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Journal of Plastic, Reconstructive &... Jun 2012Concerns about the durability of silicone breast implants manufactured by Poly Implant Prothèse (PIP) have been expressed for several years prior to their formal... (Comparative Study)
Comparative Study
INTRODUCTION
Concerns about the durability of silicone breast implants manufactured by Poly Implant Prothèse (PIP) have been expressed for several years prior to their formal withdrawal from the market in March 2010. Although precise details of what elements were at fault remain unclear, concerns have been raised about both the elastomer and the filler gel. Media speculation has focussed on device safety, longevity and, recently, a possible association with lymphoma, specifically anaplastic large cell lymphoma (ALCL). There is however, no actual data concerning these implants with which to guide and inform when concerned patients seek advice.
PATIENTS AND METHODS
PIP mammary prostheses were used by the senior author for both primary and revision breast augmentation (BA) during the period January 2000-August 2005. A database of patients was constructed and attempts made to contact each patient offering a free consultation and referral for ultrasound scan (USS). Chief outcome measures included secondary surgery, the implant rupture rate and time to rupture.
RESULTS
453 consecutive patients with PIP devices were identified. Of this number 30 had already undergone implant exchange for a variety of reasons. 180 (39.7%) could not be contacted and 19 had undergone explantation elsewhere, including the NHS. Of those who could be contacted, 47 declined consultation as they had no concerns. 97 had neither clinical signs nor radiographic evidence of implant rupture and elected to remain under regular review. At the time of writing, 38 have undergone implant exchange after ultrasonographic indication of rupture and the overall patient rupture rate for the PIP implant is 15.9-33.8%. This cohort correlates reduced implant longevity with each successive year from 2000 and no cases of ALCL have been diagnosed.
DISCUSSION
Long-term studies such as this are difficult to undertake for a number of reasons as they place a significant additional burden of resources on a practice. They are, however, essential from an industry perspective both for the provision of information and supporting audit and professional standing. Being only a single-handed practice, this initial study is the tip of an iceberg that may affect 40,000 women in the UK with PIP implants, but it does provide some hard data with which to guide our patients. It is also believed to be the first independent product recall study in aesthetic breast surgery.
Topics: Adolescent; Adult; Age Factors; Aged; Breast Implantation; Breast Implants; Databases, Factual; Device Removal; Female; Humans; Incidence; Medical Device Recalls; Middle Aged; Postoperative Complications; Prosthesis Design; Prosthesis Failure; Reoperation; Retrospective Studies; Risk Assessment; Rupture, Spontaneous; Silicone Gels; United Kingdom; Young Adult
PubMed: 22405818
DOI: 10.1016/j.bjps.2012.02.019 -
Journal of the American Pharmacists... 2022Ensuring the quality and safety of the pharmaceutical supply chain is a key policy focus vital to protecting the public from harmful or potentially harmful medications....
BACKGROUND
Ensuring the quality and safety of the pharmaceutical supply chain is a key policy focus vital to protecting the public from harmful or potentially harmful medications. Although the Food and Drug Administration (FDA) reports the number of recalled products per fiscal year and categorizes recalls based on product type and recall classification, these reports do not distinguish between manufactured and compounded products.
OBJECTIVES
This research aims to categorize drug recalls based on the reason for recall and then to compare this reason between manufacturers and compounders.
METHODS
All publicly available drug recall data were downloaded from the FDA Data Dashboard website on January 24, 2021. Two reviewers independently categorized the recalling firm, distribution pattern, and reason for recall, and a third reviewer resolved all conflicts. Descriptive statistics were reported for recall event classification, distribution, and recall reason for the full sample. Chi-square test of independence was used to assess categorical variables by facility type (manufacturer or compounder) as well as by event classification (class I, II, or III). A subgroup analysis was performed focusing on class I level recalls only, representing the most serious recall, and similar statistical procedures were performed.
RESULTS
From June 8, 2012, to January 24, 2021, there were 12,343 drug products recalled; 6771 were from a manufacturer, and 5572 were from a compounder. Most recalls from both compounders and manufacturers were class II recalls with products being distributed to multiple states. Sterility assurance was the predominant reason for recall among compounders, whereas product quality was the most frequent recall reason for manufacturers. There were statistically significant differences in class I recalls between compounders and manufacturers and recall reason compared across recall classification.
CONCLUSION
There was a statistically significant difference in the reason for a drug to be recalled, the distribution level, and the product class for manufactured and compounded products.
Topics: Drug Recalls; Humans; United States; United States Food and Drug Administration
PubMed: 35422393
DOI: 10.1016/j.japh.2022.03.010 -
MAbs 2012Therapeutic monoclonal antibodies (mAbs) are currently being approved for marketing in Europe and the United States, as well as other countries, on a regular basis. As...
