Breast Implant Study Should Be Taken with a Grain of Salt, FDA Says

A study linking silicone gel-filled breast implants with several rare diseases should be viewed with caution, according to FDA. The authors of the study, published last week in the Annals of Surgery, say they looked at data from nearly 100,000 breast implant procedures gleaned from FDA-mandated postmarket studies for implants made by Johnson &Johnson's Mentor business, and by Allergan. The analysis showed that silicone implants are associated with higher rates of  Sjögren syndrome, scleroderma, rheumatoid arthritis, stillbirth, and melanoma. The researchers reported that 56% of the implants included in the database were silicone for primary augmentation. They also found that, in the short term, rupture rate is higher for saline-filled implants compared to silicone gel-filled implants (2.5% vs. 0.5%), but capsular contracture, a condition that develops when internal scar tissue forms a tight or constricting capsule around the implant, contracting it until it becomes misshapen and hard, was higher for silicone (5.0% vs. 2.8%). At 7 years, the reoperation rate is 11.7% for primary augmentation and 25% for primary/revision reconstruction. Capsular contracture occurs in 7.2% of primary augmentations, 12.7% primary reconstructions, and is the most common reason for reoperation among augmentations. "Silicone implants are associated with an increased risk of certain rare harms," the authors concluded. "As...
Source: MDDI - Category: Medical Devices Authors: Tags: Implants Source Type: news

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Publication date: Available online 3 June 2020Source: Life SciencesAuthor(s): Jingrun Yang, Kuixia Xie, Chengxin Li
Source: Life Sciences - Category: Biology Source Type: research
CONCLUSIONS: Opiate analgesia can disrupt performance on the Westmead PTA scale in school-aged children resulting in a high false-positive error rate. It is therefore important to record pain medication schedules and interpret results cautiously when opiate analgesia is used following a TBI. Alteration of the method of administration of the memory items should be researched as this may increase the validity of the scale for children with TBI treated with opiate analgesics. PMID: 32497441 [PubMed - as supplied by publisher]
Source: Brain Injury - Category: Neurology Tags: Brain Inj Source Type: research
Dalton Trans., 2020, Accepted Manuscript DOI: 10.1039/D0DT01008A, PaperR. Saravanan, Harkesh B Singh, R. J. Butcher The salt metathesis reaction of two equivalents of 8-lithioquinoline (C6H6NLi) with HgBr2 afforded, bis(quinoline-8-yl)mercury, [(C6H6N)2Hg]. Bis(quinoline-8-yl)mercury has been used for the synthesis of a series of heteronuclear complexes of the... The content of this RSS Feed (c) The Royal Society of Chemistry
Source: RSC - Dalton Trans. latest articles - Category: Chemistry Authors: Source Type: research
Conclusion : at long term, the outcome for PRC remains stable despite some series recently reported worsening of the results due to progressive degenerative arthritis. PRC seems to yield comparable clinical results compared to 4CA but a slightly better range of motion than 4CA. PMID: 32490786 [PubMed - in process]
Source: Acta Orthopaedica Belgica - Category: Orthopaedics Tags: Acta Orthop Belg Source Type: research
Authors: De Smet A, Vanhove W, Benis S, Verstraete M, Hollevoet N Abstract Outcomes of 66 Arpe prostheses in 50 patients treated for osteoarthritis of the trapeziometacarpal joint were investigated with a mean follow-up of ten years. Ten-year survival was 87% when failure was defined as implant removal followed by trapeziectomy and tendon interposition. Ten-year survival was 82% when revision of the cup was also considered as failure and it was 80% when replacement of the neck alone was also chosen as an endpoint. Of the 52 prostheses that were not revised mean DASH score was 11, mean pain score 1.2 and mean score ...
Source: Acta Orthopaedica Belgica - Category: Orthopaedics Tags: Acta Orthop Belg Source Type: research
Authors: Verhulst K, Dauwe J, Van Nuffel M, De Smet L Abstract Trapeziectomy with ligament reconstruction and tendon interposition and trapeziometacarpal prosthesis are two commonly used procedures for first carpometacarpal joint osteoarthritis. The purpose of this study is to compare the short-term outcome of trapeziectomy with ligament reconstruction and tendon interposition to trapeziometacarpal prosthesis. Pubmed, Cochrane library and science direct database were searched with adequate search terms. Used parameters were force, pain, mobility, functionality and complication. All papers describing short-term outc...
Source: Acta Orthopaedica Belgica - Category: Orthopaedics Tags: Acta Orthop Belg Source Type: research
This study reviews a single centre series of prospectively collected outcome measures to determine whether the Mobility performs better than the Scandinavian ankle replacement. The primary outcome measure was the survivorship. Secondary outcome measures consisted of complications and international scoring systems. 147 Scandinavian and 162 Mobility ankle replacements were reviewed at a mean follow up of 12.4 and 7.7 years respectively. The revision rate, which included liner exchange, component exchange or removal of implant was at 7 years 12.3% (18) for Scandinavian and 5.2% (8) for Mobility. The complication rate was 16.5...
Source: Acta Orthopaedica Belgica - Category: Orthopaedics Tags: Acta Orthop Belg Source Type: research
Authors: Wautier D, Ftaïta S, Thienpont E Abstract Aseptic loosening of total knee arthroplasty (TKA) components is one of the frequent reasons for early revision together with infection and instability. Aseptic loosening is usually preceded by the observation of radiolucent lines (RLL) on radiographs. Radiolucent lines have conventionally been considered a sign of osteolysis due to particles disease of either polyethylene or cement wear. However, RLL can be observed quite early after TKA, way before wear and osteolysis can even occur. Immediate postoperative RLL are secondary to surgical technique with either...
Source: Acta Orthopaedica Belgica - Category: Orthopaedics Tags: Acta Orthop Belg Source Type: research
Authors: Van Elst C, Caekebeke P, Vandenneucker H, Bellemans J, Scheys L Abstract Partial meniscectomy is a frequently performed treatment strategy for non-suturable meniscal tears. However, the meniscal volume which can be resected without compromising the load-bearing, shock-absorbing function of the meniscus remains a topic of ongoing research. The aim of this study was to calculate the medio-lateral meniscal volume ratio to estimate this volume. In 90 patients (98 pairs of menisci) without meniscal injury, medial and lateral menisci were segmented on MRI imaging and 3D surface models were created to calculate v...
Source: Acta Orthopaedica Belgica - Category: Orthopaedics Tags: Acta Orthop Belg Source Type: research
Authors: Pool LD, Van Delft D, Thomassen BJ, Keizer SB, Van Arkel ER Abstract Culture of the causative infectious agent is the only definitive method of diagnosing septic arthritis and can be identified by culture of synovial fluid (SF) or by tissue cultures (TC) obtained at surgery. The aim of this study is to compare the cultures of joint needle aspiration (JNA) with tissue cultures obtained at surgery. 52 patients treated for a suspicion of a septic arthritis of the native knee were retrospectively reviewed. In 84% tissue cultures were equal to joint needle aspiration. Median Gächter classification was 1.0 ...
Source: Acta Orthopaedica Belgica - Category: Orthopaedics Tags: Acta Orthop Belg Source Type: research
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