Repair of post-bariatric surgery, recurrent, and de novo hiatal hernias improves bloating, abdominal pain, regurgitation, and food intolerance.

BACKGROUND: Post-bariatric surgery hiatal hernias are associated with a cluster of symptoms, including bloating (nausea/vomiting or fullness), abdominal pain, regurgitation, and food intolerance or dysphagia (BARF). OBJECTIVES: To report the short-term outcomes of repairing post-bariatric surgery hiatal hernias in patients with BARF. SETTING: Large, multispecialty group practice with university affiliation. METHODS: We reviewed the records of all consecutive patients who underwent repair of post-bariatric surgery hiatal hernias (2012-2020). Data are shown as means ± standard deviations. RESULTS: We repaired hiatal hernias in 52 patients (age, 57 ± 10 yr), 4 ± 3 years post sleeve gastrectomy (SG; n = 27), 11 ± 6 years following Roux-en-Y gastric bypass (RYGB; n = 24), and 11 years post duodenal switch with SG (DS-SG; n = 1). Diagnoses were made by upper gastrointestinal contrast study (80%), computed tomography (70%), and/or endoscopy (56%). Hernias in patients with SG were repaired by a posterior cruroplasty after reducing the neo-stomach into the abdomen (n = 11 SG patients; n = 1 DS-SG patient) or converting the SG to RYGB (n = 16). All 24 RYGB patients underwent hernia repair similarly. At 12 ± 10 months of follow-up, dysphagia or regurgitation improved in >80% of patients; nausea, vomiting, or abdominal pain improved in 70% of patients; and heartburn persisted in 56% of patients. Subsequent recurrent hernias that required operative repair developed in 3 patients. CONCLUSIONS: Hiatal hernias containing the neo-stomach present earlier after SG than RYGB. The diagnosis can be made with a combination of imaging studies and endoscopy. Repair of post-bariatric surgery hiatal hernias markedly improves symptoms of BARF in most patients.

The use of stratefied sampling of blend and dosage units to demonstrate adequacy of mix for powder blends.

In response to concerns expressed by applicants regarding inconsistent policies in establishing blend uniformity acceptance criteria to demonstrate adequacy of mix, the FDA Office of Generic Drugs (OGD) issued the draft document Guidance for Industry, ANDAs: Blend Uniformity Analysis (August 1999). Both generic and innovator pharmaceutical companies raised a number of concerns following the publication of this document. As a result, the Product Quality Research Institute (PQRI) Blend Uniformity Working Group (BUWG) was established in February 2000. One of the primary goals of this group was to draft a scientifically based alternative to the OGD document. The resulting recommendation addresses both FDA and industry concerns by substantially enhancing product quality assurance without increasing regulatory burden. The PQRI BUWG recommends that these blend and dosage unit uniformity requirements be administered uniformly throughout the industry. PQRI submitted the following recommendation to the FDA on December 31, 2002, providing the Agency with an alternative strategy to consider when drafting future regulatory policy to assess blend and dosage unit uniformity.