is insane," said Ceja, who paid $16,000 for the procedure. "I told a friend, 'Dude, you gotta get this.' Life has been very cool since I've had it. I never went skinny-dipping before. Now I do."

"I'm so much more free-spirited when it comes to shit like public sex," he added. "The girls I'm having sex with are guys' dream girls. I think it's definitely a confidence thing."

Elist's own 2018 study found that 81% of subjects had "high" or "very high" levels of satisfaction two to six years postoperation. Another positive study, published in 2022, corroborated the 2018 findings with further reports of high patient satisfaction. Its authors were the board-certified urologist Steven K. Wilson, who's a paid consultant for IMD (but was not paid to write the study), and Anton-Luigi Picazo, Elist's former medical and research assistant.

In their respective studies, both Elist and Wilson disclose their financial connections to IMD. "All the papers in prosthetic urology are written by doctors who have disclosures, because we are the ones with the patient experiences," Wilson told Insider via email. "I have written many papers on all the other implants, so while it seems odd to an outsider, I guess it is just a fact of life in this tiny subspecialty." (Picazo didn't respond to a request for comment.)

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But Brant is unimpressed.

"There are a variety of biases inherent in studies, and it is important to have a host of robust studies in which investigators do not have any skin in the game," he said. "For this reason, patients and providers should always take early studies with a grain or a block of salt."

Willingness to 'crawl on broken glass to have this guy stopped'

A revolutionary implant gives men a larger penis, but some say it's left them deformed and in excruciating pain
Matt said it took "a fortune and years of despair" to fix his penis.Niko Krivanek for Insider
Through PhalloBoards and Reddit threads, Matt has now spoken with numerous men who say they regret receiving Penuma.

"There's a reason they call it your 'manhood,'" Matt said. "It becomes part of your self-identity. When that becomes mutilated, men go into a very dark place very fast."

After his own disastrous experience, Matt flew around the country trying to find a doctor to help him. He said he'd had seven pricey correctional procedures. His penis looks "OK," he said, and the original curvature is gone.

"It looks like it's finally back to normal and it works great now, but it took a fortune and years of despair to get here," he said.

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He said he's still furious with himself and Elist, and he's planning to pursue legal action. If it were up to him, he said, both Penuma and Elist would be banned.

"I wouldn't give a shit if I had to pay money and crawl on broken glass to have this guy stopped," he said.

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