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26. 03.2019

FDA Panel: Too early to pull textured breast implants over cancer risk, need more data

A panel of experts convened by the FDA yesterday said that there’s not enough data to pull textured breast implants from the market over concerns that they may be linked to a type of immune system cancer, according to an AP News report.

The recommendation comes from the first day of a two-day panel meeting discussing the risks associated with breast implant devices, reviewing current study data and exploring how to best track and treat the cancer, and other issues, the devices have been tied to.

The FDA only began reporting on the cancer, known as breast implant-associated anaplastic large cell lymphoma, and its link to implants in 2011. Last month, the federal watchdog said it has received 457 unique reports of the cancer, with 246 new adverse event reports related to it since 2017.

Estimates of the frequency of the disease range greatly, from one in 3,000 to one in 30,000, according to the AP News report. The disease has also been reported to the FDA by patients with smooth implants, and other research has indicated that silicone that leaks from the implant could possibly trigger or exacerbate immune system disorders.

Despite the increased visibility of the cancer and its link to implants, the panel did not recommend any immediate restrictions on the devices, according to the report. The majority of the 19 panelists said that it was too soon to pull the products from the shelves.

Consumer advocates, and the panel’s consumer representative, did not agree, according to AP News. The consumer rep said that many women who receive the implants do so as part of reconstructive surgery following breast cancer surgery, and the risk of subjecting those women to a second cancer was enough to justify their commercial removal.

Panelists were receptive to patient advocates’ calls for more standardized risk disclosures and informed consent for women considering the devices, according to the report.

The panel is meeting again today, continuing to explore how to diagnose and treat the breast implant-linked cancer as well as other concerns related to the devices.

Though they are meeting for another day, the panel is still not expected to recommend a ban on textured implants, according to SVBLeerink analyst Richard Newitter, which is good news for manufacturers of the devices, including Sientra(NSDQ:SIEN) and Johnson & Johnson (NYSE:JNJ) subsidiary Mentor Worldwide.

Both Sientra and Mentor received warning letters last week from the FDA over failures to conduct appropriate post-approval studies of the devices.

“It seems more likely that the panel will focus its “actionable” recommendations on: (a) improved data collection around implants going into patients (at the time of primary & revision surgeries,) (b) stepped up infrastructure/resources to facilitate (possible mandatory) registry participation, (c) more compliant post-surgery surveillance on the part of industry, and (d) a more rigorous approach to informed consent,” Leerink analyst Newitter said in a letter to investors.

Source: MassDevice