Tag: FDA

FDA requests Allergan to recall certain breast implants and tissue expanders from market

Allergan Voluntarily Recalls BIOCELL® Textured Breast Implants and Tissue Expanders, 07.24.2019

“The U.S. Food and Drug Administration today took significant action to protect women from breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) by requesting that Allergan, the manufacturer of a specific type of textured implant, recall specific models of its textured breast implants from the U.S. market due to the risk of BIA-ALCL. Following the agency’s request, Allergan has notified the FDA that it is moving forward with a worldwide recall of their BIOCELL textured breast implant products, including: Natrelle Saline-Filled breast implants, Natrelle Silicone-Filled breast implants, Natrelle Inspira Silicone-Filled breast implants, and Natrelle 410 Highly Cohesive Anatomically Shaped Silicone-Filled breast implants. The recall also includes tissue expanders used by patients prior to breast augmentation or reconstruction, including Natrelle 133 Plus Tissue Expander and Natrelle 133 Tissue Expander with Suture Tabs. The recall helps ensure that unused products are removed from suppliers and doctors’ offices. The agency also issued a safety communication today for patients with breast implants, patients considering breast implants and their health care professionals outlining the known risks and what steps patients should consider when monitoring for symptoms of BIA-ALCL, including swelling and pain in their breasts. The safety communication also lists information about all models and style numbers included in the recall.” …

… continue reading The FDA Takes Action to Protect Patients from Risk of Certain Textured Breast Implants; Requests Allergan Voluntarily Recall Certain Breast Implants and Tissue Expanders from the Market: FDA Safety Communication, 25/07/2019.

Angell on Big Pharma

Some more truth about the pharmaceutical companies

Do pharmaceutical companies corrupt academic research and the clinical trial process ? You bet.

Dr Marcia Angell of Harvard Medical School and the author of The Truth About the Drug Companies talks with EconTalk host Russ Roberts about the impact of pharmaceutical companies on academic research, clinical trials and the political process. Angell argues that the large pharmaceutical companies produce little or no innovation and use their political power to exploit consumers and taxpayers. Reference.

Current uses of BPA are safe – Not

Getting a Clear View : Lessons From The CLARITY-BPA Study, 2019

Listen to Dr. Laura Vandenberg, Associate Professor and Graduate Program Director in the Department of Environmental Health Sciences in the University of Massachusetts Amherst School of Public Health and Health Sciences, analyses The CLARITY-BPA study. Reference.

Bisphenol A (BPA) is produced in high volume and is still in use in a variety of products globally. Many independent, academic studies have demonstrated an association between exposure to BPA and multiple adverse health outcomes including endocrine-disrupting end-points. However, studies included in regulatory risk assessments have been cited as evidence that current uses of BPA are safe.

The U.S. National Institute of Environmental Health Sciences (NIEHS), the National Toxicology Program (NTP), and the Food and Drug Administration (FDA) sought to address these disparities in scientific findings and put together the Consortium Linking Academic and Regulatory Insights on BPA Toxicity, otherwise known as CLARITY-BPA.

Depression pills increase suicides in adults too

Newer-Generation Antidepressants and Suicide Risk in Randomized Controlled Trials: A Re-Analysis of the FDA Database

“In this re-analysis of the FDA safety summaries, we found evi-dence that the rate of (attempted) suicide was about 2.5 times high-er in antidepressant arms relative to placebo. Our findings thus conflict with the work by Khan et al., who based their effect estimates on PEY rather than the number of patients. When haz-ards are not constant over time, PEY is inappropriate and may obscure a true adverse drug effect, since (attempted) suicide most-ly occurs shortly after treatment initiation and not during con-tinuation or maintenance phases [6, 9]. Adverse-event risk should therefore be calculated based on the number of patients exposed to treatments rather than PEY, and this is also the approach ap-plied by the FDA. Thus, when based on the number of patients randomized rather than PEY, the data presented herein suggest that antidepressants significantly increase the suicide risk in adults with major depression. Further research is required to establish whether the increased suicide risk observed in RCT generalizes to real-world practice, and we acknowledge that suicide attempts constitute just one aspect of a thorough risk-benefit evaluation.”

Read Newer-Generation Antidepressants and Suicide Risk in Randomized Controlled Trials: A Re-Analysis of the FDA Database, on karger, June 24, 2019.

Image credit Ian Espinosa.

FDA bans sales of transvaginal mesh

FDA takes action to protect women’s health, orders manufacturers of surgical mesh intended for transvaginal repair of pelvic organ prolapse to stop selling all devices

April 16, 2019 – The U.S. Food and Drug Administration today ordered the manufacturers of all remaining surgical mesh products indicated for the transvaginal repair of pelvic organ prolapse (POP) to stop selling and distributing their products in the U.S. immediately. The order is the latest in a series of escalating safety actions related to protecting the health of the thousands of women each year who undergo surgery transvaginally to repair POP.