Therapeutic monoclonal antibodies (mAbs) are currently being approved for marketing in Europe and the United States, as well as other countries, on a regular basis. As more mAbs become available to physicians and patients, keeping track of the number, types, production cell lines, antigenic targets, and dates and locations of approvals has become challenging. Data are presented here for 34 mAbs that were approved in either Europe or the United States (US) as of March 2012, and nimotuzumab, which is marketed outside Europe and the US. Of the 34 mAbs, 28 (abciximab, rituximab, basiliximab, palivizumab, infliximab, trastuzumab, alemtuzumab, adalimumab, tositumomab-I131, cetuximab, ibrituximab tiuxetan, omalizumab, bevacizumab, natalizumab, ranibizumab, panitumumab, eculizumab, certolizumab pegol, golimumab, canakinumab, catumaxomab, ustekinumab, tocilizumab, ofatumumab, denosumab, belimumab, ipilimumab, brentuximab) are currently marketed in Europe or the US. Data for six therapeutic mAbs (muromonab-CD3, nebacumab, edrecolomab, daclizumab, gemtuzumab ozogamicin, efalizumab) that were approved but have been withdrawn or discontinued from marketing in Europe or the US are also included.
Topics: Animals; Antibodies, Monoclonal; Drug Approval; Europe; Humans; Immunotherapy; Marketing; Product Recalls and Withdrawals; United States
PubMed: 22531442
DOI: 10.4161/mabs.19931 -
The Medical Journal of Australia Jun 2011
Topics: Arthroplasty, Replacement, Hip; Australia; Hip Prosthesis; Humans; Medical Device Recalls
PubMed: 21692715
DOI: 10.5694/j.1326-5377.2011.tb03141.x -
Plastic and Reconstructive Surgery Jan 2015In 2010 high rupture rates were unexpectedly found among prostheses produced by the French manufacturer Poly Implant Prothèse. Since then, several studies have been...
BACKGROUND
In 2010 high rupture rates were unexpectedly found among prostheses produced by the French manufacturer Poly Implant Prothèse. Since then, several studies have been performed concerning the round implants, but there are still few data available on anatomical implants.
METHODS
From 2003 to 2006 Poly Implant Prothèse implants were employed at the authors' institute for immediate or delayed reconstruction after mastectomy. All implants were anatomical and asymmetrical. In November of 2010, the authors began offering free consultation with a plastic surgeon and radiologist. Demographic data, type of reconstruction, implant lifespan, indications for implant removal, and rupture rate were recorded.
RESULTS
A total of 578 women underwent postmastectomy immediate or delayed reconstruction with 658 Poly Implant Prothèse implants from 2003 to 2006 at the authors' institute. The authors explanted 409 of 443 prostheses, and 34 were explanted at other centers. Eighty-nine patients died and 120 are alive with the implants in place. The mean implant lifespan was 57.5 months, 76 ruptured implants were explanted (18.5 percent), and in 22 cases (5.4 percent), leakage of silicone gel was detected.
CONCLUSIONS
Poly Implant Prothèse implant failure is to be ascribed to shell structure, although the primary safety issue concerned the gel (an industrial-grade and low-cohesive silicone). These issues produce the known rupture rates in the manufacturer's round implants. The authors' use of only anatomical and asymmetrical implants, with their more cohesive silicone gel and more rigid shell allowing a stable form and projection along with a natural feel and touch, probably reduces the rupture rate and silicone spread, although these events remain unacceptably high compared with similar products of other brands.
CLINICAL QUESTION/LEVEL OF EVIDENCE
Therapeutic, IV.
Topics: Adolescent; Adult; Aged; Breast Implants; Cohort Studies; Female; Humans; Medical Device Recalls; Middle Aged; Prosthesis Design; Prosthesis Failure; Retrospective Studies; Silicone Gels; Young Adult
PubMed: 25539293
DOI: 10.1097/PRS.0000000000001007 -
American Journal of Health-system... Feb 2016The characteristics of drug recalls issued over 30 months by the Food and Drug Administration (FDA) were analyzed.
PURPOSE
The characteristics of drug recalls issued over 30 months by the Food and Drug Administration (FDA) were analyzed.
METHODS
All FDA-issued recalls for drugs (prescription and nonprescription, including dietary supplements) and biological products issued from June 20, 2012, to December 31, 2014, were included in this retrospective analysis. Data for all drug recalls were downloaded and sorted by the inclusion criteria from weekly FDA enforcement reports. The following data were analyzed: product type, recall firm, type of recall firm (compounding or noncompounding), country, voluntary or involuntary recall, method of communication of recall, recall number, FDA recall classification (class I, II, or III), product availability (prescription or nonprescription), reason for recall, recall initiation date, and recall report date.
