Are there any FDA-approved non-surgical methods for increasing penis girth?

1. What the FDA has cleared: a surgical implant, not a needle

The literature and reporting cited identify the Penuma (also marketed or rebranded as Himplant) as an FDA‑cleared silicone penile implant for cosmetic enhancement; that clearance applies to a surgically implanted silicone sleeve, not to non‑surgical injections or devices ^{[1] [2] [3]}. Medical reporting and clinic pages consistently present Penuma/Himplant as the sole product cleared for aesthetic penile enlargement ^{[1] [7]}.

2. Popular non‑surgical options being offered — off‑label, not FDA‑approved for penis use

Clinics market hyaluronic acid (HA) fillers, “penis fillers”/Magic Shot, Bellafill, and autologous fat injections as non‑surgical ways to increase girth; some sites even call their HA techniques “FDA‑approved injections,” meaning the filler material is FDA‑approved for some cosmetic uses elsewhere, but its use in the penis is off‑label and not an FDA approval for penile augmentation ^{[5] [8] [9] [6]}. University and specialty sources state HA injections can increase girth by a mean reported amount (about 2.27 ± 1.26 cm at four weeks in one review) but emphasize off‑label status and short follow‑up ^[4].

3. What major urology guidance says about non‑surgical approvals and evidence

The American Urological Association–linked review plainly states “there are no FDA‑approved options for penile girth enhancement” and flags that no techniques have undergone rigorous, long‑term prospective study to ensure extended safety; it also notes that while HA shows reasonable short‑term durability and safety in some studies, serious complications — including fulminant infection, severe ulceration, disfigurement, and even reports tied to fat graft embolism — have been documented in case reports ^[4].

4. Where the marketing and medical reporting can create confusion

Commercial clinics often highlight that particular fillers (HA, Bellafill) are FDA‑approved for facial or body aesthetics and then advertise their use in the penis, which is legally an off‑label use but can be presented in promotional language as if the product were “FDA‑approved for penis” ^{[5] [8]}. Academic reviews and specialty urology pages counter this by distinguishing product approval for specific indications from off‑label clinical use ^{[4] [9]}.

5. Safety tradeoffs and evidence gaps to weigh

Available reporting shows short‑term gains in girth with HA injections and variable results with fat grafting, but it also documents notable complications and a lack of long‑term, prospective safety data; systematic reviews call for caution and rigorous study before treating these techniques as established standards ^{[4] [10]}. The sources note that autologous fat has documented risks like nodular change and, in a cited fatal case report, fat embolism — underscoring that “non‑surgical” does not mean risk‑free ^{[4] [10]}.

6. Practical takeaways and how to evaluate claims

If you see clinics advertising “FDA‑approved” penile injections, check whether the claim refers to the filler material’s approval for other uses rather than FDA approval for penile augmentation itself; the urology literature explicitly states none of the non‑surgical girth techniques have specific FDA approval for penile use ^{[4] [5]}. For men considering procedures, sources recommend realistic expectations, discussion of off‑label status, and consultation with board‑certified urologists because patient satisfaction measures and long‑term safety remain incompletely studied ^{[6] [4]}.

Limitations: available sources do not mention any newly FDA‑approved non‑surgical penile girth products beyond those summarized above; they focus on HA fillers, fat grafting, and the Penuma/Himplant surgical sleeve ^{[4] [5] [1]}.