The FDA has determined that the manufacturers, Boston Scientific and Coloplast, have not demonstrated a reasonable assurance of safety and effectiveness for these devices, which is the premarket review standard that now applies to them since the agency reclassified them in class III (high risk) in 2016. As part of the 2016 reclassification, manufacturers were required to submit and obtain approval of premarket approval (PMA) applications, the agency’s most stringent device review pathway, in order to continue marketing their devices in the U.S. The companies will have 10 days to submit their plan to withdraw these products from the market.

… continue reading the FDA press announcement.
Read the meshCNN press release. Image credit leakylily.

In the UK

 

Hidden FDA Reports Detail Harm Caused By Scores Of Medical Devices

The Food and Drug Administration has let medical device companies file reports of injuries and malfunctions outside a widely scrutinized public database, which leave doctors and medical sleuths in the dark

Kaiser Health News senior correspondent Christina Jewett explains how she investigated a Food and Drug Administration database where medical device makers report malfunctions and patient injuries, skirting the public record. Because the cache of information is buried deep within the agency, it’s often hard for physicians, researchers and patient safety advocates to access the information.

US FDA Breast Implant Postapproval Studies

Largest-Ever Study Shows Silicone Breast Implants Associated with Rare Diseases

In the largest study of long-term safety outcomes for patients with breast implants, researchers at The University of Texas MD Anderson Cancer Center have found that silicone implants are associated with some rare diseases, autoimmune disorders and other conditions.

Abstract

Objective:
To analyze the long-term safety and efficacy outcomes of patients with breast implants.

Summary Background Data:
Research is ongoing regarding the safety of silicone breast implants. Despite the number of patients with breast implants followed by United States Food and Drug Administration large postapproval studies (LPAS), this database has not been thoroughly analyzed or reported.

Methods:
This is a multicentered, cohort study. LPAS prospectively monitor long-term implant-related outcomes and systemic harms for silicone/saline implants from 2 manufacturers (Allergan and Mentor) placed for primary/revision augmentation/reconstruction. Systemic harms, self-harm, and reproductive outcomes are compared with normative data. Implant-related complications are analyzed by implant composition and operative indication in the short and long terms.

Results:
LPAS data includes 99,993 patients, 56% of implants were silicone for primary augmentation. Long-term magnetic resonance imaging surveillance is under 5%. Compared with normative data, silicone implants are associated with higher rates of Sjogren syndrome (Standardized incidence ratio [SIR]8.14), scleroderma (SIR 7.00), rheumatoid arthritis (SIR5.96), stillbirth (SIR4.50), and melanoma (SIR3.71). One case of BI-ALCL is reported. There is no association with suicide. In the short term, rupture is higher for saline (2.5% vs. 0.5%, P < 0.001), and capsular contracture higher for silicone (5.0% vs. 2.8%, P < 0.001). At 7 years, reoperation rate is 11.7% for primary augmentation, and 25% for primary/revision reconstruction. Capsular contracture (III/IV) occurs in 7.2% of primary augmentations, 12.7% primary reconstructions, and is the most common reason for reoperation among augmentations.

Conclusions:
This is the largest study of breast implant outcomes. Silicone implants are associated with an increased risk of certain rare harms; associations need to be further analyzed with patient-level data to provide conclusive evidence. Long-term safety and implant-related outcomes should inform patient and surgeon decision-making when selecting implants.

Reference. Press release.

Big pharma partnering with influencers to sell drugs, medical devices

The latest Instagram influencer frontier? Medical promotions

Abstracts

“By enlisting influencers to market their health care products amid a stream of Facetuned photos, pharmaceutical and biotechnology companies co-opt narratives that give social media users a sense of how healthy they can be, if only they had this product.”

“Social media enables its users to connect over shared interests, locations, and even illnesses. Using this formula, health care companies locate potential influencers who can use these commonalities to reach and build trust with an audience.”

“One wonders why a company would assume the risk of misinformed patients, as they are responsible for what their paid endorsers say. The reason is simple: One in three consumers in the US consult social media for health-related matters. “

Read The latest Instagram influencer frontier? Medical promotions, on vox, Feb 15, 2019.

Why nobody knows what’s really going into your food

Massive legal loophole means companies can add new ingredients to foods with no government safety review

The industry can declare on their own that added ingredients are safe without ever consulting the Food and Drug Administration about potential health risks.

References : publicintegrity and belowthesaltnews, 2015.

How one scientist averted a national health crisis

Dr Frances Oldham Kelsey : 20th-century American heroine for her role in the Thalidomide case

In 1960, Frances Kelsey was one of the Food and Drug Administration’s newest recruits. Before the year was out, she would begin a fight that would save thousands of lives — though no one knew it at the time.

  • Andrea Tone explains how Kelsey was able to prevent a massive national public health tragedy by privileging facts over opinions, and patience over shortcuts.
  • Video published on 7 June 2018 by TED-Ed.
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