RESULTS
A total of 21,120 products were recalled during the 30-month study period. Of these, 3,045 drug products (14.4%) met the inclusion criteria and were analyzed. A total of 348 total manufacturers were associated with recalled drug products. The 5 firms most frequently involved in recalls accounted for 299, 273, 212, 118, and 112 recalls. The most common reasons for recalls were contamination, mislabeling, adverse reaction, defective product, and incorrect potency. There was a significant association between FDA recall classification and the following outcomes: reasons for recall, product availability, type of recall firm, and form of communication.
CONCLUSION
An investigation of FDA drug recalls revealed that the five most common recall reasons were contamination, mislabeling, adverse reaction, defective product, and incorrect potency. Compounding firms were associated more frequently with contamination than were noncompounding firms.
Topics: Biological Products; Drug Contamination; Drug Labeling; Drug Recalls; Humans; Nonprescription Drugs; Prescription Drugs; Retrospective Studies; Safety-Based Drug Withdrawals; United States; United States Food and Drug Administration
PubMed: 26843501
DOI: 10.2146/ajhp150277 -
Archivos de La Sociedad Espanola de... Jan 2019
Topics: Combined Modality Therapy; Glaucoma; Glaucoma Drainage Implants; Humans; Minimally Invasive Surgical Procedures; Risk Assessment; Safety-Based Medical Device Withdrawals; Stents
PubMed: 30522701
DOI: 10.1016/j.oftal.2018.10.016 -
Acta Orthopaedica Feb 2015
Topics: Bone Cements; Humans; Joint Prosthesis; Medical Device Recalls; Orthopedic Procedures; Product Surveillance, Postmarketing; Prostheses and Implants; Registries
PubMed: 25583041
DOI: 10.3109/17453674.2014.1002184 -
Journal of Medical Internet Research Oct 2020Information provided in an interactive way is believed to be engaging because users can actively explore the information. Yet empirical findings often contradict this...
BACKGROUND
Information provided in an interactive way is believed to be engaging because users can actively explore the information. Yet empirical findings often contradict this assumption. Consequently, there is still little known about whether and how interactivity affects communication outcomes such as recall.
OBJECTIVE
The aim of this study was to investigate mechanisms through which interactivity affects recall of online health information. We tested whether and how cognitive involvement, perceived active control, and cognitive load mediate the effects of interactivity on recall. In addition, we examined need for cognition and health literacy as potential moderators of the mediation effects. Given the increasing popularity of dietary supplement use, our health website focused on this topic.
METHODS
In an online between-subjects experiment (n=983), participants were randomly assigned to control condition (no interactive features), moderate interactivity (dropdown menus), and high interactivity (dropdown menus and responsive infographics). Two weeks before the experiment, background characteristics and moderating variables were measured. During website visit, data on users' online behavior were collected. Recall was measured postexposure.
RESULTS
Participants recalled significantly less information in the moderate (mean 3.48 [SD 2.71]) and high (mean 3.52 [SD 2.64]) interactivity conditions compared with the control condition (mean 5.63 [SD 2.18]). In the mediation analysis, we found direct, negative effects of moderate (b=-2.25, 95% CI -2.59 to -1.90) and high (b=-2.16, 95% CI -2.51 to -1.81) levels of interactivity on recall as well. In the relationship between interactivity and recall, cognitive involvement had a partial negative mediation effect (moderate interactivity: b=-.20; 95% CI -0.31 to -0.10; high interactivity: b=-.21, 95% CI -0.33 to -0.10) and perceived active control had a partial positive mediation effect (moderate interactivity: b=.28, 95% CI 0.18 to 0.40; high interactivity: b=.27, 95% CI 0.16 to 0.40).
CONCLUSIONS
Interactivity decreased recall. In addition, through interactivity participants were less involved with the content of the information, yet they felt they had more control over the information. These effects were stronger in the high need for cognition and high health literate groups compared with their counterparts.
Topics: Drug Recalls; Female; Humans; Male; Medical Informatics; Middle Aged
PubMed: 33112245
DOI: 10.2196/14783 -
Circulation Oct 2018
Topics: Computer Security; Device Approval; Equipment Design; Humans; Medical Device Recalls; Pacemaker, Artificial; Patient Safety; Risk Assessment; Software Design; United States; United States Food and Drug Administration
PubMed: 30354523
DOI: 10.1161/CIRCULATIONAHA.118.037331