Fw: Patients consenting to implants must be willing to assume risks

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From: " ilena rose " <ilena@...>

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Sent: Monday, February 04, 2002 7:40 PM

Subject: Patients consenting to implants must be willing to assume risks

> ~~~ thanks much to ~~~

>

>

> http://www.sesc.org/surgeon/0597abs.htm

>

> 421 Explantation of Silicone Breast Implants

> O. , III, M.D., F.A.C.S., Larry L. Harper, M.D., Song W.

> Wong, M.D., ph P. Michalski, M.D., Curtis N. , M.D.,

> T. , B.S.R.N., B. Rodning, M.D., Ph.D., F.A.C.S.

>

> Mobile, Alabama

>

> Silicone gel-filled breast implants have been employed clinically for

> decades for aesthetic augmentation or postmastectomy reconstruction.

> Most patients and surgeons attest to the efficacy and safety of these

> devices. However, more recently in the medical literature and popular

> media, silicone gel-filled breast implants have been claimed to incite

> an array of clinical sequelae such as capsular formation,

> granulomatous disease, arthritis, arthralgia, fibromyalgia, autoimmune

> collagen vascular disease, human adjuvant disease, siliconosis,

> silicone-related disease, and silicone implant-associated syndrome.

>

> During a recent 24-month period, 25 referred patients underwent

> explanation of bilateral silicone gel-filled prostheses at the

> University of South Alabama. Patient-reported symptoms and signs

> included mastodynia, arthralgia, fibromyalgia, xerophthalmia,

> xerostomia, hypesthesia, and amblyopia. Clinical examination and

> mammography were reliable in diagnosing implant rupture, but only

> re-exploration reliably detected implant leakage. Most patients

> underwent concurrent replacement with saline-filled devices.

>

> Histopathologic analyses of all tissue samples revealed chronic

> inflammation. Subjective improvement of patient-reported symptoms and

> signs occurred over the course of months postoperatively. There was no

> mortality associated with explantation, with or without replacement,

> but an overall morbidity incidence of 20 per cent (5 of 25) was

> observed.

>

> Predicted upon review of the available scientific literature

> and analysis of this modest number of patients, the following

> perspectives are germane.

>

> 1) A small cohort of patients of status

> postimplantation of silicone gel-filled devices will manifest chronic

> morbidity. Identifying such patients prospectively remains

> problematic.

>

> 2) Whether or not silicone gel incites adverse systemic

> phenomena is unproven, although it has been implicated.

>

> 3) Symptomatic patients with silicone gel-filled implants in place should

be

> considered for removal, with full knowledge of the morbidity

> associated with revisional procedures.

>

> 4) Patients currently undergoing breast augmentation or reconstruction

> employing prosthetics are perhaps best served by insertion of

saline-filled

> devices.

>

> 5)Patient-physician dialogue regarding the risk-benefit analysis of

> prosthetic implantation is imperative. Patients consenting to such

> procedures must be willing to assume risks.

>

>